What is a Notified Body?
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, which follows the CE mark on a product where the body took part in production control.
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, Category I PPE, toys fully covered by harmonised standards), no Notified Body is involved and the manufacturer declares conformity itself, usually under Module A.
Do you need a Notified Body?
Work through three questions:
- Which acts apply? Use the product checker or does my product need CE marking? A product can fall under several acts, and each is assessed separately.
- Which category or class is the product in? Most sectoral acts tie the route to risk: PPE categories, pressure equipment categories, medical device classes, the machinery lists in Annex I.
- Did you apply harmonised standards in full? Under several acts this decides the route. Under the RED, the Toy Safety rules and Annex I Part B of the Machinery Regulation, full application lets you avoid third-party assessment; partial application, or a citation with an applicable restriction, brings a Notified Body in.
| Act | Notified Body needed? |
|---|---|
| Low Voltage Directive 2014/35/EU | No. Module A only. |
| EMC Directive 2014/30/EU | Not required. Module A, or Modules B + C if the manufacturer chooses them. |
| Radio Equipment Directive 2014/53/EU | Only where harmonised standards are not applied in full, including for the cybersecurity requirements activated by Delegated Regulation (EU) 2022/30. |
| Machinery Regulation 2023/1230 | From 20 January 2027: always for the six Annex I Part A categories; for Annex I Part B where harmonised standards or common specifications are not applied in full. Directive 2006/42/EC governs until then (see the transition guide). |
| Toy Safety Regulation 2025/2509 | Modules B + C where harmonised standards or common specifications do not cover all relevant requirements or are not fully applied (Article 26), from 1 August 2030. Until then EC type-examination under Directive 2009/48/EC applies in comparable cases. |
| PPE Regulation 2016/425 | Category I: no. Category II: Modules B + C. Category III: Module B + C2 or D. |
| Pressure Equipment Directive 2014/68/EU | Category I: no (Module A). Categories II, III and IV: yes. |
| Medical Devices Regulation 2017/745 | Class IIa, IIb and III: yes. Class I: no, except devices placed on the market sterile, with a measuring function, or reusable surgical instruments, where the body's role is limited to those aspects (Article 52(7)). |
| IVD Regulation 2017/746 | Class B, C and D: yes. Class A: no, unless placed on the market sterile (Article 48). |
| Gas Appliances Regulation 2016/426 | Yes. Module B with C2, D, E or F, or Module G for single units or small quantities (Article 14). |
| Lifts Directive 2014/33/EU | Yes. Every procedure in Articles 15 and 16 involves a Notified Body; the directive uses its own procedures for lifts and for safety components. |
| Construction Products Regulation 2024/3110 | Depends on the assessment and verification of constancy of performance (AVCP) system for the product family. |
Worked examples
- Mains-powered desk lamp. LVD and EMC, both self-declared. No Notified Body, and the CE mark stands alone with no number. A test report from a laboratory may support the file but is not a Notified Body assessment.
- Category II PPE. Module B + C. A Notified Body issues the EU type-examination certificate, but production is under the manufacturer's internal control, so no number follows the CE mark even though a body was involved.
- Fall-arrest harness (Category III PPE). Module B followed by C2 or D. A body takes part in the production phase and its number follows the CE mark. It need not be the body that issued the Module B certificate.
Legal basis
- Decision No 768/2008/EC, Articles R13–R30 (designation, monitoring, operational obligations of Notified Bodies). These reference provisions are the template for the aligned sectoral acts.
- Sectoral acts add specific requirements — e.g., Articles 35–50 and Annex VII of Regulation (EU) 2017/745 (MDR) set out a far more detailed Notified Body framework, including the joint assessment of applicants under Article 39.
- Decision No 768/2008/EC, Article R12(3) — the Notified Body identification number follows the CE mark when the body has been involved in the production-control phase.
- Regulation (EC) No 765/2008, Chapter II, and Decision 768/2008/EC, Articles R22–R23 — accreditation by a national accreditation body is the preferred way of showing competence (Blue Guide, section 5.3), but a body may instead submit documentary evidence.
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 R13–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 — the body may act as a Notified Body only if the Commission and the other Member States raise no objection within two weeks where an accreditation certificate is used, or two months where it is not (Article R23(5)).
For the Medical Devices and IVD Regulations, designation involves an additional joint assessment (Articles 38–39 MDR) by a team including Commission and Member State experts, against the requirements in Annex VII MDR.
Scope of designation
A Notified Body's designation is limited to specified acts and product ranges, listed in NANDO. A body designated for the EMC Directive 2014/30/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 body, check that its notification covers your act, your product and the module you need. The steps are in how to search NANDO.
