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 will 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.
Date of application of the Medical Devices Regulation postponed until May 2021.
On 26 May 2021, the Medical Device Regulation will become fully applicable, following the transition period. Please keep the revised deadline firmly in mind.
The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) remains in May 2022.
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.