What is the difference between a Notified Body and an EU Authorized Representative?

A Notified Body (NB) audits medical devices and issues CE certificates. An EU Authorized Representative (EC REP) is a legal entity in the EU that acts on behalf of a non-EU manufacturer for regulatory purposes. The NB certifies the device; the EC REP represents the manufacturer. They are separate roles and often different organisations.

Do I need both a Notified Body and an EU Authorized Representative?

If you are a non-EU manufacturer with a Class IIa, IIb or III device, you need both: an NB to certify the device and an EC REP to represent you in the EU. For Class I non-sterile, non-measuring devices you need an EC REP but not an NB.

Who appoints the Notified Body and the EC REP?

The manufacturer selects and contracts both. The NB is selected based on its designation scope. The EC REP is selected based on EU establishment, experience, and service offering. Both must be contractually appointed before placing devices on the EU market.

EU MDR Compliance Guide

Notified Body vs EU Authorized Representative

Q: Can a Notified Body also act as an EU Authorized Representative?

No. This is prohibited under MDR 2017/745. A Notified Body that certifies a device cannot also act as the EU Authorized Representative for that same device. The two roles must always be held by separate, independent entities.

Two mandatory roles under MDR 2017/745 that are often confused — but serve completely different functions. This page explains what each does, when you need which, and when you need both.

Do I need an NB? →

In one sentence A Notified Body certifies your device. An EU Authorized Representative represents your company in the EU. They are separate roles, often different organisations, and both may be required simultaneously.

Side-by-side comparison

Factor	Notified Body (NB)	EU Authorized Representative (EC REP)
Primary role	Audits device and QMS; issues CE certificate	Legal contact for EU authorities on behalf of manufacturer
Legal basis	MDR 2017/745, Articles 36–50; Annexes IX–XI	MDR 2017/745, Article 11
Designated by	EU Member State authority	Manufacturer (written mandate)
Must be located	In an EU Member State	Established in an EU Member State
Output	EU certificate of conformity	Mandate; EUDAMED SRN registration
Liability	Liable for incorrect conformity assessment	Jointly liable with manufacturer for non-compliant devices
Required for Class I?	No (except sterile/measuring/reusable surgical)	Yes — all classes if manufacturer is outside EU
Required for Class IIa–III?	Yes — mandatory	Yes — if manufacturer is outside EU
Same entity for both?	Prohibited — conflict of interest under MDR

When do you need each?

Situation	NB needed?	EC REP needed?
Non-EU manufacturer, Class I standard	No	Yes
Non-EU manufacturer, Class I sterile or measuring	Yes (partial)	Yes
Non-EU manufacturer, Class IIa	Yes	Yes
Non-EU manufacturer, Class IIb or III	Yes	Yes
EU manufacturer, any class	Depends on class	No
Non-EU IVD manufacturer, IVDR Class A lab	No	Yes
Non-EU IVD manufacturer, IVDR Class B–D	Yes	Yes

What does a Notified Body do?

A Notified Body performs the conformity assessment of the medical device itself. Under MDR, this involves auditing the manufacturer quality management system, reviewing technical documentation, and for higher-risk devices, examining the design dossier. The NB issues the EU certificate that is a prerequisite for CE marking for Class IIa, IIb, and III devices.

Notified Bodies are designated by EU Member States and listed in EUDAMED and the NANDO database. Each NB has a specific designation scope — not all NBs cover all device types. Finding an NB with the right scope and current capacity is the primary challenge for manufacturers in 2026.

NB capacity crisis 2026 MDR NB capacity remains severely constrained. Over 33,000 MDR applications were submitted in 2024 against roughly 17,500 certificates issued. Most Class III NBs have 18–24 month waitlists. Start NB selection early.

What does an EU Authorized Representative do?

An EU Authorized Representative (EC REP) is a legal entity established in an EU Member State that the non-EU manufacturer designates by written mandate. The EC REP name and EU address must appear on the device label and in EUDAMED. The EC REP is the point of contact for EU competent authorities and market surveillance bodies.

Under MDR Article 11(3), the EC REP can be held jointly and severally liable for non-compliant devices — which is why reputable EC REP providers carry professional indemnity and product liability insurance. The EC REP also handles EUDAMED registration and serious incident reporting obligations.

The three key differences

Function: The NB certifies the product. The EC REP represents the manufacturer. Fundamentally different roles.
Trigger: NB is triggered by device class (IIa and above). EC REP is triggered by manufacturer location (non-EU).
Prohibition: The same entity cannot hold both roles for the same device. MDR requires independence between them.

Can a Notified Body also act as EC REP?

No. Explicitly prohibited under MDR. A Notified Body that certifies a device cannot also act as the EU Authorized Representative for that device — it creates a structural conflict of interest between the auditor and the legal representative. The roles must always be held by separate, independent entities.

Do I need to appoint the NB or the EC REP first?

Appoint the EC REP first for EUDAMED registration — you need an SRN before the NB can link your device to EUDAMED. In practice, NB selection runs in parallel since NB procurement takes significantly longer. Expect 6–24 months for NB certification depending on device class; EC REP appointment typically takes 1–3 weeks.

What about UK and Swiss equivalents?

Post-Brexit, the UK requires a separate UK Responsible Person (UKRP) under UK MDR 2002. Switzerland requires a separate Swiss Authorized Representative (CH REP) under MepV. These are distinct from the EU EC REP and require separate appointments. Some EC REP providers offer all three through affiliated entities under one contract.

Find an NB or EC REP through ECP

ECP connects non-EU manufacturers with Notified Bodies and EU Authorized Representatives through one structured request. Submit once and receive proposals from relevant providers for both roles simultaneously.

Find a Notified Body

Filter by class: IIa, IIb, III, IVD

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EC REP for MDR, IVDR, and GPSR

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Pricing models, coverage, PRRC

NB availability tracker 2026

Which NBs are accepting applications

Do I need an NB?

MDR and IVDR class decision tool

MDR conformity assessment routes

Annex IX, X, XI by device class

Find both an NB and an EC REP through ECP

Submit one request — ECP routes it to relevant Notified Bodies and EC REP providers simultaneously. Free, no commitment.