Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

Hi,
There will be certainly no renewal under MDD because no new certificate under MDD can be issued past May 25, 2020.
This because the MDD ceases to be valid 25. May 2020.
You need to apply to your NB NOW for getting certified to MDR or negociate with them IMMEDIATELY a renewal under MDD, some still do for existing clients, some dont.
Also check with your NB whether they go for MDR and whether they will keep your scope, if not, you must look for another NB.
The date when EUDAMED goes live is not communicated yet, you will have according articles 120 - 123 transition time for filling in EUDAMED, time depends on communication "go life" in OJ of the EU.
The information to enter is communicated in the relevant guidance for data fields, see EU website.
In case of further questions you may get in touch with us at medidee.com
Best
Michael

------------------------------
MichaelMaier
Senior Partner
Switzerland / Germany / Belgium / Denmark / USA
michael.maier@medidee.com
------------------------------

Original Message:
Sent: 26-Jul-2019 15:06
From: Anonymous Member
Subject: CE Certificate

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

Thank you. I appreciate your response. It was very helpful.

------------------------------

Regulatory Affairs Coordin
United States
------------------------------

Original Message:
Sent: 27-Jul-2019 13:12
From: Michael Maier
Subject: CE Certificate

Hi,
There will be certainly no renewal under MDD because no new certificate under MDD can be issued past May 25, 2020.
This because the MDD ceases to be valid 25. May 2020.
You need to apply to your NB NOW for getting certified to MDR or negociate with them IMMEDIATELY a renewal under MDD, some still do for existing clients, some dont.
Also check with your NB whether they go for MDR and whether they will keep your scope, if not, you must look for another NB.
The date when EUDAMED goes live is not communicated yet, you will have according articles 120 - 123 transition time for filling in EUDAMED, time depends on communication "go life" in OJ of the EU.
The information to enter is communicated in the relevant guidance for data fields, see EU website.
In case of further questions you may get in touch with us at medidee.com
Best
Michael

------------------------------
MichaelMaier
Senior Partner
Switzerland / Germany / Belgium / Denmark / USA
michael.maier@medidee.com

Original Message:
Sent: 26-Jul-2019 15:06
From: Anonymous Member
Subject: CE Certificate

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

Original Message------

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

To follow on what has been said, you might be too late to renew your CE Certificate under the MDD because that "window" for renewal has based for some Notified Bodies (early in 2019) because they are now concentrating on EU MDR.  If you plan to get a new certificate under EU MDR, as indicated there is not a renewal to MDR as it is a brand new certificate, you need to have those discussions with your Notified Body when they will be designated.  If your certificate expires March 2020 you may have a very, very small window to get a EU MDR certificate.

EUDAMED is scheduled for March 2020, but this is under the presumption everything is working as planned.  At a minimum, EUDAMED implementation will be a phased approach and if March 2020 happens it will probably only be "module" covering facility registration - SRN number - and maybe device registration.  Areas like vigilance and UDI may coma later.​

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 27-Jul-2019 19:49
From: John Beasley
Subject: CE Certificate

Dean Anom,

There are several unknowns with respect to answering your question.  Is your Notified Body designated under the EU-MDR?  Is your Notified Body one of those who have announced they will not pursue EU-MDR?  Have you made an application to CE Mark your Class III device under the EU-MDR?

Also, note that you cannot "renew" an MDD certificate as "MDR".

My guess would be that your certificate will be renewed as MDD and given an expiration date that aligns with the final transition for devices.

EUDAMED is expected to be ready March 2020. Details regarding the required information to enter is available from the Internet.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

With regards to Eudamed, ​MDCG documents (MDCG 2019-4 and 2019-5) have brought some clarifications to the deadlines for submission of the UDI core data elements:
1/ If Eudamed is on time (EU Commission o publish a notice in the Official Journal of the EU by 25 March 2020), the mandatory registration of device and UDI data elements listed in MDR Annex VI Part A (section 2) and Part B shall be applicable from 18 months after MDR Date of Application. In other words you can upload the device data from MArch 2019 if you wish to and this voluntary registration will end on 26 November 2021. This is valid for all risk classes, for MDD and MDR devices (i.e. "Legacy devices" included!!).
HOWEVER: As from 26 May 2020, the full registration of devices remains a pre-condition as part of reporting of serious incident in Eudamed. Therefore, if you have an incident report, you are required to submit the data core elements in Eudamed for the concerned device (again independently of the fact your device is already MDR compliaint or MDD compliant).
2/If Eudamed is delayed, the device registration transition time starts with the Date of Notice Publication in the EU Official Journal (Art 34.3) and ends 24 months later.


