EU MDR/IVDR The Medical Device Coordination Group (MDCG) has published a template of the post-market clinical follow-up (PMCF) plan to be used by medical device manufacturers to place their devices on the EU market. Due to the legal nature of the document, the provisions stated...
EU MDR/IVDR The Medical Devices Coordination Group (MDCG) has published special guidance providing medical device manufacturers and other parties involved with additional recommendations and clarifications regarding how Article 15 of the Medical Device Regulation 2017/745 (MDR)...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation 2017/745...
MDCG The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a template of the clinical evaluation report, accompanied by guidance intended to provide device manufacturers and other parties involved with the additional...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
MDCG The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on the improvement of the medical devices` regulatory framework, published regulatory requirements for ventilators and related accessories. Regulatory Background ...
