EAR services for medical devices and in-vitro diagnostics
The Medical Device Regulations (MDR — Regulation (EU) 2017/745 & IVDR — Regulation (EU) 2017/746) require the designation of an Authorised Representative (EAR) for legal manufacturers based outside the European Union. The legal requirements are described in Article 11 of both regulations.
We have held the European Authorised Representative role since 1995 — with EUDAMED SRN DE-AR-000000085 live for verification and EN ISO 13485:2016 certification (TÜV Rheinland Cert. SX 1546485-1). One mandate signed with our St. Ingbert office covers all 27 EU Member States.
Our EAR services include
Eight core obligations under MDR / IVDR Article 11 — covered end-to-end.
European address
Provision of an authorised European address for your medical device or IVD on the EU market.
Documentation review
Verification of EU declaration of conformity, technical documentation and the appropriate conformity assessment procedure.
Document custodian
Keeping available a copy of technical documentation, EU DoC and notified-body certificates — including amendments and supplements.
Registration compliance
Verification of compliance with all registration obligations — both for the EAR and the manufacturer.
Authority liaison
Direct interaction with EU competent authorities on your behalf throughout the device lifecycle.
Vigilance liaison
Coordinating between competent authorities, manufacturer, importer and distributor on vigilance matters.
Corrective actions
Cooperation with authorities on any preventive or corrective action to eliminate or mitigate device risk.
Incident reporting
Information of the manufacturer about complaints and reports from healthcare professionals, patients and users.
Every client gets a dedicated, secure document portal where technical files, EU Declarations of Conformity and vigilance records stay accessible to both sides of the mandate. The EAR relationship does not constrain your EU distribution strategy — you remain free to add or change distributors at any time.
Your questions about EU representation
For non-EU manufacturers, MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) require designation of an Authorised Representative established in the European Union. The EAR is your legal counterpart to the EU Competent Authorities and shares regulatory responsibility for placing your device on the EU market — defined in Article 11 of both regulations.
Any manufacturer headquartered outside the EU / EEA who places medical devices or in-vitro diagnostics on the European market — across all device classes (I, IIa, IIb, III under MDR; A, B, C, D under IVDR), including custom-made and investigational devices.
Verifying the EU Declaration of Conformity and technical documentation, registering the manufacturer and devices with EUDAMED, keeping a copy of the technical file available for Competent Authorities, cooperating on vigilance and corrective actions, and terminating the mandate if the manufacturer becomes non-compliant. We cover all eight obligations of MDR / IVDR Article 11 end-to-end.
Yes. MT Promedt acts as both EU Authorised Representative (Germany, EUDAMED SRN: DE-AR-000000085) and UK Responsible Person (UKRP) under MHRA, so you can cover EU and UK market access through a single contractual relationship.
A signed Authorised Representative mandate, your EU Declaration of Conformity, the technical documentation per Annex II / III of MDR or IVDR, your ISO 13485 certificate (where applicable), and your company and device data for EUDAMED registration.
After we review your technical documentation and you sign the written mandate, the registration process is typically initiated within a few business days. Full EUDAMED actor registration with SRN allocation depends on the German Competent Authority's processing time.
Download our EAR folders & EU regulations
EAR Folders
EAR Folder
EAR Folder
EAR Folder
EU Regulations
MDR 2017/745 — Medical Devices
IVDR 2017/746 — In Vitro Diagnostics
Need an EU Authorised Representative?
Get a tailored quote within 24 hours and start your MDR / IVDR market access with a partner who has been representing manufacturers in Europe since 1995.