Notified Bodies
A Notified Body is a conformity assessment organisation designated by an EU Member State authority to carry out third-party conformity assessment tasks specified in EU harmonisation legislation. Notified Bodies are not EU institutions, not Commission agencies, and not arms of national administrations. They are independent organisations — typically private companies — formally designated for specific tasks under specific acts. They are listed in the Commission's NANDO database under a four-digit identification number that becomes part of the CE marking on products they have certified.
A Notified Body is required only where the applicable harmonisation act mandates third-party involvement in the conformity assessment for a given product category. For the lowest-risk product categories (most LVD and EMC products, machinery outside Annex I of Regulation 2023/1230, Category I PPE, most toys complying with harmonised standards), no Notified Body is involved and the manufacturer self-declares conformity under Module A.
Legal basis
- Decision No 768/2008/EC, Articles R17–R34 (designation, monitoring, operational obligations of Notified Bodies). These reference provisions are incorporated by every sectoral act.
- Sectoral acts add specific requirements — e.g., Articles 26–46 and Annex VII of Regulation (EU) 2017/745 (MDR) set out the most detailed Notified Body framework in EU law, including the "joint assessment" procedure for designations.
- Regulation (EU) No 765/2008, Article 30(4) — the Notified Body identification number is affixed next to the CE mark when the body has been involved in the production-control phase.
- Regulation (EC) No 765/2008, Article 11, and Decision 768/2008/EC, Article R17 — accreditation by national accreditation bodies (under EA-MLA and ILAC) is the preferred basis for designation.
How a Notified Body is designated
Designation is a national competence exercised by a notifying authority — a Ministry or its delegate in each Member State. The process under Decision 768/2008/EC, Articles R17–R23, has four stages:
- Application by the conformity assessment body to the notifying authority, listing the acts and product ranges sought.
- Assessment, typically based on accreditation certificates issued by the national accreditation body under Regulation 765/2008 (the body is assessed against EN ISO/IEC 17065 for product certification, EN ISO/IEC 17021-1 for management systems certification, EN ISO/IEC 17025 for testing, and act-specific competence requirements).
- Notification to the Commission and other Member States via the New Approach Notified and Designated Organisations (NANDO) information system. A four-digit identification number is allocated.
- Objection period — Member States and the Commission may raise objections within prescribed periods. If none is sustained, the designation takes effect.
For the Medical Devices and IVD Regulations, designation involves the additional "joint assessment" procedure under Annex VII MDR, with a team including assessors from other Member States and the Commission. This more stringent procedure has substantially reduced the number of MDR Notified Bodies compared with the predecessor directives.
Scope of designation
A Notified Body's designation is limited to specified acts and product ranges, listed in NANDO. A body designated for the Low Voltage Directive 2014/35/EU cannot perform Module B for machinery under the Machinery Regulation unless separately designated for that Regulation. The product ranges are typically described by reference to standards or by Commission-published classification codes.
Before engaging a Notified Body, a manufacturer must verify on NANDO that:
- The body is currently designated (not withdrawn, suspended, or restricted).
- The designation covers the relevant act.
- The product range listed in the designation includes the product in question.
- The body can perform the specific conformity assessment module required.
Designations are time-limited — typically five years, renewable — and may be restricted, suspended, or withdrawn by the notifying authority following non-conformities found in monitoring (Decision 768/2008/EC, Article R28).
NANDO and the four-digit identification number
NANDO (New Approach Notified and Designated Organisations) is the Commission's official database of Notified Bodies, accessible at ec.europa.eu/growth/tools-databases/nando/. Each Notified Body has a four-digit identification number, unique across all EU acts. Examples (entries verifiable on NANDO):
- 0123 — TÜV SÜD Product Service GmbH (Germany)
- 0344 — DEKRA Certification B.V. (Netherlands)
- 0470 — RISE Research Institutes of Sweden AB
- 0598 — SGS Belgium NV
- 2797 — BSI Group The Netherlands B.V.
Where the Notified Body has been involved in the production-control phase of the applicable conformity assessment module, the four-digit number must be affixed next to the CE mark on the product (Regulation 765/2008, Article 30(4); Decision 768/2008/EC, Annex II per-module provisions). For Module B alone, no number appears on the product — Module B is design-only and must be paired with a production-phase module that determines whether and how the number is shown.
What Notified Bodies do
The work of a Notified Body depends on the conformity assessment module:
- Module B — examine the design and technical documentation, examine specimens of the product, conduct tests, issue an EU type-examination certificate.
- Module C2 / F — examine production samples to verify continued conformity with the type or with the technical documentation.
- Modules D / E / H — assess and approve the manufacturer's quality assurance system, conduct periodic surveillance audits (commonly annual), and reserve the right to unannounced visits.
- Module G — examine each individual product, conduct tests, and issue a per-unit certificate of conformity.
- Module H1 — full quality assurance plus a separate design examination, resulting in an EU design-examination certificate.
Notified Bodies do not issue CE marks. They issue certificates and audit reports. The CE mark is affixed by the manufacturer on the basis of the completed conformity assessment.
Notified Body certificates
Each certificate has a unique number, a validity period, and scope conditions. The EU type-examination certificate under Module B is typically valid for five years (Machinery, Pressure Equipment) to ten years (Radio Equipment), with periodic review by the body. Quality system approval certificates under Modules D, E, H follow the surveillance cycle, with re-certification every three to five years.
