Regulatory Open Forum

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Hi Dan,

Thanks for your detailed and quick answer. I appreciate.

But to clarify I know and have already read / work on, prepare, ... several time the MDR. My apologies if, while I wanted to be straight to the QMS point, I had not adapted my wording to the new MDR wording. And of course I know that we need to kind of restart from scratch for almost everything and that there is no transfer from MDD to MDR. And I know that notified body needs to be accredited (almost none apart 2 are currently and one is BSI UK...) and that before this accreditation almost nothing could be officially done (apart of course a looooot of upfront preparation). This is already in discussion with our notified body.

My question was really on the QMS audit part (that they never ever highlighted ...). I really thought that the 2 certificates (MDD / EN ISO 13485) were in fact, more independent, but that no QMS audit would have been required at the exact moment of EC Certificate start to MDR (if I can say it like that). Even if, yes there are several new QMS requirements in the MDR, I was sure that they were going to be reviewed but I didn't expected them to be instantly reviewed. Even if, of course, some records of it (like PSUR, CER, ...) will be submitted / reviewed at the moment of the submission of the Technical documentation. Of course all that depends of our conformity assessment path and classification level (IIa not modified by MDR).

So in summary, if I read your email you effectively confirm the absolute need of an MDR QMS-related audit. This is what I quite understood from our auditor.

Note: I have already sent extensive question on this to our NB manager, I would be pleased to provide the info when received. If this interest anyone.

Regards,

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

I don't know what will happen or how it will work. There have not been any announcements of the contingency plan.

I'm going to be an optimist!

The initial plan was to have EUDAMED up and running by May 2020, but the EU-MDR has provisions for delay. I infer that the EU prepared contingency plans, but they are not yet public. I expect the contingency plans would cover the recently announced two-year delay.

In addition, I suspect that some manufacturers and NBs have exercised the contingency plan. We know that from the Date of Application is was possible to apply the MDR CE Mark to some products. We also know that some companies have the MDR CE Mark for products that are not Class I because the NBs have issued press announces. I looked on the company's website to see if they had a copy of the certificates since I was curious how they did it without Eudamed. I didn't find them.

In my optimistic mode I expect an MDCG guidance "any day now". There could even be a new correction document instead of guidance documents.

The good news is that you don't need a single registration number, SRN, now. Article 31 explains that Eudamed is necessary to issue the SRN. Article 123(3)(d) say that if Eudamed is not ready in time, the provisions of some articles don't apply until six months after the notice that it works. Article 31 is one of those articles.

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

I don't know what will happen or how it will work. There have not been any announcements of the contingency plan.

I'm going to be an optimist!

The initial plan was to have EUDAMED up and running by May 2020, but the EU-MDR has provisions for delay. I infer that the EU prepared contingency plans, but they are not yet public. I expect the contingency plans would cover the recently announced two-year delay.

In addition, I suspect that some manufacturers and NBs have exercised the contingency plan. We know that from the Date of Application is was possible to apply the MDR CE Mark to some products. We also know that some companies have the MDR CE Mark for products that are not Class I because the NBs have issued press announces. I looked on the company's website to see if they had a copy of the certificates since I was curious how they did it without Eudamed. I didn't find them.

In my optimistic mode I expect an MDCG guidance "any day now". There could even be a new correction document instead of guidance documents.

The good news is that you don't need a single registration number, SRN, now. Article 31 explains that Eudamed is necessary to issue the SRN. Article 123(3)(d) say that if Eudamed is not ready in time, the provisions of some articles don't apply until six months after the notice that it works. Article 31 is one of those articles.

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

I don't know what will happen or how it will work. There have not been any announcements of the contingency plan.

I'm going to be an optimist!

The initial plan was to have EUDAMED up and running by May 2020, but the EU-MDR has provisions for delay. I infer that the EU prepared contingency plans, but they are not yet public. I expect the contingency plans would cover the recently announced two-year delay.

In addition, I suspect that some manufacturers and NBs have exercised the contingency plan. We know that from the Date of Application is was possible to apply the MDR CE Mark to some products. We also know that some companies have the MDR CE Mark for products that are not Class I because the NBs have issued press announces. I looked on the company's website to see if they had a copy of the certificates since I was curious how they did it without Eudamed. I didn't find them.

In my optimistic mode I expect an MDCG guidance "any day now". There could even be a new correction document instead of guidance documents.

The good news is that you don't need a single registration number, SRN, now. Article 31 explains that Eudamed is necessary to issue the SRN. Article 123(3)(d) say that if Eudamed is not ready in time, the provisions of some articles don't apply until six months after the notice that it works. Article 31 is one of those articles.

