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.