Find an EU Authorized Representative for IVD Devices

Who needs an IVDR EU Authorized Representative?

Any manufacturer of in-vitro diagnostic medical devices established outside the European Union must designate an EU Authorized Representative before placing IVD products on the EU market. This obligation applies under Article 11 of IVDR 2017/746 regardless of device class — even Class A laboratory devices require an EC REP if the manufacturer is non-EU.

IVDR Class	NB required?	Transition deadline
Class A (laboratory)	No	Already applicable
Class A (self-test)	Yes	Already applicable
Class B	Yes	26 May 2027
Class C	Yes	26 May 2026
Class D	Yes	26 May 2025

What are the IVDR transition deadlines?

IVDR became fully applicable on 26 May 2022, but the EU introduced staggered transition periods to give manufacturers time to complete conformity assessment. Deadlines differ by device class: Class D was due by 26 May 2025, Class C by 26 May 2026, and Class B and Class A sterile by 26 May 2027. Legacy IVD devices placed on the market under IVD Directive 98/79/EC must meet full IVDR requirements by their applicable transition deadline.

What does an IVDR Authorized Representative do?

• Register the manufacturer and devices in EUDAMED on behalf of the non-EU manufacturer
• Maintain a copy of the EU Declaration of Conformity and technical documentation
• Act as the primary point of contact for EU competent authorities and Notified Body audits
• Cooperate on vigilance reporting, field safety corrective actions, and recalls
• Bear joint liability with the manufacturer for non-compliant devices placed on the EU market

How is IVDR EC REP different from MDR EC REP?

The legal structure of the EC REP role is identical under MDR 2017/745 and IVDR 2017/746 — both are established under Article 11 of their respective regulations with the same mandate, joint liability, and EUDAMED registration requirements. The key differences are IVDR-specific: IVD-designated Notified Bodies are distinct from MDR-designated NBs, the conformity assessment route uses performance evaluation rather than clinical evaluation, and EUDAMED registration covers IVD-specific device identifiers. Many EC REP providers are designated to cover both MDR and IVDR under the same service contract.

Does an IVD manufacturer need a Notified Body?

It depends on device class. Class A laboratory devices do not require Notified Body involvement — the manufacturer can self-declare conformity. All other IVDR classes (Class A self-test, Class B, Class C, and Class D) require a designated Notified Body for conformity assessment. If you need both an EC REP and a Notified Body, ECP can match you to both with a single request.

How to appoint an IVDR Authorized Representative

1. Confirm your IVD class under IVDR Annex VIII — classification determines NB requirement and transition deadline.
2. Check the applicable transition deadline — Class D is already past due; Class C and B have approaching deadlines.
3. Submit a request to ECP — describe your IVD product, device class, current documentation status, and target markets to receive proposals from EC REP providers with IVDR expertise.
4. Sign mandate agreement and update technical documentation — the EC REP mandate must be signed before EUDAMED registration and must be reflected in labelling and technical files.