IVDR Notified Body: The 4 Essential Routes and When You Need One

An IVDR notified body is the organisation designated by a Member State under Regulation (EU) 2017/746 to assess whether an in vitro diagnostic device conforms before it is CE marked, and under the IVDR almost every manufacturer needs one. Article 48 involves a notified body for every class B, C and D device and for the sterility of class A sterile devices; only class A non-sterile devices are self-declared.

That is the reverse of the Directive it replaced, under which most IVDs never met a notified body at all, and it collides with a supply problem: the IVDR list on NANDO is far shorter than the MDR list, and Article 110’s transitional route for legacy devices depends on a signed written agreement with one of those bodies by a fixed date. This guide sets out the four conformity assessment routes and what the notified body does in each, the extra steps for class D, self-testing and companion diagnostics, what the engagement looks like from application to surveillance, what Article 46 requires bodies to publish about fees, and how to choose and secure one while capacity is the constraint.

When you need an IVDR notified body

Because class B is the residual class under Annex VIII rule 6, a manufacturer who cannot place a device in class A by rule 5 needs a notified body. Our guide to IVDR classification works through the rules; the class you land in decides the route, the sampling basis and the price.

The four routes and what the body assesses

Under Article 51(2) every IVDR notified body certificate is valid for the period it states, not exceeding five years, and is renewed on re-assessment for further periods of up to five years. The written agreement under Annex VII Section 4.3 obliges the manufacturer to inform the body of vigilance reports and gives the body the right to suspend, restrict or withdraw certificates.

Extra steps for class D, self-testing and companion diagnostics

• Class D: the IVDR notified body has the most to do here — where an EU reference laboratory has been designated under Article 100, the notified body must have it verify by laboratory testing the performance claimed and compliance with the common specifications (Article 48(5)); for a first certification of a type with no common specifications, the body consults the expert panel on the performance evaluation report (Article 48(6)); and batch verification applies under Annex IX Section 4.12 or Annex XI.
• Self-testing and near-patient testing (class B, C or D): technical documentation assessment under Annex IX Section 5.1 for the device, including studies carried out with intended users.
• Companion diagnostics (class C): Annex IX Section 5.2 for every device, with consultation of a medicines competent authority or the EMA — not on a representative basis.

What Article 46 makes the IVDR notified body publish

Article 46 is one sentence: notified bodies “shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available”. MDCG 2023-2, published January 2023 with an IVDR form, adds that the list must be reachable on the body’s NANDO-registered website without registration, should say whether each item is flat or time-based, and that duly justified external costs — the EU reference laboratory testing for class D is the IVDR-specific one — may be charged on top.

The Commission links each body’s list from its notified bodies page. The price list gives the rate; the number of assessment days is set by the quality of the file, which is why IVDR technical documentation is the largest controllable cost. Our guide to notified body fees reads three published MDR price lists line by line; the IVDR lists use the same MDCG 2023-2 headings.

The engagement, step by step

1. Classify and choose the route before approaching anyone; the body will verify both under Annex VII Section 4.3(b) and (c).
2. Check designation scope. Bodies are designated by code under Implementing Regulation (EU) 2017/2185; a body designated for immunoassays may not be designated for molecular or for class D. NANDO shows each body’s scope.
3. Lodge the formal application — signed, containing the information and declarations the chosen annex requires. For legacy devices under Article 110, this is a dated condition: 26 May 2026 for class C, 26 May 2027 for class B and class A sterile.
4. Sign the written agreement. Annex VII Section 4.3 requires a contract signed by both parties; Article 110 makes it a second dated condition — 26 September 2026 for class C, 26 September 2027 for class B and class A sterile. Our guide to IVDR transition deadlines covers the consequences of missing either.
5. QMS audit, then technical documentation assessment, with question rounds; the number of rounds is where the calendar and the fee both stretch.
6. Certificate, then surveillance: annual audits, a PSUR reviewed each year for class C and D, unannounced audits within five years, renewal by re-assessment before the certificate’s stated expiry.

Choosing an IVDR notified body while capacity is short

• Scope first, price second. A body without the designation code for your device type cannot take the file at any price.
• Ask for the current lead time to written agreement and to first audit, in writing; Article 110’s dates make the first number the one that matters.
• Read the published fee list and ask which items are time-based and what the body’s assumed days are for your class.
• Language. Article 48(12) lets the body’s Member State require documents in its official language; confirm what the body will accept.
• Portfolio grouping. For class B and C, how the body defines categories and generic device groups decides how many files are sampled.

Frequently asked questions

Which IVDs need an IVDR notified body?
Every class B, C and D device, and class A sterile devices for their sterility aspects, under Article 48. Only class A non-sterile devices are self-declared, and in-house devices meeting all Article 5(5) conditions are exempt from conformity assessment.

How long is an IVDR certificate valid?
Up to five years under Article 51(2), renewable for further periods of up to five years on re-assessment. Surveillance audits run at least every 12 months and unannounced audits at least once every five years.

Do notified bodies have to publish their fees?
Yes. Article 46 requires each body to publish a list of its standard fees, and MDCG 2023-2 provides the IVDR form and requires the list to be freely accessible on the body’s website.

What is different for class D?
Every technical file is assessed, an EU reference laboratory verifies claimed performance and CS compliance where one is designated, the expert panel is consulted for a first-of-type without CS, and batches are verified before release.

What are the Article 110 notified body deadlines?
For legacy devices: a formal application by 26 May 2026 and a signed written agreement by 26 September 2026 for class C; 26 May 2027 and 26 September 2027 for class B and class A sterile. Class D’s dates — 26 May and 26 September 2025 — have passed.

Where this leaves you

Treat the IVDR notified body as a supply-constrained input: classify, pick the route, check the designation codes on NANDO, lodge the application and sign the written agreement before the Article 110 dates if the device is legacy, read the Article 46 fee list for the time-based items, and submit a file that keeps the question rounds short. The certificate is the output; the engagement is the programme.

References

• Regulation (EU) 2017/746, consolidated text of 10 January 2025 — Articles 46, 48, 51, 100 and 110; Annex VII Section 4.3; Annex IX Sections 3.3, 3.4, 4, 5.1 and 5.2.
• European Commission: notified bodies for medical devices — Links to the NANDO lists for the MDR and the IVDR, the designation-code coverage summary and the published fee lists.

More on the EU IVDR

• IVDR notified body — you are here
• EU IVDR: Regulation (EU) 2017/746 explained
• IVDR classification
• IVDR transition deadlines
• IVDR technical documentation
• IVDR vs IVDD

The Notified Body Application and Interaction Procedure, the Notified Body and Certificate Log, the Device Classification Procedure and the Transition Deadline and Condition Tracker are in the EU IVDR Toolkit, or start with the free templates.