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...
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...
The Regulation (EU) 2017/745 (MDR) describes in Article 87 for all manufacturers of medical devices binding requirements for the interpretation of the reporting obligations and harmonized timelines...
As of today (2021-05-26), Regulation (EU) 2017/745 on medical devices (MDR) represents the applicable legal framework for medical devices. This is supplemented by national laws (e.g. in Germany the...
As of 2021-05-26, the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) are history. These two directives are replaced by the European...
