EU

It is time for companies to take part in cross-country health technology assessments and stop only asking “what’s in it for me?”

An agreement between the EU and Switzerland potentially opening the way for renewal of the MRA – enabling barrier-free cross-border medtech trade – could be concluded as early as December. More good news for Switzerland, relating to the acceptance of FDA-approved products into the country, could follow in Q1 2025.

The European Parliament wants the European Commission to revise the Medical Device Regulation within 100 days. But EU member state authorities warn of the consequences of rushing matters.

The problems besieging the EU medtech industry are already too serious and in need of urgent remedy to wait any longer for change, industry says in open letter to the European Commission.

The proposed new EU guidance will focus on the regulatory and methodological aspects of clinical trial design and marketing authorization for tRPs, according to a concept paper that has just been issued for public consultation.

Delegates from European institutions and industry representatives unpacked the many challenges of improved access to critical medicines on the continent in a session at this year’s European Health Forum.

The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.

The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.

Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.

Just as manufacturers need to implement corrective and preventive action plans, so this is an essential part of how a notified body functions; new guidance explains how.