Notified Body

What it is

Notified Body (NB) is a conformity assessment organization designated and monitored by an EU/EEA Member State to assess medical devices and IVDs against EU law. NBs review technical documentation, audit QMS, and issue CE certificates when requirements are met (MDR 2017/745 Chapter IV Arts. 35–50; IVDR 2017/746 Chapter IV; Annex VII competence/independence criteria).

Regulatory framework

• Designation & scope: Member States designate NBs and define their scope; Commission lists them publicly; ongoing surveillance applies (MDR Arts. 35–44; IVDR Arts. 30–37; Annex VII).
• Duties: Perform conformity assessment per Annex IX–XI (MDR/IVDR), including QMS audits, technical file reviews, sampling, and certificate issuance/maintenance (MDR Arts. 52–58; IVDR Arts. 48–51).
• Certificates: Types and content governed by MDR/IVDR (e.g., MDR Art. 56; Annex XII) with defined validity and conditions for suspension/withdrawal (MDR Arts. 54, 57–58; IVDR Arts. 50–51).
• Unannounced audits: NBs may conduct unannounced on-site audits and product testing during surveillance (MDR Annex IX §3.4; IVDR Annex IX §3.4).

Key elements

• Impartiality & competence: Organizational independence, qualified reviewers/auditors, and decision makers separate from commercial pressure (Annex VII).
• Defined scope: Designation covers specific device codes/technologies and sterilization; manufacturers must match their portfolio to NB scope.
• Lifecycle oversight: Initial assessment, certificate issue, surveillance audits, change reviews, and recertification.
• Enforcement levers: Conditions, restrictions, suspension, or withdrawal of certificates when nonconformities persist (MDR Art. 58; IVDR Art. 51).

Process — how it works

• Select & apply: Choose an NB with the right designation codes; submit an application with product scope and QMS details.
• Plan & review: Agree the assessment route (e.g., Annex IX QMS + design, Annex X type-exam, Annex XI production); NB plans audits and file reviews.
• Assess: Undergo QMS audits and technical documentation evaluations; address questions and nonconformities within timelines.
• Decide & certify: NB issues CE certificates when conformity is demonstrated; devices then proceed to CE marking and registration.
• Surveil & change control: NB performs surveillance (including unannounced audits), reviews significant changes, and maintains certificate status.

Common pitfalls

• Choosing an NB without the necessary designation codes for your technologies or sterilization methods.
• Underestimating evidence depth for clinical evaluation/performance evaluation tied to claims (MDR Art. 61; IVDR Annex XIII).
• Submitting incomplete technical documentation (gaps to Annex II–III) or weak GSPR mapping (Annex I).
• Managing changes informally; significant changes require NB assessment before implementation.
• Neglecting surveillance readiness, including post-market data quality and CAPA effectiveness.

Quick checks / Tips

• Match device codes and scope to the NB’s designation; confirm capacity and lead times early.
• Align intended purpose and claims with clinical/performance evidence; close gaps before submission.
• Use clear traceability: GSPRs → evidence → test reports → risk controls → labeling.
• Pre-stage significant change criteria and notify the NB before executing changes.
• Stay audit-ready: PMS/PSUR, vigilance files, UDI/EUDAMED entries, and CAPA must be current.