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Comparing and Contrasting Global Regulatory Requirements for Clinical Evaluation Reports (CERs). Highlighting: Japan, China, Europe, Australia and ASAEN

Monday, June 4; 10 AM – 11 AM
Presenter:
Barb Atzenhoefer, Principal Product Development Strategist (NAMSA)

Description
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities have historically been a critical part of conformity with the Medical Device Directive 93/42 EEC (MDD) and Active Implantable Device Directive 90/385/EEC (AIMD). However, over the last year, there has been an increased emphasis on PMS and PMCF compliance initiatives under the new EU Medical Device Regulation 2017/745 (MDR).

The amplified focus on post-market activities is partially due to the absence of “grandfathering” of product conformity under the EU MDR; all existing medical device products will be required to demonstrate full compliance with the increased expectations of the EU regulation. Further, there is significant risk of the removal of products from the EU market as a result of non-adherence to the new requirements for CE certification – even for manufacturers currently holding CE marks. As a result, there is an urgent need for manufacturers to: ensure that existing PMS processes and outputs are robust; plan and implement PMCF activities to fill any gaps and support maintenance on the EU market; and confirm that the availability of clinical data to support ongoing CE certification upon MDR implementation.

This session will include an in-depth exploration of EU MDR requirements so attendees may:

  • Understand the impact of the MDR to devices that are currently CE-marked
  • Evaluate weaknesses in existing PMS data

Learn how to leverage PMS data to support compliance with the new regulation