Regulatory Open Forum

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw

Hi,

Clause 6.2.3 requires the CER to be updated at least annually for high risk or new devices, and every 2 to 5 years for lower risk, well-established devices. A justification for the frequency of updates will be required. For all risk classifications of devices, the CER will need to be updated whenever new information from the Post Market Surveillance (PMS) affects the evaluation or its conclusions. 

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw

Hi,

Clause 6.2.3 requires the CER to be updated at least annually for high risk or new devices, and every 2 to 5 years for lower risk, well-established devices. A justification for the frequency of updates will be required. For all risk classifications of devices, the CER will need to be updated whenever new information from the Post Market Surveillance (PMS) affects the evaluation or its conclusions. 

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw

The EU MDR doesn't prescribe the frequency at which CERs are to be updated.  Modeling this, the MDCG (2020-13) has left manufacturers the liberty to, "...Identify when updates to the clinical evaluation report shall be assessed during the surveillance and post certification monitoring activities and which frequency should be considered...".  Consequently, yes, the frequency of updates is generally up to the manufacturer's discretion. Yet that must be appropriate risk-based discretion.

While MEDDEV 2.7/1 revision 4 gives specific guidelines (specifically, update at least annually if the device carries significant risks or is not yet well established; or every 2 to 5 years if the device is not expected to carry significant risks and is well established), we need to remain sensitive to the fact that MEDDEV 2.7/1 isn't generally intended for the EU MDR.  Nonetheless, for now, the Notified Bodies and other Union authorities are still often generally tolerant of that MEDDEV in my experience as along as its prescription is reasonable for the subject device.  Otherwise, the manufacturer is required to tailor the frequencies to its particular device scenario.

Hi,

Clause 6.2.3 requires the CER to be updated at least annually for high risk or new devices, and every 2 to 5 years for lower risk, well-established devices. A justification for the frequency of updates will be required. For all risk classifications of devices, the CER will need to be updated whenever new information from the Post Market Surveillance (PMS) affects the evaluation or its conclusions. 

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw

Dear Anon

The MEDDEV 2.7/1 (Rev 4) appears on the MDCG endorsed documents web site (Medical Device Coordination Group established under the MDR).

Further information and the link to this document is found here:

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en<o:p></o:p>

Presently, some manufacturers make a proposal to their notified body on the frequency of CER updates with the rationale i.e. well established technology, etc.. For instance, updating a CER every three to five years for well established class IIB or III has been accepted by some notified bodies. Other notified bodies may ask that the CER update coincides with the PSUR. Maybe there will a MDCG in the future on this topic.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 21-Feb-2023 10:16
From: Anonymous Member
Subject: Clinical Evaluation Report Frequency

This message was posted by a user wishing to remain anonymous

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw

This is great feedback!  I work with a lot of well established IIB devices and 3 to 5 years makes a lot of sense to me.  Thank you!

Dear Anon

The MEDDEV 2.7/1 (Rev 4) appears on the MDCG endorsed documents web site (Medical Device Coordination Group established under the MDR).

Further information and the link to this document is found here:

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en<o:p></o:p>

Presently, some manufacturers make a proposal to their notified body on the frequency of CER updates with the rationale i.e. well established technology, etc.. For instance, updating a CER every three to five years for well established class IIB or III has been accepted by some notified bodies. Other notified bodies may ask that the CER update coincides with the PSUR. Maybe there will a MDCG in the future on this topic.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 21-Feb-2023 10:16
From: Anonymous Member
Subject: Clinical Evaluation Report Frequency

This message was posted by a user wishing to remain anonymous

Under the EUMDR, is it up to the manufacturer to establish the frequency of which CERs are updated?  Is it the same for all device classifications?  Where is this defined?  Is there flexibility?

Thanks in advance btw