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A crucial document for industry, the roadmap to the implementation of the EU's new medtech rules, finally seems on the cusp of readiness – four months after the rules entered into force.



EU Roadmap



The long-awaited roadmap to the implementation of the Medical Devices and IVD Regulations, being drafted by the European Commission in conjunction with the Competent Authorities for Medical Devices (CAMD) group, should be ready within the next few weeks, sources suggest.



The hope is that the final roadmap will be available by mid-October, ahead of a stakeholder day on the new regulations that will be jointly organized by the Commission and CAMD on October 18. Other medtech sector stakeholders, such as notified bodies and industry, will also be invited.



This event had not been widely publicized, but it is an event that had been called for by former head of regulations at the Medtech Europe industry association, John Brennan, as providing "a critical opportunity for the regulatory authorities, notified bodies and industry to identify and prioritize shared concerns that need urgent attention." (Also see "Q&A: With New EU Regs Taking Effect, What Can Industry Do To Be Proactive?" - Medtech Insight, 28 Apr, 2017.)



Niall MacAleenan, a member of the executive group of the CAMD and medical device lead at the Irish Health Products Regulatory Authority (HPRA), told Medtech Insight the roadmap is intended be a practical guide for regulatory authorities and the Commission to work together towards implementation.



MacAleenan, who made emphasized that he was giving his own opinions rather than an official CAMD view, added that the mapping process will hopefully increase clarity, avoid duplication and identify challenges to address.



It will also be fluid: The roadmap could change over time with changing priorities when new challenges are identified, he said.



The work itself outlined in the roadmap will by and large be taken forward by the different working groups, and will involve industry, Medtech Insight understands. "The roadmap is useful," MacAleenan noted, "but much more important is ensuring participation and resource from all involved to achieve the implementation work."



The Seven Priority Clusters

The draft roadmap that was shared in March features seven different proposed implementation priority clusters, each including multiple work items. It is not expected that the basic structure has not changed since then.



The seven road map priority clusters decided in the latter part of last year are:


  1. Notified bodies, including how to get them redesignated, as well as addressing capacity issues;
  2. Clinical issues, including drafting common specifications and more clarity on clinical evaluations and equivalence issues;
  3. Issues surrounding classification and scope, including reclassifying some devices from the legacy device directives to the Medical Device Regulation, as well as new rules for software and aesthetic devices;
  4. Registration, including Unique Device Identification, looking at how the supply chain deals with the single registration number, and implant cards;
  5. Market surveillance, including looking how to coordinate liability;
  6. Vigilance, including looking at periodic safety update reports, how the Eudamed medical device database can be integrated, and how data can be used for improving patient safety and oversight of the system; and
  7. IVD-specific issues, including companion diagnostics.


Why Is Roadmap Important To Industry?


Industry is hoping that the publication of the roadmap will also help confirm timeframes for compliance, as there are many derogations, or exceptions, in both the device and IVD texts, and these are creating some difficulty in interpretation.



MedTech Europe has been working on its own best-practice guides for its industry members addressing each of the main areas of implementation. The trade association is keen to access the final roadmap to see if there are any additional items that need addressed or that need to be re-prioritized.



What It Does Not Do


One matter the roadmap will not address is setting out how notified body designations will be managed. That will be a specific operational aspect that will be discussed by the relevant working groups and by implementing measures from the EU Commission, MacAleenan said. Draft implementing measures have already been made public. (Also see "Notified Bodies Apply For EU MDR/IVDR Designations Despite Document Shortfall" - Medtech Insight, 14 Sep, 2017.)



Nor will the roadmap will set out details regarding the delegated and implementing acts for the new regulations.



MacAleenan said the roadmap "may point to the potential for working groups to contribute to the development of implementing measures in different areas. However, the requirement for these, the order in which they will be produced and corresponding timelines will be addressed separately by the EU Commission.



IVD Issues


There have been questions about how issues related to the implementation of the IVD Regulation are being managed within the roadmap. When it comes to IVDs, MacAleenan explained that the roadmap has an IVD-specific workstream to address issues that are only relevant to the IVD Regulation. The other IVD aspects, he said, are best captured in the specific technical cluster to which they are relevant or in circumstances when they are general/horizontal aspects.

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