------------------------------
Sylvie Couderc RAC
Regulatory Affairs Director
Pont de Claix
France
------------------------------

Original Message:
Sent: 28-Jul-2019 00:22
From: Richard Vincins
Subject: CE Certificate

To follow on what has been said, you might be too late to renew your CE Certificate under the MDD because that "window" for renewal has based for some Notified Bodies (early in 2019) because they are now concentrating on EU MDR.  If you plan to get a new certificate under EU MDR, as indicated there is not a renewal to MDR as it is a brand new certificate, you need to have those discussions with your Notified Body when they will be designated.  If your certificate expires March 2020 you may have a very, very small window to get a EU MDR certificate.

EUDAMED is scheduled for March 2020, but this is under the presumption everything is working as planned.  At a minimum, EUDAMED implementation will be a phased approach and if March 2020 happens it will probably only be "module" covering facility registration - SRN number - and maybe device registration.  Areas like vigilance and UDI may coma later.​

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 27-Jul-2019 19:49
From: John Beasley
Subject: CE Certificate

Dean Anom,

There are several unknowns with respect to answering your question.  Is your Notified Body designated under the EU-MDR?  Is your Notified Body one of those who have announced they will not pursue EU-MDR?  Have you made an application to CE Mark your Class III device under the EU-MDR?

Also, note that you cannot "renew" an MDD certificate as "MDR".

My guess would be that your certificate will be renewed as MDD and given an expiration date that aligns with the final transition for devices.

EUDAMED is expected to be ready March 2020. Details regarding the required information to enter is available from the Internet.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

As always your response was very helpful Richard. I appreciate you taking time to answer the queries we all post on this forum.
Thank you.

------------------------------
Pooja Rathor
Regulatory Affairs Coordinator
Bowdoin ME
United States
------------------------------

Original Message:
Sent: 28-Jul-2019 00:22
From: Richard Vincins
Subject: CE Certificate

To follow on what has been said, you might be too late to renew your CE Certificate under the MDD because that "window" for renewal has based for some Notified Bodies (early in 2019) because they are now concentrating on EU MDR.  If you plan to get a new certificate under EU MDR, as indicated there is not a renewal to MDR as it is a brand new certificate, you need to have those discussions with your Notified Body when they will be designated.  If your certificate expires March 2020 you may have a very, very small window to get a EU MDR certificate.

EUDAMED is scheduled for March 2020, but this is under the presumption everything is working as planned.  At a minimum, EUDAMED implementation will be a phased approach and if March 2020 happens it will probably only be "module" covering facility registration - SRN number - and maybe device registration.  Areas like vigilance and UDI may coma later.​

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 27-Jul-2019 19:49
From: John Beasley
Subject: CE Certificate

Dean Anom,

There are several unknowns with respect to answering your question.  Is your Notified Body designated under the EU-MDR?  Is your Notified Body one of those who have announced they will not pursue EU-MDR?  Have you made an application to CE Mark your Class III device under the EU-MDR?

Also, note that you cannot "renew" an MDD certificate as "MDR".

My guess would be that your certificate will be renewed as MDD and given an expiration date that aligns with the final transition for devices.

EUDAMED is expected to be ready March 2020. Details regarding the required information to enter is available from the Internet.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.

Thank you. I appreciate your response. It was very helpful.

------------------------------
Pooja Rathor
Regulatory Affairs Coordinator
Bowdoin ME
United States
------------------------------

Original Message:
Sent: 27-Jul-2019 19:49
From: John Beasley
Subject: CE Certificate

Dean Anom,

There are several unknowns with respect to answering your question.  Is your Notified Body designated under the EU-MDR?  Is your Notified Body one of those who have announced they will not pursue EU-MDR?  Have you made an application to CE Mark your Class III device under the EU-MDR?

Also, note that you cannot "renew" an MDD certificate as "MDR".

My guess would be that your certificate will be renewed as MDD and given an expiration date that aligns with the final transition for devices.

EUDAMED is expected to be ready March 2020. Details regarding the required information to enter is available from the Internet.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

This message was posted by a user wishing to remain anonymous

Hello everyone,
I was hoping to get some information on the renewal of a current CE certificate. Our current Class III product CE certificate expires on March 2020. The MDR transition begins May 2020. So in this case will our certificate be renewed to MDD or MDR? My understanding is we need to fill out an application to our NB to set up a conformity assessment (TD review,audits) before we can qualify for MDR.

Also,does any one know when is the  EUDAMED database expected to go live?? What information will feed into this database in terms of existing, approved CE marked products??

Any information will be greatly appreciated.
Thank you.

Regulatory Affairs Coordinator.