Ireland Balking at EU Medical Device Rule Change

Not all European Union (EU) member states are supportive of proposed new rules for the medical device industry.

Ireland’s Health Minister, James Reilly, questions whether a new layer of product authorization is truly needed. Though patient safety certainly is important, he believes a balance must be struck to ensure sick people have quick access to products.

“There is really very little to be gained, I believe, from having yet another layer of pre-authorisation in place which will only serve to slow down the access of EU citizens to these medical devices, many of which are truly life-saving,” he told The Irish Times, adding that Europe already has “excellent, reliable authorities.”

New medical device regulation rules, which cover a gammut of products from hip replacements to heart stents, were devised by the European Commission to keep faulty devices from hitting the market. The move was triggered by the 2011 PIP breast implant scandal, in which French company Poly Implant Prothèse (PIP) supplied faulty products to hundreds of thousands of women (the company’s founder received a four-year prison sentence on Dec. 10 for his role in the caper; four other former executives are serving prison terms as well). Fallout from the atrocity prompted the Commission to re-examine its medtech regulation rules, which allows companies to seek authorization for their products from certified bodies in other member states.

Reilly would rather leave the approval process unchanged, preferring to leave product authorization to independent organizations known as “notified bodies,” which sanction most devices on a relatively quick timeline. The Commission’s proposed rule changes would, in part, add a new bureaucratic layer to the process — a body of experts designed to handle regulating high-risk devices. It also calls for the creation of an implant registry. In addition, the changes would boost requirements for the groups to ensure they meet “up-to-date qualification requirements.”

Reilly’s sentiments have been echoed by Ireland’s 25,000-workforce-strong medical device industry and medtech groups worldwide. Industry representatives contend the new rules could add too much bureaucracy and give the United States the advantage in terms of medical device product development. Ireland’s position carries added weight, because many medical device companies maintain manufacturing or research operations in the country.
There is still time to change the final outcome, so dissent matters. In October, the European Parliament advanced its proposed regulatory changes. And EU member states and the European Council must vote, after which Parliament and council members will develop a final law.