Is your old CER still compliant under MDR?

by | Oct 20, 2021 | Clinical Writing, MDR | 0 comments

CE-marked clinical evaluation

Revamped your device’s CER in the last 24 months? If the answer is NO, then there’s a high likelihood that your ongoing compliance is at risk. IMed’s Chief Medical Writer Ana Quinn offers a really quick way to double check your current status.

Clinical evaluations were always a requirement under MDD, however the scope and emphasis are more important under MDR. We’ve written about medical writing and clinical evaluations in the past, but as a refresher, the clinical evaluation is part of the medical device development and must comply with the general safety and performance requirements so that the device can be approved and CE-marked – or if it’s already CE-marked, for it to remain that way.

The MDR brought with it, a lot of new requirements and some of them can be confusing,. So we’ve created an easy checklist to help IMed clients quickly assess if your previous CER is still compliant under the new requirements or if it needs updating.

If you answer “no” to any of the questions in the table below, then your clinical evaluation is no longer compliant (for class I devices) or about to become uncompliant from May 2022 (for class IIa and above).

Clinical evaluation compliance question under MDR

Yes

No

Are any of the safety and/or performance claims substantiated by grey publications (unpublished reports)?

 

 

Did you include a similar severity and stage of the disease, on the same site and in similar patient populations in terms of age, anatomy and physiology (among others) for equivalence assessment?

 

 

Did you include a PMCF plan?

 

 

Did your state-of-the-art cover benefits and risks of alternative therapies?

 

 

Did you cover known/anticipated adverse events and their type and frequency?

 

 

Did you list clinical safety and performance claims?

 

 

Did you include a summary of safety and clinical performance?

 

 

Class IIa and above only: Did you already have a PSUR and trend reporting to reference in the CER?

 

 

Class III and implantables only: Did you have a clinical investigation for your device?

 

 

Outside of these most obvious new requirements, there’s also now a requirement to update the CER throughout the life cycle of the device. This needs to be at least annually for devices with significant risks or not yet well established or 2 to 5 years for other devices; also taking into account notified body surveillance audits and certificate renewals.

These CER updates will also need to:

  • Confirm that there is still clinical evidence to conform with the general safety and performance requirements.
  • Confirm if there is still consistency between the analysed data and current knowledge/the state-of-the-art.

If you’re not sure whether you need to update or upgrade your clinical evaluation, or if you know you do but need help to write a new CEP/CER, IMed’s clinical specialists are here to help. But please book in with us as soon as possible, so that we can work on your CER and ensure your business stays compliant. You can contact IMed’s Medical writers on 01295 722800 or email us at hello@imedconsultancy.com.

Ana Quinn

Ana Quinn

RA & Clinical Consultant

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