Insights
The EU market-access briefing room.
Practical notes on importer and Authorised Representative obligations, EUDAMED, and what changes for manufacturers selling into the EU.
EUDAMED registration: what has to be done by 28 November 2026
Four EUDAMED modules became mandatory on 28 May 2026. Here is what that means for devices already on the market, for new devices, and for the importer and Authorised Representative in your supply chain.
Read →Authorised Representative, importer, distributor: who does what under the MDR
Three economic-operator roles that non-EU manufacturers often confuse. What each one is, what the MDR requires of it, and whether one company can hold more than one.
Read →Changing your EU Authorised Representative: how Article 12 works in practice
Many non-EU manufacturers appointed an EU Authorised Representative in a hurry and have never reviewed it. Switching is regulated, but manageable. Here is what the agreement must cover and the practical steps around it.
Read →