What happens if our AR resigns or terminates the contract?

You must appoint a new AR before the existing AR relationship terminates — devices cannot legally be sold in the EU without an active AR. We provide 90 days' written notice of any contract termination to allow you adequate time to transition.

Does the AR need to be located in a specific EU country?

No — the AR can be established anywhere in the EU or EEA. MEGACERT's AR registration is based within the EU, covering all 27 member states.

MDR Article 11

EU Authorized Representative — Your Legal Gateway to the European Market

If your company is based outside the European Union and you want to sell medical devices in Europe, you are legally required to appoint an EU Authorized Representative under MDR Article 11. MEGACERT acts as your AR — registering your devices, managing regulatory communications, and ensuring you remain compliant year-round.

Learn About Our AR Services →

Who Needs an EU Authorized Representative?

Under EU MDR 2017/745 Article 11, any manufacturer established outside the European Union (including UK post-Brexit, Turkey, USA, Japan, China, and all other non-EU countries) must appoint an Authorized Representative (AR) before their medical device can bear the CE mark and be placed on the EU market.

The AR is not a distributor or agent — it is a legally designated entity with specific responsibilities defined in MDR Article 11(3):

Registering the manufacturer and devices in EUDAMED
Verifying that Declaration of Conformity and Technical Documentation are in place
Forwarding complaints and Field Safety Corrective Actions to the manufacturer
Cooperating with National Competent Authorities (NCAs) on request
Being the regulatory point of contact for EU authorities

Critical: The AR's name and address must appear on the device label alongside the manufacturer's address.

MEGACERT Authorized Representative Services

EUDAMED Registration

We register your company as manufacturer and register each of your devices in EUDAMED (European Database on Medical Devices) — including UDI-DI/PI assignment, device classification, and NB reference data.

Declaration of Conformity (DoC) Co-Signing

As your AR, MEGACERT co-signs your Declaration of Conformity as required by MDR Annex IV, accepting shared regulatory responsibility.

Labelling Review

We review your device labelling to ensure the AR's address and the EU MDR symbol (EC REP) are correctly applied per MDR Annex I Chapter III.

Vigilance & Incident Management

We receive, log, and forward serious incident reports and FSCAs to you, and where required, report to NCAs within MDR timeframes (2 days for serious public health threats / 10 days for death or serious deterioration).

NCA Liaison

We act as the single point of contact for all National Competent Authority inquiries, market surveillance investigations, and inspection notifications across all 27 EU member states.

Annual Compliance Review

We conduct an annual review of your MDR compliance status — checking UDI system updates, EUDAMED record accuracy, PMSR/PSUR submission status, and Technical Documentation currency.

Our AR Service Tiers

Service	Essentials	Professional	Enterprise
EUDAMED registration	✓	✓	✓
DoC co-signing	✓	✓	✓
Labelling review	—	✓	✓
Vigilance management	—	✓	✓
NCA liaison	—	✓	✓
Annual compliance review	—	—	✓
Number of devices	1–3	Up to 15	Unlimited

Frequently Asked Questions

Yes. Turkish manufacturers are among the most frequent users of EU AR services, as Turkey is not an EU member state. We have extensive experience supporting Turkish medical device companies entering the EU market. Our UNICERT entity in London also supports UK-specific UKCA requirements.

Ready to enter the EU market with a trusted Authorized Representative? Contact MEGACERT today to discuss your AR needs.