MEPs will debate new amendments to the controversial medical devices directive today ahead of a key vote on the legislation later this week in Strasbourg.
Representatives of the Irish medical devices industry, which employs around 25,000 people, have argued that the new rules could threaten the industry in Ireland by delaying the length of time products can come to market and introducing excessive bureaucracy.
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, which saw French company Poly Implant Prothese (PIP) supply faulty products to hundreds of thousands of women.
The cornerstone of the European Commission’s proposals is a new centralised authorisation system to regulate medical devices or products, as well as on-site product checks. Currently, companies seek authorisation from so-called “notified bodies” which are regulated by each member state.
Last month, the European Parliament’s committee for environment, public health and food safety proposed further changes to the legislation, including the introduction of pre-market authorisation system alongside the notified bodies system.
Pre-market approval
However, a number of MEPs on the committee, including Irish MEP Mairéad McGuinness, have secured an amendment to remove the requirement for pre-market approval ahead of this week's vote. The additional pre-authorisation process will now apply only if there are particular concerns about specific products.
“This additional layer of scrutiny will run in parallel to the work of the notified bodies,” Ms McGuinness said. “This legislation is about ensuring patient safety and industry certainty. We do not want companies to stop innovating because the legislation is too cumbersome. That’s important not only for the companies concerned, but also for patients who should not be denied access to life-saving products.”
Ms McGuinness said increased supervision after a product is certified is also essential, noting that, in the case of the PIP scandal, the composition was changed after the certification was granted.
Industry lobby groups, including the Irish Medical Devices Association, have argued strongly that the new legislation will increase bureaucracy without necessarily improving patient safety. It argues that the new legislation could delay the route to market by three years, and will significantly impact Europe's competitiveness.
The current European regulatory environment for medical devices is much more liberal that the US system, which requires medical device products to be approved by the FDA (Food and Drug Administration). As a result, many US manufacturers first market their products in Europe.
German concerns
Other countries with concerns about the legislation include Germany, which has a strong medical devices industry. However, Ireland has the highest proportion of people working in the industry of any country in the European Union. Exports of medical devices and diagnostics products represent around 8.5 per cent of total merchandise exports here.
Ireland’s sizeable medical devices industry dates back more than 40 years with the arrival of US multinational companies. Today, multinationals account for around half of the 250 medical devices companies operating in Ireland, with the remainder SMEs, many of which were formed as spin-offs.
While MEPs will vote on the directive this week, the European Council, which represents the views of the 28 member states, must formulate its own position on the legislation, after which both sides will begin negotiations on a final text.
