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Public Health

Getting ready for the new regulations

The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science and progress in law-making.

The new regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.

Unlike directives, regulations do not need to be transposed into national law. The MDR and the IVDR will therefore limit discrepancies in interpretation across the EU market.

The MDR is fully applicable since 26 May 2021 and the IVDR since 26 May 2022, following the transition periods.

If you manufacture, distribute or procure medical devices, or have other responsibilities under the new Regulations, please take advantage of the delay by making absolutely sure that you will be ready for the new deadline.

What is your area of activity?

Dedicated factsheets provide a summarised view of the main areas of activities in the medical devices sector.

Manufacturers of medical devicesManufacturers of in vitro diagnostic medical devices
Authorised representatives, importers and distributersManufacturers of devices without an intended medical purpose
Healthcare professionals and health institutionsCompetent authorities in non-EU/EEA countries
Health institutions reprocessing single-use devicesThe Procurement of MDS and IVDS