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Compliance and traceability of medical devices – developments

Moves to improve the compliance and traceability of medical devices took a step forward this week, when MEPs approved at first reading proposals to ensure stricter monitoring and certification procedures.

Issues surrounding medical devices have been in the spotlight over recent years, following scandals over breast and hip implants.

The proposed legislation seeks to increase patient safety and to strengthen traceability from producer to patient, without creating additional burdens for innovative small manufacturers.

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EC calls for immediate action on medical devices

European Health and Consumer Policy Commissioner John Dalli has called on Member States for immediate action to be taken at national level to ensure full and stringent implementation of the current legislation on medical devices.

Following the discovery of the use of non medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company in France, the priority now is for the Member States and the Commission to act together to tighten controls, provide a better guarantee of the safety of medical devices and to restore patient confidence in the law that protects them.

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 high risk devices. The actions proposed include the following:

  • 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 analysing 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.

 

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