EU MDR Notified Body Selection: Designation Scope, Codes and NANDO Checks

1. Key takeaways

The European Commission states in COM(2025) 1023 final, dated 2025-12-16, that 51 notified bodies have been designated under the MDR and 19 under the IVDR. The core action in selecting a notified body is verifying whether the designation scope covers the classification and the codes of the product concerned. Designations are made under Article 42, the code system follows Implementing Regulation (EU) 2017/2185, and the real-time status must be taken from the NANDO database.

Three checks are distinct and none of them can substitute for the others. First, the legal capacity check: whether the designation scope of a given body covers your product class and code at all. Second, the factual status check: whether the designation is currently valid, restricted or withdrawn, which only NANDO confirms authoritatively. Third, the capacity check: whether the body can schedule your project within a commercially acceptable window. Confusing the first with the third is the most common selection error, because a body may be legally able to assess your device type yet unable to start the project for many months, and the reverse may also be true during quiet periods.

2. Legal basis

The designation framework rests on Article 42 and Annex VII of Regulation (EU) 2017/745, with the codes that define designation scopes established by Implementing Regulation (EU) 2017/2185 in 2017. The 2026 harmonised requirements under Implementing Regulation (EU) 2026/977 add an operational layer. The figures cited in the Commission proposal COM(2025) 1023 final of 2025-12-16, procedure number 2025/0404 (COD), come from the official proposal text and can be quoted as such, subject to the NANDO caveat explained below.

3. Expert insights

Insight one: designation scope is whether the body can take the project, and capacity is how long until it can.

Two questions must be kept apart: whether the designation scope of a body covers the product, which is a question of legal qualification, and what the current case load of that body is, which is a scheduling question. The first cannot be negotiated; the second can be discussed but is constrained by the capacity of the entire sector. The European Commission notes in the same proposal that the lack of predictable deadlines for conformity assessment is one of the problems the legislative revision is intended to solve, which confirms that scheduling pressure is structural rather than an artefact of any single body. Selection processes that do not model the scheduling dimension produce project plans that fail at their first milestone.

Insight two: the figure of 51 is an official number from the proposal text, not an industry estimate.

This figure comes from the explanatory part of the legislative proposal COM(2025) 1023 final and can be cited on that basis. However, whether any specific body is currently valid, and whether its designation scope has been changed or restricted, must be verified against the real-time status of the NANDO database; older screenshots and third-party summaries are not acceptable substitutes. Designations evolve continuously: scopes are extended after new audits, restricted after surveillance findings, and withdrawn in enforcement cases. A selection shortlist built from a static list quickly diverges from reality, so the verification step belongs at the moment of application, not merely at the moment of first research.

Insight three: the code system is the language in which scope is determined.

Under Implementing Regulation (EU) 2017/2185, the designation scope of a notified body is expressed as codes corresponding to device types. The manufacturer must map its product to the relevant codes and compare them with the scope of the body under consideration. Errors in this mapping lead to rejected applications or to a mid-project transfer to another body, both of which cost time and negotiating leverage. Because the code definitions are drafted in regulatory language, the mapping exercise is not purely clerical; borderline devices may plausibly sit under more than one code, and the safest practice is to confirm the mapping with the body itself before issuing a formal application.

Insight four: the 2026 instrument (EU) 2026/977 has changed the harmonised requirements for notified bodies.

Implementing Regulation (EU) 2026/977, dated 2026, establishes harmonised requirements for conformity assessment and notified bodies under Annex VII. This layer of detail influences the internal processes and assessment depth of each body, which in turn affects project scheduling and the extent of documentation preparation. Manufacturers should treat this instrument as part of the selection due diligence: a body operating under harmonised requirements may request evidence in a different structure than bodies reviewed under older practice, and contracts signed before the operational changes took effect should be revisited for alignment.

4. Practical recommendations

1. Build a candidate list and record for each body its identification number, designation scope codes, covered classes, current status and language capabilities, so that comparisons rest on structured data rather than impressions.
2. Use the real-time NANDO status as the authority, and do not rely solely on self-descriptions from the bodies or third-party summary tables when making shortlist decisions.
3. Map the product to the codes of (EU) 2017/2185 before sending requests for quotation, so that a scope mismatch does not waste a full round of communication.
4. State in the quotation request the device classification, the maturity of the technical documentation, whether software is included and whether an expert panel procedure is needed, reducing misjudgements by the body.
5. Maintain a second candidate body with the same designation scope as a backup, against the risks of scheduling overruns or scope changes at the primary candidate.

5. Verification checklist

• □ The identification numbers and designation scope codes of candidate bodies have been obtained
• □ The current valid status of each body has been checked in NANDO
• □ The product has been mapped to the codes of (EU) 2017/2185
• □ The scope of the selected body has been confirmed to cover the device class of the project
• □ Whether the Article 54 expert panel procedure applies has been confirmed
• □ The impact of (EU) 2026/977 on body procedures has been checked

GRZAN supports manufacturers, authorised representatives and importers across the EU MDR market with CE marking pathway selection and classification strategy, including notified body selection: code mapping under (EU) 2017/2185, NANDO verification, quotation documentation and backup-body planning. For a practical estimate of assessment timelines and notified body scoping for your portfolio, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 2026-10-29.