Tighter Regulations On Breast And Hip Implants Passed

Product liability experts at Irwin Mitchell welcome the stricter requirements for medical devices that have been approved by Health Committee MEPs.

Yesterday Health Committee MEPs approved plans for stricter monitoring and certification procedures to ensure traceability of medical devices, as well as legislation to tighten up information and ethical requirements for diagnostic medical devices such as those used for DNA testing. New regulations will take effect on notified bodies which provide European conformity CE marks for products to be legally marketed in the European Union (EU).

Rapporteur on medical devices, Glenis Willmott (S&D, UK), said: "The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorise medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, will be subject to additional assessments by experts before they can be authorised.”

The Committee also agreed to a “much stronger system of post-market surveillance” so that problems can be identified more promptly.

Following the Poly Implant Prothese (PIP) scandal that emerged in 2010, women were left uncertain about whether or not they had received defective implants or not. To ensure patients are aware of which device they have, the committee has introduced a Unique Device Identification (UDI) system which will “make it much easier to trace patients if there’s a problem and patients will also be given an implant card with the UDI, which they can use to access information via a publically accessible database,” Willmott added.

New laws will also be applied to in vitro diagnostic medical devices, which are not in direct contact with patient, but provide information on a person’s health such as blood test devices, and pregnancy. Ethical requirements have been made over DNA testing with legislation to require EU member states to inform patients of the consequences of DNA tests.

The Committee’s agreement includes; random inspections of producers’ facilities after devices have been placed on the market, stricter controls on notified bodies, which will have to employ medically skilled people, an additional safety checking procedure for high risk devices, such as implants or HIV-tests. Not only a notified body, but also a special committee of experts will check that all requirements are met, an "implant card" for patients, enabling patients and doctors to track which product has been implanted, and clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk devices.

The European Commission published the proposal in 2012 and the European Parliament agreed its position in 2014. However negotiations with MEPs could only start after they agreed their position last autumn. The reports will be put to a vote by the full House in 2017.

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Tim Annett, product liability expert at Irwin Mitchell, said:

Expert Opinion

“We welcome the decision to impose tighter regulations on medical devices and to improve the safety checks carried out by notified bodies, although it is unfortunate that it has taken this long for agreement to be reached.

“Cases such as the PIP scandal have raised some important questions about the role of notified bodies so the proposal for additional safety checks for higher risk medical devices is particularly welcome. The proposed new legislation also means manufacturers will have to provide clinical evidence of medical device safety, as they currently do for drugs.”

“The creation of an implant card and a public database, along with tighter regulations on devices will help to create transparency for patients and ultimately make procedures and devices safer.”



Tim Annett - Partner