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 to 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 regulatory requirements in Europe.
It is important to recognize 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; however, these changes are not unexpected and new, but rather a harmonization of the 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 rather respected regulatory entities implementing and maintaining a transparent regulatory framework for medical device approvals in Europe, including enforcement tasks and extended powers (e.g. unannounced audits).
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 substantial equivalency evaluation against legally marketed predicate devices.
- Harmonization and of investigational study designs and clinical study endpoints for high-risk devices.
- Continual and pro-active update of 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 – e.g. 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.
Nevertheless, medical device manufacturers already familiar with US-510 (k) and PMA Submissions in the US will not find these concepts and definitions new and challenging.
|Proposed European Medical Device Regulations||US FDA Medical Device Regulation|
|Transparency & Traceability||
|Legal Compliance Responsibilities||
The main objective of the European Medical Device Regulation is to harmonize regulatory requirements among European Member States, specifically for high-risk devices and long-term implants. A closer look reveals another objective—to provide regulatory consistency with international pre- and post-approval requirements for commercial distribution of medical devices in major healthcare markets.
For medical device manufactures addressing global healthcare markets and opportunities, none of the above requirements and concepts may present an undue burden, but rather provide more certainty to succeed in different market places. Similar, but conceptually different requirements may still exist.
However, this as a first European Harmonization attempt, and the three (3) year transition period may be considered a comprehensive learning curve for all stakeholders.