Medical Devices | Industry Suggestions to Make Europe’s New Regulatory System Work
We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike.
Last week, at the Association of the European Self-Medication Industry’s (AESGP) regulatory conference, I presented MedTech Europe’s vision to the Heads of EU Medicines Agencies. In most Member States, these agencies are the home of our IVD and medical device competent authorities, meaning that the heads of these agencies bear ultimate responsibility for the successes (and failures) of our present regulatory journey.
Building on MedTech Europe’s political messages for a successful IVDR and MDR implementation, our messages to the regulatory leaders are:
The new Regulations are 2-3 times larger than the former Directives and they’re more detailed and burdensome, for business and for regulators. Good regulatory practice states that authorities need expertise and resources proportionate to the legislation they implement.
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