You send enquiries to six notified bodies. Two never reply. One is not accepting new applications in your device area. One asks for your device codes and you are not certain what they are. One quotes double the others and cannot explain why.
That is the normal experience of a first-time CE marking applicant, and the decision matters more than the price spread suggests. Signing with a body that is not designated for your device costs months you cannot recover.
1. Check the designation codes, not the reputation
A notified body is not designated for medical devices in general, but for specific codes in Commission Implementing Regulation (EU) 2017/2185:
- MDA — active devices, by design and intended purpose
- MDN — non-active devices, by design and intended purpose
- MDS — devices with specific characteristics
- MDT — devices using specific technologies or processes
MDA and MDN are vertical codes describing your device. MDS and MDT are horizontal codes describing something about it — that it incorporates animal tissue, or is supplied sterile. A body must hold every code that applies. Holding the MDN code for your device type but not the MDT code for your sterilisation process means a refused application.
Designations are published in NANDO, the Commission’s database of notified organisations. As at 28 February 2026, 52 bodies were designated under Regulation (EU) 2017/745 and 19 under Regulation (EU) 2017/746. Check NANDO, not a body’s own website — a restricted scope appears there too.
2. Establish which Article 52 route your class forces
Article 52 decides how much work the body must do, and therefore the cost and duration. Your classification decides it, not you.
- Class III, not custom-made: Annex IX, or Annex X type-examination with Annex XI — Article 52(3).
- Class IIb, non-implantable: Annex IX Chapters I and III, with an Annex IX Section 4 assessment of the technical documentation of at least one representative device per generic device group — Article 52(4).
- Class IIb implantable: that Section 4 assessment applies to every device, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors — Article 52(4), second subparagraph.
- Class IIa: Annex IX Chapters I and III, with a Section 4 assessment of at least one representative device for each category of devices — Article 52(6).
- Class I supplied sterile, with a measuring function, or reusable surgical instruments: involvement is limited to the sterility, metrological or reuse aspects — Article 52(7). The rest you self-declare.
The difference between one representative device per generic device group and every device is the largest cost driver in a Class IIb portfolio. Settle it before requesting quotations, or you will compare figures built on different assumptions.
3. Check whether Article 54 applies
For a Class III implantable, or a Class IIb active device intended to administer or remove a medicinal product, the clinical evaluation consultation procedure applies. Under Article 54(1) read with Annex IX Section 5.1, the body’s assessment report goes to an expert panel under Article 106: a screening panel has 21 days to decide whether a scientific opinion is needed, and if so the panel has a further 39 days. That is at least 60 days on your critical path. The opinion is not binding, but the body must give it due consideration.
4. Read the published fee list before asking for a quotation
Article 50 requires every notified body to publish a list of its standard fees. MDCG 2023-2 sets out what it must contain: accessible without registration, covering all activities in the designation scope, stating whether each fee is flat or time-based, naming the factors affecting the calculation, giving ranges, and stating how smaller enterprises are treated. Compare the published lists before the quotations — a low audit day rate with time-based documentation review can finish above a higher flat fee.
5. Separate the written agreement from the certificate
Annex VII Section 4.3 requires the contract between body and manufacturer to be a written agreement signed by both parties. That is a milestone, not the finish line, and the two are routinely confused.
The Commission’s 20th notified bodies survey, with data to 28 February 2026 and a 100% response rate, reports 65% of MDR applications reaching a signed written agreement within two months. The certificate is another matter: 62% of bodies report 13 to 18 months for a quality management system certificate, and for a combined QMS and product certificate 51% report 13 to 18 months with a further 31% at 19 to 24 months. No official source publishes an average, so plan against 13 to 24 months.
Where this goes wrong
Applying to a body that holds your vertical code but not your horizontal one. MDA and MDN get checked; MDS and MDT do not. The application is accepted at reception and refused at review, weeks later.
Assuming an MDD-era relationship carries over. A body that certified your device under Directive 93/42/EEC is not necessarily designated under Regulation (EU) 2017/745 for your codes. Check NANDO code by code.
Lodging applications with two bodies to see which is quicker. Article 53(1) prohibits applying in parallel to another notified body for the same conformity assessment procedure, and Article 53(3) requires you to declare any application withdrawn before that body’s decision and any previously refused one. Under Article 53(2) the body must inform the others through the Article 57 electronic system when a manufacturer withdraws before a decision. Shopping around is visible, and it follows you.
Treating the body’s timeline as the whole timeline. The same survey records only 14 of the 52 MDR-designated bodies saying more than half the submissions they receive are complete. When a project overruns, the cause is usually the file, not the queue.
Expecting the notified body to tell you how to close a gap. MDCG 2019-6 Rev.5 bounds structured dialogue to what has to be met, not how to meet it; a pre-application gap analysis or quality management system pre-review is consultancy and is not permitted. The body will tell you your clinical evidence is insufficient. It will not tell you what would be sufficient.
Assuming the Article 120 extension still applies. As amended by Regulation (EU) 2023/607, the transitional deadlines run to 31 December 2027 for Class III and Class IIb implantable devices, and to 31 December 2028 for other Class IIb, Class IIa and those Class I devices that need a notified body, under Article 120(3a)(b) and 120(3b). Both dates depend on the Article 120(3c) conditions, among them a formal application lodged by 26 May 2024 and a written agreement signed by 26 September 2024. If that agreement was not signed, changing notified body now does not recover the extension.
Frequently asked questions
Can we apply to more than one notified body at once?
No. Article 53(1) prohibits lodging an application in parallel with another body for the same conformity assessment procedure, and Article 53(3) requires you to declare any application withdrawn before that body’s decision, and any previously refused one.
As an Indian manufacturer, can we use any notified body in the EU?
Yes. Article 53(1) gives a free choice among bodies designated for the activities, procedures and devices concerned, with no requirement to use one in any particular Member State. Separately, a manufacturer outside the EU must appoint an EU authorised representative under Article 11 before placing a device on the Union market — a different appointment with different duties.
What happens if our notified body’s designation is suspended or withdrawn?
Under Article 46 the body must notify affected manufacturers within ten days, and a suspension may not exceed one year, renewable once. On withdrawal, certificates may remain valid for nine months if the competent authorities confirm there is no safety issue and another body takes over, extendable in three-month increments to twelve months.
Can a notified body review our technical file before we apply?
It can hold a structured dialogue under MDCG 2019-6 Rev.5 and confirm your classification, codes and designation coverage. It cannot carry out a pre-application gap analysis or a quality management system pre-review.
Getting the selection right first time
Notified body selection is a documentation exercise before it is a commercial one. Confirm your classification, establish your codes, work out which Article 52 route applies, then approach only the bodies whose NANDO entry covers all of it. Medfins runs this check as part of our CE marking and EU MDR work — send us your device description and intended purpose and we will tell you which codes you need.
