EU Authorised Representative Services for MDR & IVDR

An EU Authorised Representative (EU REP) is an individual or company established in the European Union that represents a medical device manufacturer located outside the EU. The EC REP helps ensure compliance with EU MDR 2017/745 or IVDR 2017/746 requirements and acts as the official point of contact between the manufacturer and EU regulatory authorities.

Under MDR 2017/745 and IVDR 2017/746, non-EU manufacturers must appoint a single EU Authorised Representative before placing their products on the EU market. I3CGlobal provides dedicated EU Representative services to manufacturers across Asia and North America, particularly in China, India, South Korea, Japan, the USA, the UK, Vietnam, and beyond, with EUDAMED registration completed in as little as 10 working days.

EU Authorized Representative Office(s) Address

 Alsstr. 97, 41063 Mönchengladbach, Dusseldorf, Germany

 Rua Hermano Neves n° 18, Piso 3, E7 1600-477, Lisboa, Portugal

If you manufacture medical devices outside the EU and want to sell in Europe, you need an EU Representative one legal entity, based inside the EU, formally appointed before a single device crosses the border.

Article 11(1) of MDR 2017/745 requires non-EU manufacturers to designate a sole EU Representative as a condition of market access. IVDR 2017/746 Article 11(1) mirrors this requirement word for word for in-vitro diagnostic devices. For IVD manufacturers, the IVDR authorized representative carries the same legal standing and the same liability exposure under Article 11(5) of IVDR 2017/746.

The role goes well beyond a contact name. The EU Representative must keep your technical documentation and Declaration of Conformity on hand (Annex II and Annex IV, MDR/IVDR), register devices in EUDAMED, and cooperate with national authorities on recalls and corrective actions.

Under Article 11(5) of both regulations, if the manufacturer does not meet its obligations, the AR can be held jointly and severally liable for defective devices. That is a meaningful legal exposure, not a rubber stamp.

The conformity assessment records the AR must retain are governed by Annex IX (MDR and IVDR). EU authorities need someone within their jurisdiction they can audit, contact, and hold responsible. That is the whole point of the requirement.

Any manufacturer outside the EU must appoint a single European Authorized Representative before a medical device reaches the European market, a hard requirement under Article 11 of MDR 2017/745, regardless of device class.

The MDR Authorized Representative holds your Technical Documentation, EU Declaration of Conformity, and CE certificates for the period under Article 10(8), verifies Unique Device Identification and registration obligations under Articles 27, 29, and 31, and supplies conformity documentation to competent authorities in the required Member State language on request.

Operationally, they handle vigilance reporting, support field safety corrective actions, and relay adverse events from healthcare professionals or patients back to the manufacturer. They are who EU authorities call when something goes wrong, not an admin layer.

Under Article 11(5), if the manufacturer fails its Article 10 obligations, the EU Representative faces joint and several liability for defective devices. The mandate can be terminated if the manufacturer stops complying and the competent authority must be notified when that happens.

Article 11 of IVDR 2017/746 sets the same base requirement for IVD manufacturers: one IVDR authorized representative in the EU, appointed in writing, before any in-vitro diagnostic device enters the European market.

The EU Representative maintains Technical Documentation, Declaration of Conformity, and certificates under Article 10(7), verifies EUDAMED registration and UDI compliance under Articles 24, 26, and 28, and produces conformity documentation for authorities on request. Physical access to device samples is facilitated through them too.

Post-market is where IVD representatives earn their keep. Incident reports and safety communications from laboratories, clinicians, or patients go through the representative to the manufacturer as they are the first contact point during inspections and market surveillance.

Under Article 11(5) of IVDR 2017/746, the IVDR authorized representative can be held jointly and severally liable for defective IVD devices where the manufacturer has failed its obligations. Authorities must be notified when the mandate is withdrawn.

I3CGlobal serves as EU Representative services for medical device and IVD manufacturers entering the EU market under MDR 2017/745 and IVDR 2017/746. Here is exactly what that covers.

• Liaison with European National Competent Authorities and Notified Bodies
• We review your EU Declaration of Conformity and Technical Documentation against MDR or IVDR requirements. Any compliance issues will be informed
• Your latest revisions of technical documentation files stored in safe custody and produced to EU authorities when requested.
• We register your organisation and products in EUDAMED and obtain your Single Registration Number
• A qualified Person Responsible for Regulatory Compliance inside the EU, covering all regulatory duties
• Our name, address, and EC REP symbol on your packaging, labels, and IFU
• Complaints from users go to your team. Serious adverse incidents, FSCAs, and recalls go to EU authorities from us, immediately.
• We carry equal legal and financial liability for defective devices on the EU market alongside you.

I3CGLOBAL is one of the few EU Representative providers that lets you choose your registered address: Mönchengladbach, Germany or Lisbon, Portugal. Both offices carry out the full Article 11 mandate under MDR 2017/745 and IVDR 2017/746, with the same regulatory team behind them. The difference is commercial, not regulatory.

Germany – Alsstr. 97, 41063 Mönchengladbach (Düsseldorf region) Credibility and commercial reach. Best for: Class IIb/III and higher-value devices, companies building a distributor network, and brands planning to sell in Germany, Austria and Switzerland.

• A label buyers recognise. Germany is Europe’s largest medical device market. A German EC REP address tells hospital procurement teams, tender panels and Notified Bodies that you are serious about Europe.
• Distributors and dealers take notice. German and DACH distributors are generally more comfortable onboarding a non-EU brand whose representative is local to them.
• Next door to MEDICA. Our office is close to Düsseldorf, home of the MEDICA trade fair, which helps when you meet partners, importers and investors in person.
• BfArM as your reference authority. You deal with one of Europe’s most established competent authorities, and that track record reassures partners.

Portugal – Rua Hermano Neves n° 18, Piso 3, E7, 1600-477 Lisboa – Faster and more economical. Best for: Startups, Class I and IIa devices, IVDs, cost-sensitive portfolios, and manufacturers that sell through their own channels or online.

• Lower annual fee. The same MDR/IVDR mandate, SRN and EUDAMED support at a lower annual cost than our German office.
• Faster onboarding. A leaner process from mandate signing to EU REP appointment, which suits tight launch dates.
• Full EU market access. Your devices can be sold in Germany, France, Italy and every other EU/EEA market, exactly as they could with a German address.
• A link to Portuguese-speaking markets. For manufacturers in Brazil and other Lusophone markets, working with a Lisbon office makes communication and documentation easier.