MDCG The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework for medical devices, has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). The...
EU MDR/IVDR The Ministry of Healthcare of Peru has published new guidance dedicated to the validation of medical devices intended to be used in the context of the outbreak COVID-19. Regulatory Background According to the document, medical devices (including ones intended for in...
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...
