On 3 April 2020, the proposal of the day of the implementation of the new MDR has been published.

In the proposal, all dates referring to the original implementation date of 26 May 2020 have been replaced by 26 May 2021, with exception of the preparation of the guidelines on phthalates. In addition to keeping the requirements for existing devices, this allows placing new or modified medical devices on the market under the Directives 93/42/EEC and 90/385/EEC up to this new implementation date next year. The deadlines for placing the UDI on the device and packaging, which were scheduled further in the future, remain unchanged.

The proposal also suggests implementing Article 59 of the MDR (EU) 2017/745 prematurely, which allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the EU. The national derogations in Article 59 are intended to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health.

At this moment, the delay of the MDR (EU) 2017/745 implementation is only a proposal by the European Commission, and has not yet been adopted by the European Parliament. We will keep you informed about further development.