The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) were published on May 5, 2017 in the Official Journal of the EU. The MDR will apply from May 26, 2020. The IVDR will apply from May 26, 2022.
The new regime marks a major overhaul of the medical devices landscape that will resonate across the EU and beyond. It is, in part, a response to scandals surrounding PIP breast implants, metal-on-metal hip replacements and pacemakers, which highlighted weaknesses and gaps in the existing system. The MDR and IVDR aim to fill these gaps and to establish a more robust, transparent, predictable and sustainable regulatory framework to ensure a higher level of safety. The impact of the new regime will be felt by every medical device company operating in the EU, but the intensity will depend on the risk profile of the devices in its portfolio and, in particular, on the need to do new clinical studies. Manufacturers that have not yet carried out a gap analysis of their systems, product portfolio and Notified Body availability should start now. All stakeholders will have to deal with moving targets, given that over 80 delegated and implementing acts must still be drafted and published by the European Commission.
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