SCC Newsletter 2020 - NewsFlash

REGULATORY NEWSFLASH

Date: 5 May 2020

» MEDICAL DEVICES

One year delay in the implementation dates of the Medical Device Regulation (EU) 2017/745 due to COVID-19

An amendment relating to the dates of application of the new medical device regulation MDR (EU) 2017/745, decided by the European parliament on 17 April 2020, has been published and is in force. In the amendment, all dates referring to the original implementation date of 26 May 2020 have been replaced by 26 May 2021, with exception of the preparation of the guidelines on phthalates.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.

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