Canada Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
Canada Health Canada, the country’s regulating authority in the sphere of medical devices, has published a detailed guidance document describing the rules to be applied when determining the class of an in vitro diagnostic medical device (IVDD). The document provides an...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a Q&A document dedicated to the regulatory requirements for registration in EUDAMED, the new EU-wide database, of actors other...
Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper describing proposed changes to the regulation of personalized medical devices. As mentioned in our previous article...
EU MDR/IVDR The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal Status The new framework introduced by these...
