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How to choose a notified body

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice.

The choice matters​

Not all notified bodies have the same scope, capacity, or expertise. Choosing the right NB for your device is one of the most consequential regulatory decisions a manufacturer makes. The wrong choice can result in assessment delays, requirements to change NBs mid-process, or inadequate scrutiny that creates problems at surveillance.

Step 1 — Check NANDO for designation scope​

Start with the NANDO database (ec.europa.eu/growth/tools-databases/nando). Filter by:

  • Regulation: MDR 2017/745 or IVDR 2017/746
  • Annex: which conformity assessment annex you need (IX, X, XI)
  • Device type: NANDO allows filtering by device category or product code

Only NBs designated for your specific device type and conformity assessment route can assess your device. An NB designated for general surgical instruments may not be designated for active implantable devices.

Step 2 — Assess capacity and waitlists​

With fewer designated NBs than under MDD/AIMDD/IVDD, NB capacity is constrained. Before applying, ask prospective NBs:

  • What is the current waiting time for a new application in your device category?
  • What is the timeline from application submission to certificate issue for Class IIa / IIb / III?
  • Do you have capacity for unannounced audits within the required frequency?

For Class III devices, realistic timelines from application to certificate are 18–36 months. Contact NBs at least 12–24 months before you need the certificate.

Step 3 — Assess technical expertise​

Request information on the NB's:

  • Clinical evaluators and technical experts in your device category
  • Experience with your device type or clinical area (ask for references or examples)
  • Expert panel connections for Art. 54 consultations (Class III)
  • EMA/NCA relationships for drug-device combination or companion diagnostic assessments

Step 4 — Understand fees and commercial terms​

NB fees vary significantly. Factors include:

  • Device class and complexity
  • Number of product variants in scope
  • Number of manufacturing sites
  • Audit frequency and travel requirements
  • Annual surveillance fee structure

Obtain a detailed fee estimate before committing. Fees are not regulated — they are commercial contracts between manufacturer and NB.

Step 5 — Due diligence on the NB itself​

  • Verify the NB's NANDO listing is current and covers your scope
  • Review any publicly available MDCG assessments or peer reviews of the NB
  • Consider the NB's financial stability — changing NBs mid-certification is disruptive and costly
  • Review the NB's certificate suspension/withdrawal history in NANDO — a history of suspended certificates may indicate quality issues

Audit process & timelines​

A typical Annex IX assessment for a Class IIb device proceeds:

StageTypical duration
Pre-application discussion1–3 months
Application review and acceptance2–4 months
Documentary review (QMS and Tech Doc)3–6 months
On-site initial audit1–3 days (plus preparation)
Non-conformity resolution1–6 months (varies)
Certificate decision1–2 months after all NCRs closed
Total: Class IIb device12–24 months

For Class III devices, add the expert panel consultation (up to 60 days plus NB decision time), and more extensive technical documentation review. Total: 18–36+ months.

Unannounced audits — MDR Art. 93​

For Class III devices, the notified body must conduct at least one unannounced audit of the manufacturing site within the certification period. Additional unannounced audits may be conducted at any time.

Key features:

  • No prior notice — the NB arrives without announcement
  • Short-notice inspection — manufacturer must be able to receive the audit team within 24 hours' notice
  • Covers manufacturing processes, QMS implementation, and records
  • NCAs may also conduct their own unannounced inspections independently of the NB

Manufacturers should maintain continuous audit readiness — QMS records, production processes, and staff awareness must be current at all times.

Scrutiny procedure — MDR Art. 54​

For certain Class III devices and Class IIb devices (those in contact with the heart, CNS, or central circulatory system), before issuing or renewing a certificate the NB must:

  1. Notify the MDCG of the application (via EUDAMED)
  2. Submit the clinical evaluation assessment report to an expert panel for scientific opinion
  3. Wait up to 60 days for the opinion
  4. Take the opinion into account in its certification decision
  5. Document any departure from the expert panel's opinion with justification

The expert panels are designated by the Commission and consist of independent clinical and technical experts. Their opinions are published on EUDAMED.

This process can add 3–6 months to Class III certification timelines. Factor it into planning.

NANDO database — quick guide​

The NANDO database allows users to:

  • Search NBs by regulation, country, and device category
  • View each NB's designation scope in detail
  • Access contact information for NB applications
  • View certificate issuance history (in EUDAMED, linked from NANDO)

Practical tip: use NANDO's advanced search to filter by "MDR 2017/745" AND the specific Annex (IX, X, XI) AND product code to find NBs qualified for your exact device type.

Official references​

ReferenceDescription
MDR Art. 36–50NB designation and obligations
MDR Art. 93Unannounced audits
MDR Art. 54Scrutiny procedure (expert panel consultation)
NANDO databaseec.europa.eu/growth/tools-databases/nando
MDCG 2020-11Conformity assessment procedure selection