NB Requirement Tool
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.
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.
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).
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.
All Class IIb devices require an NB. Typical queue 10-16 months in 2026. Implantable Class IIb has additional scrutiny under Article 54.
Class III requires full quality assurance + design dossier examination. Most major NBs have 18-24 month waitlists. Start your NB search immediately.
Annex XVI products (aesthetic, no medical purpose) require NB involvement equivalent to Class III regardless of risk.
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.
Class A self-test IVDs require NB involvement. The NB assesses aspects related to the intended lay user population.
All Class B IVDs require an NB. Assessment: QMS + technical documentation for at least one representative device per generic device group.
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.
Class D requires batch verification and EMA consultation for companion diagnostics. Very few NBs designated for Class D. Timelines 24+ months.
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.
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.
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.
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.
Submit one structured request - AFINA matches your device class and scope to NBs with current availability.
Send the product details and we will suggest the next practical compliance step.