On May 25th 2016, the European Commission released the long awaited draft for the proposed European Medical Device Regulation (MDR). Though not in its final implementation format, the consolidated text is expected to be translated into the 24 official European working languages prior ratification by the European Parliament in late 2016/early 2017. The transition period is 3 (three) years ending in late 2019/early 2020. By the end of the transition period, all medical devices have to comply with these new regulatory requirements in Europe.
Important to recognize is the legal character of the MDR. The regulation is not a European Directive having to be transposed and released into national law (with deviations), but constitutes binding jurisdiction for all CE/Marked devices approved for commercial distribution and - without national deviations.
The new MDR will definitively implement changes, not unexpected new changes, but rather harmonizing existing concepts of medical device approvals for all European Medical Device Manufacturers:
Transitioning Role and Tasks for Notified Bodies (NB). NBs are no longer contracting partners collaborating with the Medical Device Industry, but becoming respected regulatory entities to implement and maintain a transparent regulatory framework for medical device approvals in Europe including enforcement tasks and extended authorities e.g. unannounced audits and inspections.
New or different Clinical Evidence for all devices and specifically new clinical data requirements for high- risk devices including all long-term implant devices.
- Significantly reduced equivalency evaluation options against legally marketed predicate devices.
- Harmonization of investigational study designs and study endpoints for high risk devices
- Continual and pro-active update of experienced clinical performance with mandatory follow-up summary reports to Regulatory Bodies and other Stakeholders and economic partners.
- Stricter control over associated economic operators i.e. supply chain, distributors, and importers and authorized representatives.
- New and different labeling requirements (UDI and Public Statements of Safety and Clinical Performance)
New Challenges and Opportunities:
Among those proposed changes are regulatory concepts that are already well known from other international regulatory jurisdictions for medical devices most prominently from the US-FDA.
Many of these concepts were already included in the current European MDD (M5), however, not explicit enough to be implemented into mandatory regulatory requirements. This may have led to a different understanding and continuing divergence of regulatory compliance among European Notified Bodies and Member States.
However, those medical device manufacturers already familiar with US-510 (k) and PMA Submissions in the US will not find these concepts and definitions unfamiliar and overly challenging.
Join Stephan Buttron, Principal Medical Research Manager Regulatory Affairs, as he talks about these new changes and the challenges device manufacturers will face.
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Stephan Buttron has over 20 years experience in achieving EU, US-FDA and world-wide regulatory medical device approvals and registrations. He has provided international consulting services on regulatory strategy development to medical device manufacturers for a least burdensome pathway for 510(k)/PMA and MMD-CE mark applications. He has successfully managed FDA pre-submission meetings for Investigational Device Exemption (IDE) pathways with multiple FDA speciality branches.
Stephan has also provided multiple training sessions to medical device manufacturers on structured risk management process per EN ISO 14971 & EU MDD 93/42 as amended with directive 2007/ 47. He has also provided training on Medical Device Design & Development issues to comply with ISO 13485 & EU MDD 2007/47.
Mr. Buttron has performed various quality system site audits and is a BSI and TUV certified lead auditor for EN ISO 13485 Quality Management Systems and EN ISO 14971 Risk Management.