Certificates may be amended, restricted, suspended, or withdrawn by the Notified Body if non-conformities are identified during surveillance. Withdrawal of a certificate ends the manufacturer's right to place the affected products on the market until conformity is re-established. The Notified Body must notify the notifying authority and other Member States of any restriction, suspension, or withdrawal (Decision 768/2008/EC, Article R29).
Independence and impartiality requirements
Notified Bodies must be independent of the products they assess. Decision 768/2008/EC, Article R17, requires that the body, its top-level management, and assessment personnel:
- Are not the designer, manufacturer, supplier, installer, purchaser, owner, user, or maintainer of the products they assess, nor the authorised representative of any of those parties;
- Are not engaged in any activity that may conflict with their independence of judgement;
- Receive no remuneration that depends on the results of assessments;
- Maintain confidentiality of information obtained in carrying out their tasks (Article R31), with exceptions for competent authorities.
The same body may, however, certify a product against multiple acts (e.g., LVD + EMC + RED) and may offer non-Notified Body services (testing, training, advisory) provided these are kept structurally separate from conformity assessment.
Choosing a Notified Body
The manufacturer is free to choose any Notified Body designated for the applicable act and product range. There is no geographic restriction — a manufacturer in Italy may engage a Notified Body in Denmark, and the resulting certification is valid across the EEA. Practical considerations:
- Designation scope. Verify on NANDO that the body covers the precise product range and module required.
- Capacity and queue time. Notified Body capacity has been a binding constraint for the MDR (since 2021), the Machinery Regulation (notified-body provisions in force since 14 January 2024), and parts of the Radio Equipment Directive (RED cybersecurity from 1 August 2025). Queue times of 6–18 months for type-examination are not unusual.
- Test laboratory access. Some bodies operate their own labs; others subcontract. Subcontracting is permitted under Decision 768/2008/EC, Article R20, provided the body retains responsibility.
- Language. The technical documentation must be in a language the body accepts. Most bodies accept English; some require national language for parts of the assessment.
Notified Bodies under specific acts in 2026
Notified Body involvement is mandatory in 2026 under:
- Medical Devices Regulation 2017/745 — for all Class IIa, IIb, and III devices (Articles 52–53). MDR-designated bodies number around 50 as of May 2026, against approximately 80 under the predecessor directives.
- In Vitro Diagnostic Regulation 2017/746 — for Class B, C, and D devices.
- Machinery Regulation 2023/1230 — for Annex I machinery where harmonised standards are not applied in full. NB provisions in force since 14 January 2024 ahead of the 20 January 2027 application date.
- Pressure Equipment Directive 2014/68/EU — Categories II, III, IV.
- Lifts Directive 2014/33/EU — typically Modules B + D, B + E, B + F, G, or H1.
- Toy Safety Regulation 2025/2509 — Module B + C for toys not fully covered by harmonised standards (Article 22).
- PPE Regulation 2016/425 — Categories II and III.
- Radio Equipment Directive 2014/53/EU — where harmonised standards are not applied in full, and for the cybersecurity essential requirements introduced by Commission Delegated Regulation (EU) 2022/30.
- Construction Products Regulation 2024/3110 — depending on the Assessment and Verification of Constancy of Performance (AVCP) system applicable to the product family.
Notified Body involvement post-Brexit
UK conformity assessment bodies lost Notified Body status on 1 January 2021. Certificates they had issued ceased to be valid for placing products on the EU market on that date. UK bodies now serve the UK approval scheme as "UK Approved Bodies" under the UKCA framework, which remains optional in Great Britain (see CE marking vs UKCA). EU manufacturers wishing to access the UK regulated market may continue to use CE marking indefinitely under the UK Product Regulation and Metrology Act 2025 for the 21 product regulations covered.
Common errors
- Engaging a Notified Body not designated for the act in question. A body designated for the EMC Directive cannot issue certificates valid for the Radio Equipment Directive even if technically capable. The NANDO scope is binding.
- Citing a body's number without producing the certificate. Affixing "CE 0123" without an underlying Module B / D / E / F / G / H certificate from body 0123 is fraudulent CE marking.
- Treating Notified Body involvement as design approval beyond its scope. A Module B certificate covers the design assessed; it does not extend to subsequent design changes. Changes require a new certificate or, at a minimum, a re-evaluation by the body.
- Ignoring surveillance findings. Where a Notified Body issues a non-conformity report during quality-system surveillance, failure to close it may lead to suspension or withdrawal of the certificate — which immediately invalidates the manufacturer's CE declarations for products covered.
- Mixing Notified Bodies for the same module. For Modules D, E, and H, the same body conducts approval and surveillance. Manufacturers cannot select different bodies for different parts of the cycle.
Relationship to accreditation
Notified Body designation is distinct from accreditation. Accreditation by a national accreditation body (Regulation 765/2008, Article 4) is the technical basis on which a notifying authority typically relies in designating a Notified Body, but accreditation alone does not make a body a Notified Body. A laboratory accredited under EN ISO/IEC 17025 for testing to harmonised standards is not a Notified Body unless designated under a specific act and listed on NANDO.
Sources
- Decision No 768/2008/EC, Articles R17–R34 — EUR-Lex.
- Regulation (EC) No 765/2008, Articles 4 and 30 — EUR-Lex.
- European Commission — NANDO database — ec.europa.eu/growth/tools-databases/nando/.
- Regulation (EU) 2017/745 (MDR), Articles 26–46 and Annex VII — EUR-Lex.
- Commission Notice — Blue Guide 2022, Section 6 — EUR-Lex.