Sep 26, 2013

Results from a recent survey by European medical technology trade group Eucomed suggest that medical device companies operating in the European Union may face compliance cost increases of up to € 17.5 billion through 2020 depending on whether a centralized premarket authorization system proposed as part of Medical Devices Directives revisions (draft Regulation) becomes law.

Although only 19 Eucomed member companies participated in the survey, the organization argues that a "consistency of input" from respondents across all categories allows for broader extrapolation.

Some components of the European directives revisions—as well as their associated costs—garnered support from survey participants. Proposed Unique Device Identification (UDI), labeling and clinical performance data improvements and administrative requirements all received positive responses from survey participants, even though these measures are expected to cost industry about € 7.5 billion.

Respondents expressed little to no support, however, for a proposed European Commission scrutiny procedure (article 44 of the draft Regulation) that Eucomed has argued will not lead to improved patient safety in the EU, but could total as much as € 2.5 billion in compliance costs for firms.

Industry respondents also oppose a European Parliament Rapporteur proposal for a centralized premarket authorization system, which Eucomed estimates would cost manufacturers as much as € 17.5 billion and complicate device market authorizations.

Under the proposed premarket authorization system, small and medium-sized enterprises (SMEs) could each face between € 7 and € 28 million in costs for European medical device registration through 2020, according to survey estimates; larger manufacturers and sponsors could face registration costs of € 15 million or more.

"Anything that protracts the CE Marking certification process and delays marketing authorization (and adds expenses) will obviously concern medical device firms," says Evangeline Loh, Vice President of Global Regulatory Affairs at Emergo Group. "There is also a question of whether these measures would enhance patient safety. It's still a dynamic situation, though, in terms of what the final Medical Device Directives revisions will require. These survey figures are substantial, but they’re also preliminary."


  • Stewart Eisenhart