Eucomed Sounding Doubtful That EU Parliament “Improvements” To Device Regulation “Will Not Slow Down Approval Process”

In short

Back in April we had a bit of a go at the European Parliament (EP) for what we considered to be an ill-considered and populist stance on some elements of medical device regulation, namely the “EuroPMA”. Our piece, entitled “EU falls into regulatory knee-jerk trap in response to PIP scandal” can be found here.

Clearly paying no heed to li’l old us, the Eurocrats have now endorsed the wording that was proposed in April’s committee meeting. And Eucomed has responded.


The Parliament fully endorsed the wording that was originally proposed by the Environment and Health Committee (ENVI) on April 26.

The adopted resolution calls on the Commission for measures to increase patient safety and improve the current regulatory system, in line with Eucomed’s proposal, a principle we’re fully behind. Measures, many of which were discussed at yesterday’s UK Parliamentary Select Committee Meeting,  include:

• the strengthening of the designation and control of Notified Bodies in the EU, also with respect to their skills and resources;

• better vigilance reporting and coordination of member states on incident assessments;

• increased and unexpected controls of manufacturers by notified bodies based on experience from the post-market phase;

• establishing tools to ensure the traceability of devices, in particular implants;

• establishing registers for implants and having the registers interconnected.

All good stuff, especially if it improves the competence of (and with it confidence in) the Notified Body component.

However, the EP also called for – although with a thin majority – a Pre-Market Authorisation (PMA) system for medical devices, as is already the case for pharmaceuticals.

Industry body Eucomed has leapt into the fray

It is arguing that adopting a pharma-like system for devices:

  • would not address the different nature and innovation cycles of medical technologies.
  • would not lead to an effective increase in patient safety, but may cause years of delay in the availability of medical technology solutions to European citizens and a loss of European innovation competitiveness compared with other regions.

Eucomed’s position is that Europe already today has a pre-market approval mechanism in place for high-risk devices which has proven to deliver a high level of safety and provides European citizens with access to innovation 2-3 years before their US counterparts.

Eucomed says that Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence. And we agree with that too. Complexity and more pre-market hurdles will only stifle what is a generally good system and at huge cost to manufacturers who would certainly be picking up the tab.

So then, in accepting the words of EU Commissioner Dalli that mechanisms would enhance patient safety and would not slow down the approval process, Eucomed is throwing down the gauntlet to the EP to make sure this remains the case.

Source: Eucomed