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NB Requirement Tool

Do I Need a Notified Body?

Answer 4 questions to find out whether your medical device or IVD requires a Notified Body under MDR 2017/745 or IVDR 2017/746. Every answer includes the regulatory article it is based on.

Find a Notified Body
What type of product are you classifying?
MDR 2017/745 applies to medical devices. IVDR 2017/746 applies to in-vitro diagnostic devices.
What is the MDR classification of your device?
MDR Annex VIII classification rules apply.
Does your Class I device have any of the following?
MDR Article 52(7) triggers partial NB involvement for these.
What is the IVDR classification of your IVD?
IVDR Annex VIII: Class A (lowest) to Class D (highest risk).

No Notified Body required

A standard Class I non-sterile, non-measuring device does not require an NB. Self-declare conformity and apply the CE mark. You still need an EU Authorized Representative if outside the EU, EUDAMED registration, and a technical file.

Regulatory basisMDR 2017/745, Article 52(7)

Partial Notified Body involvement required

Your Class I device requires NB involvement only for the specific aspect: sterile state, measuring function, or reusable surgical instrument. The NB assesses only those aspects under Annex IX (Chapter I) or Annex XI (Part A).

Regulatory basisMDR 2017/745, Article 52(7)

Notified Body required

All Class IIa devices require an NB. Assessment: technical documentation or type examination + QMS audit. Capacity more available than IIb/III but still constrained in 2026.

Regulatory basisMDR 2017/745, Article 52(4) - Annex IX (Ch. I-II) or Annex X + Annex XI (Part A).

Notified Body required

All Class IIb devices require an NB. Typical queue 10-16 months in 2026. Implantable Class IIb has additional scrutiny under Article 54.

Regulatory basisMDR 2017/745, Article 52(3) - Annex IX (Ch. I-II) or Annex X + Annex XI. Article 54 for implantables.

Notified Body required

Class III requires full quality assurance + design dossier examination. Most major NBs have 18-24 month waitlists. Start your NB search immediately.

Regulatory basisMDR 2017/745, Article 52(1)(2) - Annex IX (all chapters) or Annex X + Annex XI (Part A). Article 54 scrutiny.

Notified Body required

Annex XVI products (aesthetic, no medical purpose) require NB involvement equivalent to Class III regardless of risk.

Regulatory basisMDR 2017/745, Article 1(2) and Annex XVI - Article 52(1). Commission Regulation (EU) 2021/2078.

No Notified Body required

Class A laboratory IVDs (not self-test, not sterile) do not require an NB. Self-declare conformity. Note: sterile Class A IVDs need NB for sterility aspects.

Regulatory basisIVDR 2017/746, Article 48(3)

Notified Body required

Class A self-test IVDs require NB involvement. The NB assesses aspects related to the intended lay user population.

Regulatory basisIVDR 2017/746, Article 48(3) second subparagraph

Notified Body required

All Class B IVDs require an NB. Assessment: QMS + technical documentation for at least one representative device per generic device group.

Regulatory basisIVDR 2017/746, Article 48(2) - Annex IX (Ch. I + tech doc) or Annex X + Annex XI (Part A).

Notified Body required

All Class C IVDs require full NB quality assurance and tech doc review for each device. Includes blood grouping, HLA typing, tumour markers, STI diagnostics.

Regulatory basisIVDR 2017/746, Article 48(1)(b) - Annex IX (all chapters) or Annex X + Annex XI (Part A).

Notified Body required - highest scrutiny

Class D requires batch verification and EMA consultation for companion diagnostics. Very few NBs designated for Class D. Timelines 24+ months.

Regulatory basisIVDR 2017/746, Article 48(1)(a) - Annex IX (all chapters) + Annex XI (Part B). Companion dx: Article 48(6).

About this tool

Based on MDR 2017/745 (Articles 52-58, Annexes IX-XI) and IVDR 2017/746 (Articles 48-54, Annexes IX-XI). Every result includes the regulatory article. Does not replace regulatory affairs advice for borderline products.

Does a Class I medical device need a Notified Body?

Standard Class I (non-sterile, non-measuring) does not require an NB - self-declaration under MDR Article 52(7). Three subtypes do: sterile state, measuring function, reusable surgical instruments.

Which IVDR classes need a Notified Body?

Class A laboratory IVDs (not self-test, not sterile) are exempt. All others - A self-test, B, C, D - require NB. Class D also requires batch verification and EMA consultation for companion diagnostics.

How long does NB conformity assessment take in 2026?

Typical 2026 timelines: Class IIa 6-10 months, Class IIb 10-16 months, Class III 18-24 months. IVDR Class D comparable to MDR Class III. Start NB selection as early as possible.

Find a Notified Body for your device

Submit one structured request - ECP matches your device class and scope to NBs with current availability.