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

I don't know what will happen or how it will work. There have not been any announcements of the contingency plan.

I'm going to be an optimist!

The initial plan was to have EUDAMED up and running by May 2020, but the EU-MDR has provisions for delay. I infer that the EU prepared contingency plans, but they are not yet public. I expect the contingency plans would cover the recently announced two-year delay.

In addition, I suspect that some manufacturers and NBs have exercised the contingency plan. We know that from the Date of Application is was possible to apply the MDR CE Mark to some products. We also know that some companies have the MDR CE Mark for products that are not Class I because the NBs have issued press announces. I looked on the company's website to see if they had a copy of the certificates since I was curious how they did it without Eudamed. I didn't find them.

In my optimistic mode I expect an MDCG guidance "any day now". There could even be a new correction document instead of guidance documents.

The good news is that you don't need a single registration number, SRN, now. Article 31 explains that Eudamed is necessary to issue the SRN. Article 123(3)(d) say that if Eudamed is not ready in time, the provisions of some articles don't apply until six months after the notice that it works. Article 31 is one of those articles.

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"

Thank you for posting this. It is quite interesting.

I compared it with the requirements for NB certificates in the EU-MDR Annex XII, Chapter II. I didn't see any issues.

One issue that has come up is the single registration number, SRN. Annex XII, Chapter II(4) says, "if already issued, the SRN of the manufacturer referred to in to Article 31(2)". Since the certificate doesn't have an SRN, I infer one has not yet been issued.

However, I noticed that it is a quality management certificate, so it falls under Annex XII, Chapter I(4.b).

I also noticed that as a quality management certificate it cites the QMS in Article 10(9), but does not cite any version of ISO 13485:2016. The standard could be in the referenced report.

I don't know what will happen or how it will work. There have not been any announcements of the contingency plan.

I'm going to be an optimist!

The initial plan was to have EUDAMED up and running by May 2020, but the EU-MDR has provisions for delay. I infer that the EU prepared contingency plans, but they are not yet public. I expect the contingency plans would cover the recently announced two-year delay.

In addition, I suspect that some manufacturers and NBs have exercised the contingency plan. We know that from the Date of Application is was possible to apply the MDR CE Mark to some products. We also know that some companies have the MDR CE Mark for products that are not Class I because the NBs have issued press announces. I looked on the company's website to see if they had a copy of the certificates since I was curious how they did it without Eudamed. I didn't find them.

In my optimistic mode I expect an MDCG guidance "any day now". There could even be a new correction document instead of guidance documents.

The good news is that you don't need a single registration number, SRN, now. Article 31 explains that Eudamed is necessary to issue the SRN. Article 123(3)(d) say that if Eudamed is not ready in time, the provisions of some articles don't apply until six months after the notice that it works. Article 31 is one of those articles.

First, you must change your assumptions about any linkage between the MDD and the MDR. There is none. As a manufacturer you must start all over and any certificates you have from the MDD have no value for the MDR. (There is an exception under Article 120, but you didn't ask that question.)

In addition, the Notified Bodies must also start over. Nothing from the MDD carries over for them either. Worse, until they are designated under the MDR, they cannot answer MDR questions. All of this is creating some confusion.

Also, the language changes so you no longer have an EC Technical File.

For the MDR, starting from scratch, you will follow the basic steps below. I don't claim this is the full list, but it will get you started.

Enter the information in Eudamed to register as an economic operator – manufacturer

Obtain a Single Registration Number, SRN, from the Competent Authority

(Note that none of this works yet)

For every device for which you intend to apply the CE Mark, determine its class under MDR Annex VIII

For every such device assign a Basic UDI-DI

For every device enter the device registration information in Eudamed (This doesn't work yet either)

Determine a Notified Body designated under the MDR

(Note, today there are only two – soon to be only one)

Provide your SRN, the device classes, and the Basic UDI-DIs to the potential MDR NB

Expect to complete a detailed application form

Determine a conformity assessment path – I recommend Annex IX

Read through all the requirements in Annex IX

Read through Table 1 of CEN/TR 17223:2018

Prepare your QMS and technical document according to Annex I, Annex II, and Annex III

The NB will do a QMS audit to the MDR QMS requirements – EN ISO 13485:2016 is not adequate

The NB will do technical documentation audit for either every device or on a sampling plan as described in Annex IX

After you pass, the NB will issue all of the certificates and you will happily apply the MDR CE Mark

After completing all of this, as they say on Star Trek, "Live long and prosper!"