Post-market clinical follow-up (PMCF) is a relatively new requirement for the EU medtech sector. It is detailed for the first time in the EU's new Medical Device and IVD Regulations.
EU Post-Market Clinical Follow Up: What Manufacturers Need To Know
The EU's new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What do they entail, and why are there problems in understanding what will be required? Consultant Sarah Sorrel offers insights in an interview with Medtech Insight.
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Existing legislation already offers a route, albeit rarely used, for orphan and innovative devices to reach the market more quickly. It should be used more; manufacturers and notified bodies do not need to wait for official changes to the EU’s medtech regulations.
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Insight into the knock-on effects on innovation adoption and procurement is keenly awaited by medtechs.
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Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.
If medtech becomes embroiled in the EU-US trade war, access to critical and innovative medical devices will be under threat.
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If medtech becomes embroiled in the EU-US trade war, access to critical and innovative medical devices will be under threat.
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The US FDA is seeing more staff turnover this week, with CDRH deputy director for science Douglas Kelly announcing his departure while the agency gets a new chief counsel and chief of staff.
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Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?