Recast of Device Directives: The Dialogue Continues, Sort of

On 8 May, the European Commission (EC) launched a public consultation on the need to develop a new framework for the regulation of medical devices. It cited a number of reasons for engaging this dialogue, notably inconsistent safeguards for public health among member states, new technologies that the present directives are ill-equipped to regulate, and variances in national transpositions. The EC invited comments and suggestions and made available to stakeholders an online questionaire with a July 2 deadline. Industry was not impressed.

Just ahead of the deadline, COCIR, EDMA, EHIMA, EUCOMED, EUROMCONTACT, EUROM VI, and FIDE, which represent 95% of Europe’s medical device industry, issued a statement that began as follows: “The industry feels strongly that there is no evidence-based justification of the need for a recast of the MDDs.” Industry has been well served by the new-approach directives, and the notion that the very foundation of the medical device directives might be called into question understandly made its collective hackles rise. Writing in the 5 September issue of Clinica, European regulatory affairs editor Amanda Maxwell suggests that industry might want to reconsider its approach. (The Clinica article is accessible only to subscribers.)

“Denial of—or merely resistance to—the possible transformations ahead will only serve to close off avenues of discussion that are currently open and which industry now has the opportunity to influence,” she writes in the lead article of the 5 September issue of Clinica. “But the responses that have been made public so far by stakeholders seem to mainly reflect hostility to all possible change and have fallen short . . . of representing the active engagement in dialogue that the Commission was seeking,” she adds.

All is not lost however: Maxwell writes that there have been unofficial reports that the EC is still open to contributions from stakeholders, if they are constructive and, especially, substantiated by data. It is understood that EUCOMED is making the most of this opportunity, she adds.

Stay tuned.

Tags: EU Regulatory