EU IVDR Notified Body Selection: NANDO Screening, Scope Codes and Fees

1. Key takeaways

Notified bodies in the EU are designated by the competent authorities of the Member States, on the legal framework of Articles 31 to 46 of the IVDR and Annex VII. On the numbers: the twentieth Commission survey of notified bodies (data as of 2026-02-28, published 2026-07-02) reports 52 designated under the MDR and 19 under the IVDR; a public NANDO search shows a differing count (17 in a third-party retrieval on 2026-10-07). The correct way to select a body is not to compare reputations but to verify designation status and scope codes one by one in NANDO, and to confirm in writing whether the body accepts applications of the relevant type.

Capacity remains the structural constraint of the IVDR transition: nineteen designated bodies carry the certification demand of an entire market of legacy and new devices. Selection therefore has a scheduling dimension as much as a quality dimension. The upcoming Implementing Regulation (EU) 2026/977 will standardise quotations, timelines and reporting, which will make body performance comparable on data rather than anecdote, and Article 46 on standard fees strengthens the negotiating position of manufacturers at the quotation stage.

2. Legal basis

The table below lists the primary legal sources on notified body designation and selection.

3. Expert insights

Insight 1: designated does not mean able to assess your product, and certainly not accepting new applications.

The scope in a designation record is expressed through codes under the coding system of (EU) 2017/2185. A designation under the MDR does not automatically extend to the IVDR, and a designation covering Class B does not automatically cover Class D. Furthermore, NANDO does not reflect whether a body is still receiving new applications or what its real capacity is; both questions must be asked in writing. A selection process that stops at the NANDO entry therefore systematically overlooks the two facts that most often derail projects, missing scope coverage and an assessment calendar that is already full.

Insight 2: capacity is the structural constraint of the IVDR transition.

The Commission recorded in the explanatory material of proposal COM(2025) 1023 that, to date, 51 bodies under the MDR and 19 under the IVDR have been designated (proposal text count). The Commission survey and the proposal text differ slightly (52 and 19), and third-party NANDO retrievals differ again. When citing numbers, state the source and the cut-off date, and treat NANDO as the only live reference. For manufacturers, the actionable conclusion is that queue positions are a scarce resource: early filing with a pre-organised documentation package is worth more than late perfection.

Insight 3: (EU) 2026/977 will change the dimensions of body selection.

Applicable from 2027-02-25, this implementing act harmonises the quotation content, maximum time limits, interruption rules and annual reporting of notified bodies: review of the application and contract conclusion within 30 days, QMS audit within 120 days, technical documentation assessment of the products within 90 days, and decision, certificate issuance and entry into EUDAMED within 20 days; a fee increase of more than 10% over the quotation requires prior written justification; and from 2028, each body publishes an annual report with the median fees and completion rates of the previous year by April 30. From then on, body efficiency becomes comparable data rather than hearsay, and selection can be benchmarked against published completion rates.

Insight 4: Article 46 provides the legal basis for fee transparency.

Article 46 requires the Commission to publish a list of standard fees for notified bodies. Combined with the quotation breakdown obligations of (EU) 2026/977 (separate items for QMS audit and technical documentation assessment, routine surveillance and unannounced audit fees, an estimate of potential additional costs and an estimated timetable), manufacturers are in a materially stronger position at the request-for-quotation stage. Asking every candidate body for the same breakdown makes bids comparable line by line and exposes hidden cost drivers early.

4. Practical recommendations

The following actions structure a defensible notified body selection process.

1. Start from NANDO filtered for Regulation (EU) 2017/746 and check body by body whether the scope codes cover the device category and technology of your product.
2. Confirm in writing with each candidate body four points: whether it accepts the product type, the required materials, the current contracting and assessment schedule, and whether it can support the EURL process (Class D).
3. Request quotations broken down in line with (EU) 2026/977 (QMS, technical documentation, surveillance, unannounced audits, potential additional costs, timetable).
4. Agree contract clauses on time limits, interruption rules and prior notification of fee increases above 10%.
5. Maintain a list of alternative bodies to avoid project interruption if a single body’s designation scope changes (Article 42).

5. Verification checklist

Confirm the following points before signing with a notified body.

• □ The designation status and scope codes of candidate bodies under Regulation (EU) 2017/746 have been verified in NANDO
• □ Written confirmation has been obtained that the body accepts the product type and of the current schedule
• □ For Class D projects, the body’s ability to support the EURL process has been confirmed
• □ Quotations have been broken down in line with (EU) 2026/977 (mandatory after 2027-02-25)
• □ The contract contains clauses on time limits, interruption and fee increase notification
• □ A list of alternative bodies is maintained (risk of designation changes under Article 42)

Regulatory information verified as of October 29, 2026.

GRZAN supports IVD manufacturers in the EU market with CE certification pathway and classification strategy under Regulation (EU) 2017/746. For notified body selection we help you screen NANDO scope codes, structure written capability inquiries, benchmark quotations against the (EU) 2026/977 framework and manage backup body strategies. Contact us at info@grzanglobal.com to discuss your EU IVDR programme.