There are fears that Ireland’s medical devices industry could be under threat from new EU legislation that aims to tighten up regulatory control of the European medical devices industry.

The European Parliament’s environment committee yesterday backed stringent new laws on medical devices which the industry claims could delay the route to market for new medical technology by up to three years.

About 25,000 people work in Ireland’s medical devices industry, which comprises a mix of multi-national and smaller indigenous companies that design and manufacture everything from wheelchairs to cardiovascular stents. Ireland has the highest proportion of people working in the industry of any country in the European Union.

The move to tighten up regulation of medical devices at an EU level comes in the wake of the breast implant scandal, which saw French medical devices company Poly Implant Prothese (PIP) sell sub-standard breast implants to hundreds of thousands of women.

Just over a year ago the European Commission published a proposal to update the EU Medical Devices Directive, including new rules on assessment, testing and traceability.

MEPs have added hundreds of amendments to the initial proposal, which was backed by the environment committee yesterday.



Securing agreement

A vote on the amendments will be taken by the European Parliament next month in Strasbourg. This will then pave the way for negotiations to commence with the European Council, which represents the views of the 28 EU member states, with the intention of securing agreement before the European Parliament breaks up for elections in May.

But industry players fear that the new regulation, which introduces a number of pre-market authorisation rules and the establishment of a new centralised European authorisation agency, could significantly reduce the speed at which medical products get to market. Currently, Europe is at a competitive advantage to the US due to the speed at which companies can develop products.

Vice chairman of the Irish Medical Devices Association and Cooke Medical executive Bill Doherty said the new proposals were unworkable and did not guarantee patient safety, and added: “Europe and Ireland are in danger of losing their innovative edge.”