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EU Legislative Reform
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
“What a mess! … The MDR is a complete disaster,” critics tell European Commission.
With so many discussions around future change now in the medtech regulatory melting pot as 2025 kicks off, it is unsurprising to see an intense calendar of EU meetings ahead. But which topics deserve the most focus?
Medtech Insight spoke to eight well-known EU regulatory experts to find out what developments they expect to see, what they fear and their wish list for 2025.
Only a week ago, the European Commission launched a consultation to which medtech stakeholders were invited to reply. Now it has launched a survey. Why two separate calls in one month and how will that information be used?
Following the Council of the EU’s early December meeting, a strong consensus is emerging among industry and policymakers on the nature of many aspects of the much-needed reform of the EU’s medtech regulations.
With debate intensifying in the EU over potential EMA oversight of device regulation, life sciences lawyer, Alison Dennis, is advocating for a distinct European Devices Agency to streamline and improve current regulations.
There is considerable pressure now on the European Commission to complete its targeted evaluation of the EU’s medical device regulations and start rectifying many of its shortfalls that are impacting patients and industry alike
Centralized regulation will be beneficial for classification and borderline decisions, orphan device decisions, and recertifying notified bodies. But it is not a panacea for EU medtech in the view of Sabina Hoekstra-van den Bosch.