Global Regulatory Pulse

The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices

In Consulting, European Market, Regulatory by Stephan Buttron

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
  • Universal Device Identifier (UDI).
  • The summary of safety and clinical performance for class III devices including aspects of the safety and performance characteristics from the clinical evaluation in a publicly available document.
  • Proposed Centralized European Portal for reporting Adverse Events and Field Safety Corrective Actions.
  • Universal Device Identifier (UDI).
  • Safety and Effectiveness Summaries for 510(k) and PMA devices are publicly available.
  • Clinical study results on safety and effectiveness is mandatory labeling information for high-risk PMA devices.
  • Centralized Medical Device Reporting and Field Safety Corrective Action System.
Patient Safety
  • Mandatory scientific clinical study evidence for safety and performance prior to marketing for high-risk and long-term implant devices.
  • Scrutiny on analytical preclinical test data to confirm safety and functional performance for high-risk and all implant devices.
  • Periodic Post-Market Surveillance and Trend Report on safety and performance.
  • Post-Market Clinical Study requirements to complement limited pre-market clinical study data.
  • Scientific Clinical Study evidence to confirm safety and effectiveness is required for novel and High-Risk (PMA) devices.
  • Preclinical safety and functional performance requirements for novel and high-risk devices might be subject to a rigorous review and approval process.
  • Annual PMA Summary Reports including trend reports on adverse events and device malfunctions.
  • Post-Market Clinical Study requirements as part of the conditions for approval.
Legal Compliance Responsibilities
  • Sponsor Concept for Clinical Studies.
  • Dedicated Person responsible for legal compliance with MDR requirements.
  • Sponsor is responsible for clinical study submission, management, financing, and follow up.
  • Owner/Operator responsibility for legal compliance.

Conclusion

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.

Authors:

Stephan Buttron currently serves as NAMSA’s Senior Product Development Strategist. Mr. Buttron has over 20 years’ experience in achieving EU, U.S. FDA and other international regulatory medical device approvals and registrations. He has provided global consulting services on regulatory strategy development to medical device manufacturers regarding least burdensome pathways 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 specialty branches. Stephan is considered a key industry thought leader on risk management, and has 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. Mr. Buttron has also provided countless educational opportunities to international organizations regarding medical device design and development issues related to ISO 13485 & EU MDD 2007/47 compliance.