HBI Deals+Insights / News

Is the EU speeding towards FDA-style regulation?

There is a new threat to healthcare companies across Europe which, HBI hears, has the potential to be more impactful than either Covid or Brexit as far as costs are concerned.

European Union Medical Device Regulation is now in force following a transition period, and it strengthens the existing regulatory system for medical devices in Europe in a way many operators find unpalatable.

The new rules – mirrored in the UK by a parallel system – could see the EU lurching towards a US style FDA approach. This requires more clinical evidence before devices can pass muster – at additional cost.

Operators tell us this additional paperwork isn’t required for safety – though historians might point to the PiP scandal and disagree. But it appears to be indisputable that costs will rise as a result, and entirely possible that some services which are fringe to the operator but could be vital to the patients concerned could be lost.

The UK stands slightly apart at the moment – in that it has its own regime but it mirrors that in force now on the continent. Critics say it could do one of two things – introduce even tighter controls (which they fear) or loosen them, but the second option isn’t embraced by manufacturers selling abroad for whom it would be harder to produce two tiers of goods than one standard product to a higher spec.

In any event, price inflation is sure to follow.

We would welcome your thoughts on this story. Email your views to David Farbrother or call 0207 183 3779.