Clinical Evaluation Reports (CERs) and CE certifications under the EU’s previous Medical Device Directive 93/42 EEC (MDD) were historically based only on product equivalency. However, new expectations under MEDDEV 2.7/1 Rev 4 now present challenges for EU medical device manufacturers provided that clinical data expectations under the new Medical Device Regulation (MDR) require more in-depth assessments and increased expectations of Notified Bodies (NBs).
The EU Medical Device Regulation 2017/745 (MDR) substantially tightens the requirements for equivalence justification compared even to MEDDEV 2.7/1 Rev 4, and makes it now almost impossible to leverage a competitor’s clinical data. Although there remains significant uncertainty regarding the MDR – with many implementing and delegating acts to be drafted and approved – in the case of clinical evidence, MEDDEV 2.7/1 Rev 4 provides clear expectations for MDD compliance with Annex X and Annex 7 of the Active Implantable Device Directive 90/385/EEC (AIMD), as well as Art 61 and MDR Annex XIV.
As there are less than two years remaining prior to the MDR enforcement, it is critical that EU device manufacturers prepare now for conformity by May 2020.
In this webinar, NAMSA’s Manager of Medical Writing and Regulatory Services (EMEA), will examine the requirements listed in the MDR and MEDDEV 2.7/1 Rev 4, and discuss why device manufacturers shall not consider the CER a mandatory document for NBs or authorities, but rather as a crucial tool for a smooth transition for MDR and beyond.
Time will also be allotted for Q&A.
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About the Presenter
Paul Malinovski is based in Berlin and serves as NAMSA’s Manager of EMEA Medical Writing and Regulatory Services. Prior to joining NAMSA, Paul worked at UL-MDT as Managing Director (MDT) and Regional Operations leader (UL). Mr. Malinovski has also held the position of Senior Regulatory Affairs Manager at Zimmer Biomet where he was responsible for global regulatory affairs on bone cements, including combination products. Paul has a wealth of expertise in global regulatory affairs, including the geographies of Europe and Russia, in addition to Medical Writing for CERs per MEDDEV.