Do You Need a Notified Body? The Article 52 Answer, Class by Class

A notified body is the single largest line in most EU market-entry budgets and the single longest lead time. Whether you need one is decided entirely by your device's class, and the answer is written in one article. Whether you can get one is a different question, and it is worth understanding both before you plan a launch.

The rule

Article 52(1) of Regulation (EU) 2017/745 requires manufacturers, prior to placing a device on the market, to undertake an assessment of conformity in accordance with the applicable procedures set out in Annexes IX to XI. Which procedure applies is a function of class.

Class I — no notified body. Article 52(7) lets the manufacturer declare conformity after drawing up the technical documentation of Annexes II and III. The self-certification route covers this in detail.

Class Is, Im, Ir — a notified body, with a limited remit. Sterile condition, measuring function or reusable surgical instrument. The Regulation confines the assessment to that one aspect: sterility, metrology, or reuse. Everything else remains self-assessed.

Class IIa — a notified body. Either Annex IX Chapters I and III, including assessment of the technical documentation of at least one representative device for each category of devices; or Annex XI Part A or Part B combined with technical documentation assessment on the same sampling basis.

Class IIb — a notified body. Annex IX Chapters I and III including technical documentation assessment for at least one representative device per generic device group; or Annex X type-examination combined with Annex XI. For implantable class IIb devices the sampling concession narrows sharply: the technical documentation is assessed for every device, with an exception for well-established technologies — sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

Class III — a notified body. Annex IX Chapters I and III, or Annex X type-examination combined with Annex XI Part A. Class III implantable devices and certain class IIb active devices intended to administer or remove a medicinal product additionally go through the clinical evaluation consultation procedure of Article 54, in which an expert panel may deliver a scientific opinion.

Two things follow. First, the difference between class IIa and class IIb is not "more paperwork" — it is a different sampling depth on your technical documentation, which changes both the fee and the timeline. Second, the classification decision under Annex VIII is the most consequential regulatory decision you make, and it deserves more scrutiny than it usually gets. Our note on classification works through the rules.

Choosing one

Article 53(1) is the provision that governs the choice:

"Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for the conformity assessment activities, the conformity assessment procedures and the devices concerned. An application for the same conformity assessment activity may not be lodged concurrently with more than one notified body."

Read the two halves separately.

The first half is a scope question, and it is checkable before you make contact. Notified bodies are designated for specific codes, not for the MDR at large. The codes are set out in Commission Implementing Regulation (EU) 2017/2185, and the designation of every body — with its identification number and its full scope — is published in the Commission's NANDO database. A body designated for MDA codes covering active devices is not thereby designated for your implantable. Checking NANDO takes ten minutes and saves months.

The second half is a rule most first-time manufacturers do not know: you may not shop the same conformity assessment activity around two bodies at once. You can talk to several. You can apply to one.

Practical questions worth asking before you sign: is the body designated for your specific codes, does it accept applications in your device area at present, what is its position on your device's classification, and what happens to your file if the body's designation changes. A body that will not discuss classification before an application is not being rigorous; it is being unhelpful.

What a certificate is and is not

Certificates are issued under Article 56. Article 56(2) limits validity to the period indicated on the certificate, which shall not exceed five years. They can be renewed on reassessment; they can also be suspended, restricted or withdrawn.

A certificate covers what its scope says and nothing more. Three consequences that catch manufacturers out:

A quality management system certificate under Annex IX Chapter I is not a product certificate. It says your system conforms. It does not say a device in your catalogue was individually assessed — that is what the Chapter III technical documentation assessment does, on the sampling basis above.

A class Is or Im certificate covers sterility or metrology only. Presenting it to a customer as evidence that the device was assessed by a notified body is, at best, misleading.

A certificate is not a CE mark. Article 20(5) requires the notified body's four-digit identification number next to the CE mark where a notified body was involved in the applicable procedure. The number belongs to the body, appears on the device labelling, and is one of the fastest ways for a competent authority to check whether the marking matches the file.

Changing notified bodies mid-life is possible but not casual: the Regulation requires an arrangement between the outgoing and incoming bodies and defines what happens to certificates in the interim. Plan the change; do not improvise it.

The lead time nobody controls

We do not publish timelines as promises, and we would be sceptical of anyone who does. The Regulation sets no fixed processing clock for a notified body, and the practical determinants — your file's completeness, the body's capacity in your device area, and how many rounds of deficiency questions your documentation generates — are mostly on your side of the table. The one lever that reliably shortens the process is a technical file that answers Annex II in the order Annex II asks, with the general safety and performance requirements of Annex I mapped to the evidence that demonstrates each one.

What a notified body does not do for you

It does not appoint your authorised representative, register you in EUDAMED, or make you compliant with Article 11. Those are separate obligations that run in parallel and, in the case of the representative's SRN, are needed before you apply — Article 31(3) requires the manufacturer to use the SRN when applying to a notified body for conformity assessment.

That sequencing point is the single most useful thing on this page. Register the actors, obtain the SRNs, then apply. Our note on EUDAMED actor registration sets out how that step works, and the 2-minute representative test settles whether Article 11 applies to your company at all.

Medex acts as EU authorised representative for manufacturers outside the Union. We are not a notified body, we do not perform conformity assessment, and we do not take a commission on introductions — the two roles are separate under the Regulation and are best kept separate in practice. Our class-based rates are published.

How a notified body is designated, and how to check its scope

A notified body is not competent for medical devices in general. It is designated for defined conformity assessment activities and for defined device types, and that scope is published. Under Article 43(1) of MDR 2017/745, "The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11)." That four-digit number on a certificate is the body's identity across every Union act it is notified under.

The scope itself is public. Article 43(2) requires that the Commission "shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO." For a manufacturer this is the check that comes before any commercial conversation: open NANDO, find the body by its number, and confirm that the codes covering your device are actually inside its designation. A body with a long track record in orthopaedic implants is not automatically designated for your software or your sterile single-use device.

Scope is also not permanent. Article 46(1) provides that "The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body. The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation." An extension is a full assessment, not an administrative note, which is why a body may decline device types it could in principle handle: adding them to its designation is a project of its own.

What happens if your notified body stops

This is the risk manufacturers rarely price in. Article 46(3) sets out what follows when a body withdraws from the field: "Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates."

Read that condition carefully. The nine months are not automatic. They run only where another body has confirmed in writing that it will take the devices on, and that body "shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices." A manufacturer whose certificate is issued by a body under supervisory pressure is therefore carrying a second timeline alongside its own, and the practical answer is the unglamorous one: keep the technical documentation in a state where a new body could assess it without a reconstruction project.

Ongoing supervision runs in the background of all of this. Under Article 44(1) notified bodies must "without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated."

Sources (official)

Regulation (EU) 2017/745, Articles 20, 31(3), 52, 53, 54, 56 and Annexes VII, VIII, IX, X and XI

Regulation (EU) 2017/746, Article 48 and Annexes IX to XI

Commission Implementing Regulation (EU) 2017/2185 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies

European Commission — NANDO, New Approach Notified and Designated Organisations database

MDCG 2021-24 Rev.1 — Guidance on classification of medical devices

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550, verifiable in the EUDAMED public actor database. We are not a law firm and do not provide legal advice.