The reference provisions set no fixed term for a notification. The Blue Guide (section 5.3.4) says NANDO entries should be updated at least every five years with information on continued monitoring, and a notifying authority must restrict, suspend or withdraw a notification where the body no longer meets the requirements (Decision 768/2008/EC, Article R25).
The four-digit identification number
The Commission assigns each Notified Body one identification number, even where it is notified under several acts (Decision 768/2008/EC, Article R24). The number identifies the body, not the product or the certificate. To find out who a number belongs to, use the CE number lookup; to search for a body by act or country, see the NANDO database guide.
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 (Decision 768/2008/EC, Article R12(3), and the per-module provisions of Annex II). 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 validity of an EU type-examination certificate is set by the applicable act or, where the act is silent, by the body: for example, a maximum of five years under the Machinery Regulation (EU) 2023/1230 (Annex VII) and the PPE Regulation (EU) 2016/425 (Annex V), ten years, renewable, under the Pressure Equipment Directive 2014/68/EU (Annex III, Module B), and a maximum of five years for certificates under the Medical Devices Regulation (Article 56(2)). The Radio Equipment Directive sets no fixed period. The Commission's proposal of December 2025 to revise the MDR and IVDR is still in the legislative process, so the current rules apply until an amendment is adopted. Quality system approvals under Modules D, E and H are maintained through the body's periodic surveillance audits.
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 inform its notifying authority of any refusal, restriction, suspension, or withdrawal, and give other bodies notified for similar activities relevant information on negative results (Decision 768/2008/EC, Article R28).
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;
- Are paid in a way that does not depend on the number or results of assessments, as regards top-level management and assessment personnel (Article R17(8));
- Maintain confidentiality of information obtained in carrying out their tasks (Article R17(10)), with exceptions for competent authorities.
The same body may certify a product against several acts (e.g., EMC + RED) and may carry on other activities, but it must have procedures that distinguish its notified-body tasks from those activities (Article R17(6)). Article R17(4) singles out consultancy: a body must not advise on the products it assesses.
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, a manufacturer outside the EU may engage either, 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. Capacity has been a recurring concern under the MDR, and demand can rise before new rules apply, as with the RED cybersecurity requirements (from 1 August 2025) and the Machinery Regulation (notified-body provisions applicable since 20 January 2024). Ask for a lead time before you commit to a launch date.
- Test laboratory access. Some bodies operate their own labs; others subcontract. Subcontracting is permitted under Decision 768/2008/EC, Article R20, provided the client agrees and the body retains full 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 Body involvement post-Brexit
UK conformity assessment bodies lost Notified Body status on 1 January 2021. From that date their certificates no longer supported placing products on the EU market, unless the file had been transferred to an EU Notified Body. 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). Manufacturers supplying Great Britain may continue to rely on CE marking for the 21 product regulations covered by the Product Safety and Metrology etc. (Amendment) Regulations 2024, in force since 1 October 2024; medical devices are handled separately.
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 improper use of the 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 removes the basis for continuing to declare conformity for the 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 that cycle. The Module B body and the production-phase body, by contrast, need not be the same.
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.
Frequently asked questions
Does every CE-marked product need a Notified Body?
No. Most products under the Low Voltage and EMC Directives, Category I PPE and machinery outside Annex I are self-declared by the manufacturer. A Notified Body is needed only where the applicable act requires third-party assessment for that product or route.
Is a Notified Body a government agency?
No. Most are private companies. A Member State authority assesses and notifies them, and the Commission lists them, but they are not EU institutions or Commission agencies.
Does a Notified Body issue the CE mark?
No. It issues certificates and reports. The manufacturer, or its authorised representative under a mandate, affixes the CE marking and takes responsibility for conformity.
Is a test report from an accredited laboratory the same as a Notified Body certificate?
No. Accreditation alone does not make a laboratory a Notified Body. Its report may support your technical documentation, but it does not replace an assessment that the act reserves to a Notified Body.
Can a manufacturer outside the EU use a Notified Body?
Yes. Notified Bodies may offer their services to operators inside or outside the Union, within the scope of their notification. The body itself must be established in the Member State that notified it, or be recognised under an international agreement.
Sources
- Decision No 768/2008/EC, Articles R13–R30 — 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 35–56 and Annex VII — EUR-Lex.
- UK Department for Business and Trade — Continued recognition of EU requirements, including CE marking.
- Commission Notice — Blue Guide 2022, Sections 4.5.1, 5.2, 5.3 and 6 — EUR-Lex.