Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Hello,

You need to read the information in the EU IVDR related to Article 110 and the information you placed here is quite clear: 'was drawn up prior to 26 May ...' What this means if the Declaration of Conformity is done and product placed on the market, then it has been placed for the first time on the market.  Meaning basically if the product has not been sold prior to 26 May 2022, then by default would go under compliance of EU IVDR.  There is further information contained in the Progressive Roll-out document for those dates, that is not contained in the EU IVDR currently.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 31-Mar-2022 03:15
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Hi Anon,

In addition to the revised Article 110(3), Article 110(4) clearly states that 'Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025..."

Another important document for clarifying these requirements is the CAMD FAQ Transition Sub Group IVDR. Keep in mind that the document has not been updated to align with the amended IVDR, so it may not track perfectly with the current revision. Of note is question 16 that clarifies the intent of the "sell off" provision where it states, "It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor. When reading this, apply the original Article 110(3) that only allowed for placing on the market an IVDD device after DoA if it had a certificate issued by a Notified Body. This did not include self-declared devices. 

Also critical to understanding how to interpret these regulations is the Blue Guide that provides the seminal definitions for placing on the market, making available, and putting into service, along with clarifications for how these should be interpreted. 

Good luck!

------------------------------
Christie Hughes MT(ASCP), MPH
Principal Consultant
Austin, TX
United States
------------------------------

Original Message:
Sent: 31-Mar-2022 03:15
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Dear Christie,

As a response to your message I would like to cite Kevin Randell who wrote:
""Be sure you have a proper understanding of the 'placing on the market' concept, which, time and again, has been discussed previously here in the Forum.  Indeed, as the Commission has acknowledged, that concept is confusing and thus easily misunderstood.  Specifically, remember that 'placing on the market' is not a model-based or family-based or type-based concept.  Instead, it is a unit/shipment-based concept."

So placing on the market/placing for the market for the first time, is referring to specific shipments (batches). It does not mean putting a product as a whole (for the first time) on the market.
'Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025..." this statement does only refer to devices (shipments) that have been  placed before the date of application. Here we are talking about placing after the date of application with a (self)declaration of conformity drawn up before the 26 May 2022.

As mentioned in posting 3 reads, I would think that drawing up the DoC before the 26 May 2022 is sufficient to place devices on the market after that date. Furthermore, there is no concept for a product family/type placed on the market, only a concept for shipments.

Therefore saying: "if the DoC was drawn up and product placed on the market before the DoA" would not make sens to me in the global concept since it would only "validate" that specific shipment not the product as a whole. 

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------

Original Message:
Sent: 05-Apr-2022 17:27
From: Christie Hughes
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hi Anon,

In addition to the revised Article 110(3), Article 110(4) clearly states that 'Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025..."

Another important document for clarifying these requirements is the CAMD FAQ Transition Sub Group IVDR. Keep in mind that the document has not been updated to align with the amended IVDR, so it may not track perfectly with the current revision. Of note is question 16 that clarifies the intent of the "sell off" provision where it states, "It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor. When reading this, apply the original Article 110(3) that only allowed for placing on the market an IVDD device after DoA if it had a certificate issued by a Notified Body. This did not include self-declared devices.

Also critical to understanding how to interpret these regulations is the Blue Guide that provides the seminal definitions for placing on the market, making available, and putting into service, along with clarifications for how these should be interpreted.

Good luck!

------------------------------
Christie Hughes MT(ASCP), MPH
Principal Consultant
Austin, TX
United States

Original Message:
Sent: 31-Mar-2022 03:15
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Hi all, 
Recently I contacted a German CA and asked similar questions.
See below my questions and their answers. 

My Questions: 

Their answers: 

Hope this will help.

Nataliya

------------------------------
Nataliya Kuras
QA/RA Director
London
United Kingdom
------------------------------

Original Message:
Sent: 05-Apr-2022 17:27
From: Christie Hughes
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hi Anon,

In addition to the revised Article 110(3), Article 110(4) clearly states that 'Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025..."

Another important document for clarifying these requirements is the CAMD FAQ Transition Sub Group IVDR. Keep in mind that the document has not been updated to align with the amended IVDR, so it may not track perfectly with the current revision. Of note is question 16 that clarifies the intent of the "sell off" provision where it states, "It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor. When reading this, apply the original Article 110(3) that only allowed for placing on the market an IVDD device after DoA if it had a certificate issued by a Notified Body. This did not include self-declared devices.

Also critical to understanding how to interpret these regulations is the Blue Guide that provides the seminal definitions for placing on the market, making available, and putting into service, along with clarifications for how these should be interpreted.

Good luck!

------------------------------
Christie Hughes MT(ASCP), MPH
Principal Consultant
Austin, TX
United States

Original Message:
Sent: 31-Mar-2022 03:15
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Hello Nataliya,

Many thanks for sharing this.
From this its seems to me obvious that the first placing on the market can happen after the 26th may if the Doc has been drawn up before that date, and this shall also be valid for:

Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------

Original Message:
Sent: 10-Apr-2022 14:23
From: Nataliya Kuras
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hi all,
Recently I contacted a German CA and asked similar questions.
See below my questions and their answers.

