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I understand the existing requirement for updating Clinical Evaluation Reports with respect to current safety and performance information. But, I was wondering if there is also an expectation to update Clinical Evaluation Reports with the other new requirements mentioned in the Rev. 4 MEDDEV document. As an example, would a CER performed using a prior MEDDEV version now have to be updated to include a specific identification of the “State of the Art” product(s)? In addition, would the CER author now be required to complete a “Statement of Interest”? Thank you in advance. source: https://www.linkedin.com/groups/78665/78665-6202643771381944322 Marked as spam
 Posted by Asked on November 11, 2016 12:00 am
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Private answer
Marcelo Antunes
The requirement to keep clinical evaluation up-to-date to the state of the art is not new, although it was implicit in the past and it's now explicit in the new MEDDEV. But, as the essentials requirements of the MDD already required that the design has to be " taking account of the generally acknowledged state of the art, this already include clinical evaluation. So yes, any CER performed previously will have to incude this.
Please note that there is an expectation that all CERs are updated to the new expectations of Revision 4, anyway. So ALL CER's performed previously will have to include all new expectations of Rev 4. Related to interest, the expectation is that all evaluators have a clear declaration of interests so it's clear that they are not under pressure to reach their conclusions. Marked as spam
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Private answer
Daniel John
Soon MDR will replace the EU’s current MDD (93/42/EEC) and the EU’s Directive on AIMD (90/385/EEC). Proposed MDR requires Identification of “qualified person” within the organization who is ultimately responsible for all aspects of compliance with the requirements of the new MDR. The organization must also document the specific qualifications of this individual relative to the required tasks. This "qualified person" could also double up as your CER author who has to complete a "Statement of Interest" in compliance with MEDDEV 2.7/1 rev. 4.
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Private answer
Daniel John
"New requirements" in MEDDEV 2.7/1 rev. 4 includes, (a) Qualifications of authors and evaluators & (b) Access to data for equivalent devices. Rest of the changes are "additional clarifications" to MEDDEV 2.7/1 rev. 3. But the implementation of MEDDEV 2.7/1 rev. 4 depends on the NB since the MEDDEV 2.7/1 rev. 4 is dated June 2016. I have recently (Jan to Nov. 2016) completed recertification of our 09 Class III devices and our NB did not insist compliance with MEDDEV 2.7/1 rev. 4. Probably rev 4. might come into effect along with MDR in 2017 with a three-year transition period for medical devices and five years for IVDs manufacturers.
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Private answer
Hi Marcello,
BSI presented on MEDDEV 2.7.1 Rev 4, top 10 key changes. It also includes MDR relevant information.The webinar and presentation is available online. It's very useful and clearly sets out BSI transition expectations. Other NB's may operate differently. Best of luck. Marked as spam
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