The latest on the Recast, Review, Revision of EU medical devices framework

Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or revision of the EU medical devices directives, however you want to call it in the mean time. I believe the term ‘revision’ is the one for the moment. Today she spoke at the DIA Euromeeting event in Copenhagen, and gave a nice overview of what the Commission presently intends and where it is at with the revision. I’ll try to point out new elements where I thought I noticed them and hope you will forgive me for the condensed language below (which is the price for outscooping the paid-for services).

A new theme is that the Commission looks to take measures also within the existing legal framework pending the Revision, which will take three years to complete at least. These are the measures requested from Commissioner Dalli from the member states recently.

Ms Minor underlined that the medical devices directives have a dual purpose: protect patents and ensure free movement. They have both a healthcare and commercial rationale, Minor emphasizes. The EU must remain innovation-friendly and competitive. The future system will have to accommodate for fact that most companies regulated are SMEs and deal with the increasing interface with pharmaceutical products, mainly with a view to combination products and companion diagnostics.

Theme of the revision will be to  build on the strengths and improve on the weaknesses of the current system. Its major strength is to maintain the delicate balance between pre- and post-market control that has served the EU very well but to ensure safe products entering market and detect issues timely and react.

There is change in expectations of the HCPs and patients compared to 20 years ago, challenges in aging population and health management of chronic diseases. The by now 20 year old system must be changed to account for this.

The Commission plans to adress in future regulation (summary compared against the last Ms Minor speech I visited at the RAPS end 2011):

Scope (nothing new) 

  • (non-viable cells gap and invasive cosmetic devices (cosmetic implants gap)
  • reprocessing of single use devices
  • “in house” tests – level playing field but some leeway for emergency tests
  • genetic tests for non-medical purposes
  • medical devices used for diagnostic services at a distance

Supervision of notified bodies (some newish)

  • Uniform practice for designation and monitoring of notified bodies (more detailed minimum requirements, pre-designation inspection by mixed teams of different member states and perhaps list of EU inspectors (this latter element is certainly newish))
  • uniform standards for conformity assessment (variation in diligence and rigor of notified bodies, create uniform standards – more detailed rules on what is expected from notified bodies)
  • central assessment for new and emerging technologies – central function in the EU for joint assessment of new technologies to ensure common approach (newish too, no clarity as to what this will look like exactly)

Clinical evidence (some newish)

  • Clinical data for pre-market assessment (clarification of data required sufficient for market access, but balance between pre- and post market remains (clearer definition of the clinical evidence “tipping point” marking the moment that market access is possible))
  • Post marketing surveillance (increased role for serious post marketing surveillance in clinical evaluation loop for devices)
  • Rules on clinical investigations and coordination of safety-relsated aspects of the assessment of multinational clinical investigations (make easier to do multi-state trials – rules will be similar to pharma clinical trials directive, concept of sponsor: this is also newish)

Post-market safety (not that much new)

  • Key to EU system – trade-off for relative ease of market access but must be taken seriously by all stakeholders, including notified bodies and member states, and system must ensure consistent and timely reactions to safety issues
  • Enhanced coordination and vigilance cases and market surveillance activities (increased use of Eudamed and EU level trend analysis, EU level trend analysis is new)
  • Enhanced involvement of HCPs and patients in reporting of incidents, because there is currently a big weak point in the directives on this point.
  • No plans currently for GDP, Ms Minor answered to a question from the room.
  • All areas of product are affected by the lack of resources on member states level, said Ms Minor in response to question: safety has a price that member states must be willing to invest in – member states may review financing models and move to fee based financing (notified bodies to pay fee for designation, Eudamed registration fee, among others; should be fairness correction like at EMA currently)

Transparency (nothing new)

  • Central registration of medical devices and relevant economic operators in Eudamed
  • Public access to the Eudamed database (data on whether a device is approved and performance data summary information, like in the US), which will form the basis for EU UDI system

Access to external expertise (nothing new)

  • Panel of scientific and clinical experts will be set up to advise the European Commission on a permanent basis
  • A network of reference laboratories (for IVDs specifically) will be set up, like already happened for food safety and pesticides

Governance (newish)

  • Infrastructure and mechanism for harmonised interpretation and implementation (creation of a new agency will not work for Commisison under current circumstances; expand EMA to take on responsibilities is resisted by industry and Commission is not in favor of it either; Commission preferred solution is stakeholders groups put together in a body tasked with harmonised interpretation)
  • administrative, technical and scientific support (including IT) by EU body
  • cross-sectoral solution of borderline cases (perhaps the Dutch solution I wrote about after last year’s DIA Euromeeting in Geneva)

So, where are we now?

  • Proposal still slated for summer 2012 – proposal somewhat delay compared to April target, Commission did stress test on proposal with PIP cases fall-out and it seems the Commission considers that the outcome of the stress test required not that much adaptation of the proposal (which so far only has been presented in disjointed pieces to the stakeholders, so the entire proposal remains still unclear).
  • Two regulations, one for medical devices and one for IVDs – shorter lead time for entry into force (but, I predict, a more politicized legislative process as that process will be the only opportunity for member states to exercise influence on the resulting legislation)

What will the Commission do in mean time, and what has it asked the member states to do?

A regulation will take about three years to become effective after it enters the legislative process, so what will the Commission do in the mean time and what did it ask the member states to do? Ms Minor mentioned the following:

  • A letter was sent by Commissioner Dalli asking member states to implement a series of measures concerning supervision of notified bodies and enhanced market surveillance (letter not public, contents more or less identical to speech of Commissioner Dalli)
  • Precursor: centralization of vigilance work to expert group at Commission (Commission likely to contract out an analysis of EU level vigilance data to see if there are significant trends)
  • Traceability guidelines to be issued by Commission
  • Patient registries – will they help with traceability and give information about device associated risks?
  • Commission to investigate how healthcare practitioner incident reporting be can improved
  • High level meeting in May with Health Ministers to address the above points.

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