in December 2021, the German Institute for Standardisation (DIN) published the new edition of DIN EN ISO 13485. The standard DIN EN ISO 13485:2021 contains requirements for a...
In the new position paper MDCG 2022-11, which has been published by the European Commission, manufacturers are requested to submit their applications for certification under MDR early and completely. ...
By Regulation (EU) 2022/112, the EU has amended the transition provisions for certain in-vitro diagnostic medical devices and postponed the date of application for „in-house devices” to 26 May 2028....
Just in time with respect to the date of application of the third generation of the Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485...
As of 2021-05-26, Directive 93/42/EEC on medical devices (hereinafter MDD) was withdrawn and thus became invalid. Consequently, according to Article 120 (1) of Regulation (EU)...
On 14.10.2021, the EU Commission published a proposal for the extension of transitional periods for the IVDR. According to this proposal, the start of application on 26.05.2022 is to remain, but...
The implementation of the EUDAMED database continues to make good progress, and existing specifications are being further elaborated and adapted accordingly.
