Critical Catalyst

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the European Union market if the manufacturer designates an Authorised Representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both and , but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

https://criticalcatalyst.com/roles-and-responsibilities-of-an-authorised-representative-under-eu-mdr-and-ivdr/

The European Commission just proposed a set of amendments aimed to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new and framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device - until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

https://criticalcatalyst.com/amendments-to-the-transitional-provisions-of-the-european-union-mdr-and-ivdr/