EU Commission Issues Statement on Medical Device Regulations following PIP Breast Implant Problem

Enews - 17 February 2012

The European Health and Consumer Policy Commissioner, John Dalli, called on EU Member States for immediate action to be taken on a national level to ensure full and stringent implementation of the current legislation on medical devices. The immediate actions include tightening of controls, increasing surveillance, and a restoration of full confidence in the EU CE Marking regulatory system.

The EU commission issued a press release indicating Commissioner Dalli has written to Member States asking for their co-operation within the existing legal framework to tighten controls in order to provide a better guarantee of the safety of medical technology, especially with high risk devices.

The proposed actions include:

Verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence.

Ensure that all notified bodies in the context of the conformity assessment make full use of their powers given to them under the current legislation which including the powers to conduct unannounced inspections.

Reinforce market surveillance by national authorities, in particular spot checks in respect of certain types of devices.

Improve the functioning of the vigilance system for medical devices for example by giving systematic access for notified bodies to reports of adverse events; encouraging healthcare professionals and empowering patients to report adverse events; enhanced coordination in analyzing reported incidents in order to pool expertise and speed up necessary corrective actions. Support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers.

Commissioner Dalli’s statements can be viewed at the EU Commission website:

As a leading EU Notified Body, BSI is monitoring these developments, engaging in the discussions, and supporting the consideration of appropriate improvements to the EU system.