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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.

Parliament’s amendments would strengthen the procedure for placing new medical devices on the market so as to ensure that unsafe products or devices that have undergone insufficient controlled trials on patients can no longer be used on or in them.

In future, MEPs say, notified bodies should have a permanent team of in-house experts who meet up-to-date qualification requirements. A new group of bodies should assess devices considered “high risk”, for instance, devices that can be implanted in the human body.

In the wake of recent scandals, patients wearing implants would also receive an "implant card" and be registered, so that they can be alerted if any incidents are reported with a similar product.

In separate legislation, MEPs reinforced patient safety for medical diagnostic devices used, for example, to perform pregnancy tests, diabetes self-tests, and HIV and DNA tests. Parliament called for an ethics committee to be set up and introduced provisions to require the informed consent of patients to testing protocols and genetic counselling.

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