Minister warns on medical device rule change

Rules devised by the European Commission in wake of PIP breast implant scandal

Ireland has raised objections to one of the key aspects of proposed new rules for the medical devices industry, with Minister for Health James Reilly questioning whether a new layer of authorisation of products is needed.

Speaking following a meeting of EU health ministers in Brussels yesterday, Dr Reilly said that while patient safety was paramount, a balance should be struck to ensure patients had swift 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 said, noting that Europe already had "excellent, reliable authorities".

New rules on the regulation of medical devices, which cover everything from hip replacements to stents, were devised by the European Commission in the wake of the PIP breast implant scandal, in which French company Poly Implant Prothèse (PIP) supplied faulty products to hundreds of thousands of women. The scandal prompted concerns that the EU system, which allows companies to seek authorisation from certified bodies in other member states, is under-regulated, particularly in comparison to the US system.

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However, representatives of the Irish medical devices industry, which employs approximately 25,000 people, have argued that the new rules could threaten the industry in Ireland by delaying when products can come to market and introducing excessive bureaucracy, leaving Europe at a competitive disadvantage to the US.

Yesterday, the founder of PIP was sentenced to four years in prison by a French court for his role in the breast implant scandal.

Jean-Claude Mas was convicted of aggravated fraud by a court in Marseille, while four other former executives at the company also received prison sentences.

Suzanne Lynch

Suzanne Lynch

Suzanne Lynch, a former Irish Times journalist, was Washington correspondent and, before that, Europe correspondent