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04.05.2020 - Cosmetics

Postponement of the entry into force of the new EU Medical Device Regulation (MDR)

Postponement of the entry into force of the new EU Medical Device Regulation (MDR)

Another step towards postponing the requirements of the new Medical Device Regulation has been taken.

The new Medical Device Regulation MDR (EU) 2017/745 was published on May 5, 2017. After a transition period of three years, it was supposed to take full effect on May 26, 2020.

Due to the increased pressure on the medical device industry from combating COVID-19, there were increasing calls for postponing the application of the new regulation. In response, the EU Commission proposed delaying the implementation by one year, to May 26, 2021. This proposal has now been adopted by the European Parliament. Now only the member states need to approve the proposal, and the postponement must be published in the Official Journal. This is expected to occur before May 26, 2020.

This gives the affected companies a bit more time to work on the approval or reapproval of their products.

For further information, please visit, among others www.europarl.europa.eu.

The BAV Institute, as an accredited testing laboratory, conducts all necessary microbiological examinations of medical devices quickly and reliably for you.

Contact us, we look forward to your message.