EU

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

A short consultation has been launched by the UK MHRA on elements of devices regulation for Great Britain that have evolved since the first consultation on UKCA marking in 2021.

The EU’s PRRC role can differ substantially according to the circumstances at individual companies. But there is a need to further understand and shape PRRC's responsibilities so there is strong consistency across the board, PRRCs and associated stakeholders heard recently in Malaga.

Medtech engineering association shares concerns over regulations, innovation and EU competitiveness with remainder of medtech industry.

European cross-border HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, say Nordic health technology assessment experts. Talks on HTA collaborations outside Europe are also underway.

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.