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As of 2021-05-26, Directive 93/42/EEC on medical devices (hereinafter MDD) was withdrawn and thus became invalid.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.
The Competent Authority for medical devices in Taiwan TFDA has extended the transition period for the application of the new „Technical Cooperation Programme“ for an abbreviated market access to...
Please note the document structure updated by us in January 2020 for the submission of Technical Documentation under Directive 93/42/EEC (MDD) and (EU) 2017/745 (MDR) and the associated empty...