EU MDR/IVDR The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance dedicated to the new regulations that will take effect from January 1, 2021. Starting from the aforementioned date, the authority would be fully responsible for all...
EU MDR/IVDR The Medical Device Coordination Group (MDCG) has published a Q&A dedicated to conformity assessment procedures for protective equipment. The document has been developed to provide the manufacturers and other parties involved with additional information to achieve...
EU MDR/IVDR The European Commission (EC), a legislative body of the European Union, has adopted a regulation dedicated to the common specifications for the reprocessing of single-use devices. Regulatory Background The new Commission Implementing Regulation (EU) 2020/1207 is...
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 issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to...
Europe MedTech Europe, a European association of medical device manufacturers and other industry representatives, has published a call to action related to the virtual inspections of the manufacturing facilities. Virtual Audits: Regulatory Background First of all, it is...
