Choosing a Notified Body for Medical Devices

The way to choose a notified body is to start with your device's MDR (or IVDR) codes and class, list only the bodies designated in NANDO for those codes, then compare those bodies on published fees, process and capacity during a pre-application "structured dialogue". The MDCG guidance treats this pre-application stage as the formal place to settle classification, codes, timelines and fees before you apply.

Approach: The MDR/IVDR text, NANDO and MDCG datasets did not respond this session, and EUR-Lex would not open. So this answer rests on official Commission and MDCG pages and the MHRA GOV.UK page. I could not quote the MDR articles themselves, and I give article numbers only as MDCG cites them.

1. Narrow the field to bodies designated for your scope (EU)

• Use NANDO as the official register. The Commission's notified bodies page points to NANDO, with filtered lists for MDR (2017/745) and IVDR (2017/746) bodies (Commission page).

• Match on your codes, not just the body's name. MDCG 2019-6 rev.5 says that before issuing a quotation, a notified body is legally required (Annex VII 4.2(d)) to check three things:

  • whether the product falls under the Regulations;
  • whether its classification is correct and whether it could be an orphan device;
  • which MD/IVD codes apply, under Implementing Regulation (EU) 2017/2185.

  Work out your codes first and make sure every one of them is in the body's designated scope.

• Check the designation is live. A body cannot accept MDR/IVDR applications until "the day after the notification is published in NANDO" (MDCG 2019-6, Q&A I.7) (MDCG 2019-6 rev.5).

2. Compare costs using their published fee lists

• MDR Article 50 and IVDR Article 46 say notified bodies "shall establish lists of their standard fees … and shall make those lists publicly available" (MDCG 2023-2).
• Where to find the list: it should be on the website registered in NANDO, with no log-in needed, in local currency, and showing any regional price differences (MDCG 2023-2).
• What it should show:
  • whether each item is a flat or time-based fee;
  • fee ranges and the factors that drive them;
  • how SME interests are taken into account (Annex VII 1.2.8 requires terms that are "fair and reasonable").
• What to compare: the main items are the application fee, annual maintenance fee, audits (including unannounced audits), technical documentation assessment, clinical evaluation assessment report (CEAR) review, SSCP validation, PSUR review, change assessments and consultation fees.
• Quotes can move. The final fee can differ from the quote. If the difference is substantial, the body should tell you and justify it (MDCG 2023-2).

3. Test process and fit in a structured dialogue

MDCG 2019-6 (Q&A I.6.3) says the notified body should give you a full overview of its certification process. This includes contract terms, forms, what documents are needed and when, languages accepted, timelines, and fees. Structured dialogue should not carry extra fees. Useful pre-application topics it lists:

• timelines, including special procedures (drug-device combinations, companion diagnostics, orphan devices);
• options for the conformity assessment route, and submission timing for legacy devices;
• whether a "modular approach" is possible (parts of the technical documentation reviewed at different times);
• acceptance of third-party test reports, and reuse of evidence from earlier assessments (Q&A IV.13);
• the preferred structure for technical documentation, and sampling requirements.

Limits:

• Before you apply, the body must not review clinical data, assess your quality system, or do gap analyses or MDR-readiness checks. These count as consultancy (Q&A I.6.2).
• Once you apply, everything counts as conformity assessment. If you withdraw, the body has to inform other notified bodies through EUDAMED under MDR Article 53(2) / IVDR Article 49(2). So choose before you apply, not by applying to several bodies.

4. Changing body later

• Transfers are possible. MDR Article 58 / IVDR Article 53 allow a voluntary transfer under a transfer agreement.
• What the new body must do:
  • For quality system certificates, it needs on-site audits before it issues anything.
  • For technical documentation sampled across a device range, it shall review the previous results and a sample.
  • Product certificates may be reissued without a full review if no concerns come up.
  • The incoming body takes full responsibility (Q&A IV.4).
• What stays the same: surveillance audits are at least every 12 months, with a ±3-month window (Q&A IV.10). Recertification runs for up to five years at a time (Q&A IV.12).

5. Great Britain (UKCA)

For GB you need a UK approved body under the Medical Devices Regulations 2002. MHRA's list (updated 17 July 2026) names:

• BSI Assurance UK Ltd
• DEKRA Certification UK Ltd
• Eurofins E&E CML Limited
• Intertek Medical Notified Body UK Ltd
• Scarlet NB UK Ltd
• SGS United Kingdom Limited
• TUV Rheinland UK Limited
• TUV SUD BABT Unlimited
• UL International (UK) Ltd
• Therapeutic Goods Administration (TGA)

Each has a downloadable scope document, and you should check it against your device type in the same way as step 1 (MHRA: UK approved bodies).

If you share your device description, class and intended markets, I can match it to MDR codes and list the NANDO-designated bodies that cover them.