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 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 European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a detailed FAQ dedicated to the most important questions related to the Unique Device Identification (UDI) system established under the Medical Device Regulation...
