EU Medical Device Regulation (MDR): where do we stand at present?
The EU-MDR (Medical Device Regulation) came into force in May 2017.
This stipulates that as from 26 May 2021*), new products and those without a valid CE certificate according to the MDD Directive (Medical Device Directive) must fully meet the requirements of the MDR.
A transitional regulation according to MDR Article 120 allows manufacturers to continue marketing (up to 2025 maximum) medical devices (except Class I) with CE conformity according to the valid MDD certificate.
We are prepared so that the supplies to our customers are guaranteed and there will be no delivery bottlenecks. The requirements of the MDR have been taken into account in the revision of our QM processes. The changeover is already in full progress and will be completed on time.
Answers to your questions concerning the MDR can be found in our Customer information under Downloads on the Quality Policy page.
*) The date has been postponed by one year from 26 May 2020 to 26 May 2021 due to the corona pandemic.