For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this date, non-compliant companies will lose their CE-mark certification and the right to sell to the European market. Compared to the MDD, the MDR 2017/745 takes a more life-cycle approach that is very similar to the one advocated by the FDA. The regulations feature several significant changes including new regulations associated with Vigilance and Post-Market Surveillance, Scope and Classification of Products, Changes affecting Notified Bodies, Unique Device Identification (UDI), changes in Safety and Performance Requirements, Person Responsible for Regulatory Compliance, etc. This transition also places a greater emphasis on clinical data and clinical evaluations with the introduction of strict rules for clinical investigations and alignment to the Clinical Trials Regulation.
The MDR implementation means updates to QMS documents that were based on the old Medical Device Directive, 93/42/EEC. The documentation impacted include those covering:
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In order to help you prepare for EU MDR implementation, Rook Quality Systems have compiled new MDR templates that will bring your QMS up to speed with the new regulations and help you in the transition process by offering you all the procedural templates, including the associated forms. We also offer a MDR transition checklist to help facilitate the process. If you have any other questions regarding your transition, feel free to contact us at email@example.com and ask how we can help get your QMS ready for MDR.