My Questions:

Their answers:

Hope this will help.

Nataliya

------------------------------
Nataliya Kuras
QA/RA Director
London
United Kingdom

Original Message:
Sent: 05-Apr-2022 17:27
From: Christie Hughes
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hi Anon,

In addition to the revised Article 110(3), Article 110(4) clearly states that 'Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025..."

Another important document for clarifying these requirements is the CAMD FAQ Transition Sub Group IVDR. Keep in mind that the document has not been updated to align with the amended IVDR, so it may not track perfectly with the current revision. Of note is question 16 that clarifies the intent of the "sell off" provision where it states, "It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor. When reading this, apply the original Article 110(3) that only allowed for placing on the market an IVDD device after DoA if it had a certificate issued by a Notified Body. This did not include self-declared devices.

Also critical to understanding how to interpret these regulations is the Blue Guide that provides the seminal definitions for placing on the market, making available, and putting into service, along with clarifications for how these should be interpreted.

Good luck!

------------------------------
Christie Hughes MT(ASCP), MPH
Principal Consultant
Austin, TX
United States

Original Message:
Sent: 31-Mar-2022 03:15
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?

Thank you Nataliya for sharing this information for the wider audience. 

In our case, our authorized representative in EU has told us that we need to complete the 'IVDR legacy review' with them before placing the device (for which DoC is issued under IVDD) on market after 26th May 2022. Do you think once we complete the review and ready to put the devices under IVDR, do we still need to register with DMIDS in spite of registering our firm details in EUDAMED (for SRN)?

Appreciate your view on this.

Thank you,
Sravan

------------------------------
Sravan Kumar Manchikanti
Hyderabad
India
------------------------------

Original Message:
Sent: 10-Apr-2022 14:23
From: Nataliya Kuras
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hi all,
Recently I contacted a German CA and asked similar questions.
See below my questions and their answers.

My Questions:

Their answers:

Hope this will help.

Nataliya

------------------------------
Nataliya Kuras
QA/RA Director
London
United Kingdom

Original Message:
Sent: 05-Apr-2022 17:27
From: Christie Hughes
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hi Anon,

In addition to the revised Article 110(3), Article 110(4) clearly states that 'Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025..."

Another important document for clarifying these requirements is the CAMD FAQ Transition Sub Group IVDR. Keep in mind that the document has not been updated to align with the amended IVDR, so it may not track perfectly with the current revision. Of note is question 16 that clarifies the intent of the "sell off" provision where it states, "It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor. When reading this, apply the original Article 110(3) that only allowed for placing on the market an IVDD device after DoA if it had a certificate issued by a Notified Body. This did not include self-declared devices.

Also critical to understanding how to interpret these regulations is the Blue Guide that provides the seminal definitions for placing on the market, making available, and putting into service, along with clarifications for how these should be interpreted.

Good luck!

------------------------------
Christie Hughes MT(ASCP), MPH
Principal Consultant
Austin, TX
United States

Original Message:
Sent: 31-Mar-2022 03:15
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Dear Richard,

Thanks for your answer. I am talking about general IVD that will be upclassified to class B, C or D.

IVDR amendment reads:
Devices for which the conformity assessment procedure pursuant to
Directive 98/79/EC did not require the involvement of a notified body,
for which a declaration of conformity was drawn up prior to 26 May
2022 in accordance with that Directive and for which the conformity
assessment procedure pursuant to this Regulation requires the
involvement of a notified body, may be placed on the market or put into
service until the following dates:
(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile
condition.

So, I don't see the requirement that it must have been placed (for the first time) on the market prior to May 26, 2022.

We really want to do it "by the book" independently of whether it will be verified or not. But I don't see any requirement here for being on the EU market prior to May 26, 2022. How did you come to your conclusion. Is it written elsewhere in the regulation?

Kind regards
Original Message:
Sent: 31-Mar-2022 02:47
From: Richard Vincins
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

Hello Anon,

It depends on what class this General IVD medical device will be according to the EU IVDR.  There is the Progressive Roll-out where there are some years now for compliance depending on the class of device.  Maybe to answer your question, if the new IVD medical device if not "on the market" prior to 26 May 2022 then compliance with the IVDR is needed.  But who will be checking?  Not sure.  Though at least when you go through your EU IVDR certification (if you are going through with Notified Body) some checks may be made at that time.  A Declaration of Conformity needs to be drawn up and product on the market prior to 25 May 2022 in order to continue offering the product.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 30-Mar-2022 11:06
From: Anonymous Member
Subject: Placing a new (general) IVDD product on market with DoC after 26th May 2022

This message was posted by a user wishing to remain anonymous

Hello,
if I understand the (transitional provisions art. 110 of) IVDR correctly, a newly developed general IVD can be placed on the EU market after the 26th May 2022 with an Declaration of Conformity according to IVDD, if that DoC has been drawn up by the 25th May 2022. No placing of that product on the EU market prior to 26th May 2022 is required.

Is this assessment correct?