European Commission adopts new regulations on medical and in-vitro diagnostic medical devices

The European Commission welcomed the adoption of its proposal for the new Regulations on medical and in-vitro diagnostic medical devices, which will result in a number of improvements.

It said ‘the new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art.

The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.’

TOPRA is committed to providing medical devices regulatory professionals with the support they need to implement the new regulations, especially during the transitional periods. As such TOPRA is organising a one-day workshop on 22 May in Brussels, which will explore the strategic implications with speakers from the EU Commission, the Dutch device ministry, the German Federal Ministry of Health, competent authorities, notified bodies, lawyers and industry.

TOPRA also offers a wide range of continuing professional development opportunities for medical devices regulatory professionals, including a Medical Devices Regulatory Introductory Course, the Medical Devices Symposium, and for members participation in the Medical Devices Special Interest Group and relevant articles in Regulatory Rapporteur.

European Commission Press Release

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