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.
This service is 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.
What the role will cover, once live
- Verifying that your EU declaration of conformity and technical documentation have been drawn up and that the appropriate conformity assessment has been carried out.
- Keeping your technical documentation, EU declaration of conformity and certificates available to competent authorities.
- Meeting our own EUDAMED registration obligations and verifying that you have met yours.
- Providing competent authorities with the information and documentation they request to demonstrate conformity.
- Forwarding authority requests for samples or device access to you, and verifying the authority receives them.
- Cooperating with competent authorities on preventive or corrective action.
- Informing you immediately of complaints and suspected-incident reports we receive.
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.
Already have an AR?
Changing Authorised Representative is regulated by Article 12 of the MDR and needs an agreement between you, your current AR and the new one. Our guide explains how it works.
Read the switching guide →Keep me informed
Leave your details and we’ll tell you as soon as the service opens for mandates. No obligation, and we won’t suggest a mandate can be signed before then.
An importer is the EU-established operator that places a device from a non-EU manufacturer on the Union market. Before that happens, someone has to check that the device is ready to cross the threshold. We do that checking, and we keep the records that prove it.
How the importer role works →