Coming soon
EU Authorised Representative
If you manufacture a medical device outside the EU and want to place it on the Union market, you need an Authorised Representative established in the EU. MD QMS SRL is bringing this service online — it is in development and not yet open for mandates.
What an Authorised Representative is
The Authorised Representative is the manufacturer’s legal presence inside the EU, identified on your documentation and acting as the point of contact between your company and EU competent authorities. The relationship is governed by a written mandate that sets out, precisely, the tasks you delegate and the ones you keep. We are setting up this service now, ahead of accepting mandates.
What the role will cover, once live
- Acting as your named EU point of contact for competent authorities.
- Holding and making available the technical documentation we are mandated to keep available.
- Cooperating with authorities on any preventive or corrective action concerning your devices.
- Forwarding requests for samples, information, or access that authorities direct to us.
- Maintaining our registration as an economic operator in EUDAMED in connection with your devices.
What stays with you
An Authorised Representative is not a substitute for the manufacturer’s own responsibilities. Conformity assessment, technical documentation, clinical evaluation and the decision to place a device on the market remain yours. We’re explicit about this boundary now, ahead of launch, because a representative who blurs it later is a liability, not a safeguard.
Who this will be for
Manufacturers based outside the EU — including UK manufacturers since Brexit — who need a compliant EU-based representative to access the Single Market under the MDR. If that’s you, we can let you know as soon as the service opens.