European Commission Adopts New Safety Measures for Medical Devices

October 23, 2013—The European Commission recently adopted two measures to improve the safety of medical devices. The newly adopted measures were announced on September 24 as part of the joint plan for immediate action agreed upon between the Commission and the European Union member states. An analysis of the measures was published on October 22 in The Wall Street Journal.

The European Commission advised that most of the actions agreed upon have now been implemented or are under implementation. The overall progress will be presented in a Commission Staff Working Document that is expected to be published later this month.

As summarized by the European Commission, the two measures are a Commission Implementation Regulation and a Recommendation. The first clarifies the criteria to be met by notified bodies, which are responsible for inspecting medical device manufacturers. The second clarifies the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector, which covers approximately 10,000 types of products, from plasters to pacemakers. 

The joint plan focuses on the functioning of notified bodies, the surveillance by the member states of the products on the market, European Union coordinated investigations and responses to problems with specific devices, as well as improved transparency and communication between member states, industry, health care professionals, and notified bodies.

The European Commission stated that these measures demonstrate its commitment to restore patient confidence in the medical devices sector following the Poly Implant Prothèse (PIP; La Seyne-sur-Mer, France) breast implants scandal and other incidents. PIP, which was dissolved in 2011, suspended the marketing of its breast implants in March 2010 after regulators found that the company's implants contained industrial silicone rather than approved medical-grade fillers, which may been more prone to rupture and leakage than other implants. The PIP scandal and subsequent investigations were summarized in a June 2012 advisory from the UK National Health Service.

In addition to these measures, a pilot project of joint audits of notified bodies undertaken by auditors from several member states and the commission was launched earlier this year. Eleven such audits have taken place. Eight additional audits are planned before the end of the year. Before the adoption of the new measures, these actions have resulted in two notified bodies being obliged to temporarily stop issuing certificates until deficiencies have been corrected.

As outlined by the European Commission, strengthened requirements in the new measures include the following: 

• A Member State shall only designate a notified body after a joint assessment conducted with experts from the commission and other member states. The assessment reports shall be made available to all other member states. 
• Member states are required to carry out surveillance and monitoring of the notified bodies at certain intervals to ensure that they continuously live up to the requirements. If this is not the case, the member state must withdraw the designation as a notified body. 
• Knowledge and experience requirements of the staff of the notified bodies to be required by member states are clarified. 
• It is now required that notified bodies shall randomly perform unannounced factory audits and, in this context, check adequate samples from the production. Failure to carry out random checks will result in the suspension or withdrawal of the designation of the notified body. 
• Where risks might be caused by the substitution or adulteration of raw materials, such as in the PIP case, a notified body shall also check that the quantity of finished products corresponds to the quantity of the crucial raw material purchased.

Notified bodies are independent public or private third-party organizations or companies designated by the member states to carry out control of manufacturers of medium- and high-risk medical devices. A control made in one member state is valid for the entire European Union. There are approximately 80 notified bodies for medical devices in the European Union.

In the September 24 announcement, European Union Commissioner for Consumer Policy Neven Mimica commented, “With today's measures, the European Commission further strengthens the safety of medical devices. We now have a clearer basis for unannounced audits, sample testing, or joint assessments by notified bodies. Full clarity can only be achieved through amending the basic legislation. I am committed to support the Parliament and the Council with a view to completing the on-going revision by early next year.”