Short answer
A notified body is an independent organisation designated by an EU member state to carry out conformity assessment where the applicable EU directive requires third-party involvement. Select one by verifying its notification scope covers your directive and product category in the NANDO database, then evaluating technical competence, capacity, language, location, and commercial terms.
What is a notified body?
Under the New Legislative Framework, certain conformity assessment modules require the involvement of a third party. That third party is a notified body: a conformity assessment body that a member state has notified to the European Commission as competent for specified legislation and product categories.
Notified bodies conduct activities such as type examination, production quality assurance assessment, and product verification, depending on the module. Their decisions, such as EU type-examination certificates, are recognised across the EEA.
The Commission maintains the NANDO database (New Approach Notified and Designated Organisations), the authoritative public list of notified bodies and their scopes.
When is a notified body required?
Whether a notified body is needed depends on the applicable directive and the conformity assessment module the manufacturer selects. The pattern across directives:
| Situation | Notified body needed? |
|---|---|
| Module A (internal production control) | No, self-assessment |
| Module A1/A2 (internal control plus supervised testing) | Partial, supervised product checks |
| Module B (EU type-examination) plus C/D/E/F | Yes, type-examination by a notified body |
| Module D/E (production/product quality assurance) | Yes, quality system approval |
| Module G (unit verification) | Yes, per-unit verification |
| Module H (full quality assurance) | Yes, design and production QA approval |
Low-risk products under many directives can use Module A without any third-party involvement. Higher-risk categories, or modules the manufacturer selects for commercial reasons, require a notified body.
How to verify a notified body scope
- Open the NANDO database and search by directive and country, or by body name.
- Open the body entry and read its notification scope: the directives and the product categories or conformity assessment procedures it is notified for.
- Confirm the scope covers your specific directive and the module you intend to use.
- Check the notification is current and not suspended or withdrawn.
A body notified for the EMC Directive cannot assess under the Machinery Regulation unless separately notified for it. Scope precision matters.
How to evaluate candidates
Beyond scope, assess:
* Technical competence. Experience with your product technology and the applicable standards. Ask for relevant references. * Capacity and timing. Certification lead times vary significantly. Confirm the body can meet your schedule. * Language. The assessment will generate findings and certificates. Confirm working language compatibility. * Location and logistics. Testing may require shipping products or hosting audits. Factor in geography. * Commercial terms. Fee structures differ: fixed project fees, daily rates, annual surveillance charges. Obtain written quotations. * Accreditation. Notification is the legal status; accreditation to ISO/IEC 17065 or 17025 supports confidence in technical quality.
What does the engagement look like?
A typical type-examination engagement:
- Application with product description and technical documentation
- Documentation review by the notified body
- Testing, either at the body laboratory or a recognised facility
- Evaluation and decision
- Issue of the EU type-examination certificate
- Ongoing surveillance where the module requires it, such as periodic audits under Module D
The manufacturer retains full responsibility for conformity. The notified body certificate is evidence within the technical file, not a transfer of liability.
Common selection mistakes
* Choosing by price alone. The cheapest body with the longest lead time can delay market entry by months. * Assuming scope. A body well known in one directive may lack notification for yours. * Ignoring surveillance costs. Modules with ongoing audits carry annual charges that should be budgeted from the start. * Late engagement. Involving the body after design freeze risks costly redesign if findings emerge.
Checklist: notified body selection
* [ ] Confirm a notified body is actually required for your directive and module * [ ] Verify candidate scope in NANDO for your directive and product category * [ ] Check notification status is current, not suspended * [ ] Evaluate technical experience with your product technology * [ ] Confirm capacity and lead times against your launch plan * [ ] Obtain written quotations including surveillance charges * [ ] Agree working language and documentation format upfront
What happens during the assessment itself?
Understanding the assessment process helps manufacturers prepare and avoid delays:
Documentation review. The notified body examines the technical documentation for completeness and coherence before testing begins. Gaps identified here pause the process until resolved. A well-structured file shortens this phase significantly.
Testing. Depending on the module, the body tests samples itself, witnesses testing, or reviews test reports from recognised laboratories. The test plan follows the applicable harmonised standards and the essential requirements.
Evaluation. The body evaluates whether the evidence demonstrates conformity. Findings are communicated as non-conformities requiring correction, observations for improvement, or acceptance.
Decision and certification. On satisfactory evaluation, the body issues the relevant certificate or decision: EU type-examination certificate, quality system approval, or product verification as applicable.
Surveillance. Modules involving quality assurance include ongoing surveillance: periodic audits and sometimes unannounced visits. Budget for these as recurring costs.
How do you manage the relationship over the product lifecycle?
The notified body relationship extends beyond the initial certificate:
* Inform the body of design changes that could affect conformity; the certificate may need amendment * Prepare for surveillance audits with the same rigour as the initial assessment * Track certificate validity and renewal dates; expired certificates cannot support ongoing production * If switching bodies, plan the transfer: the new body must satisfy itself of conformity, which takes time
Treat the notified body as a long-term technical partner rather than a one-time vendor. Continuity of the assessment team improves efficiency across product generations.
What are the alternatives to notified body involvement?
Where the directive permits self-assessment modules, manufacturers may avoid notified body involvement entirely. This is common for lower-risk products under Module A.
The trade-off is responsibility: self-assessment places the full burden of demonstrating conformity on the manufacturer, with no third-party validation. For complex products or novel technologies, voluntary engagement of a body, even where not required, can strengthen the file and commercial credibility.
Some manufacturers use a hybrid: self-assessment for the initial placing on the market, with a notified body engaged for specific aspects such as radio testing under the Radio Equipment Directive where the harmonised standards do not fully cover the requirements.
How do fees and timelines compare?
Notified body engagement involves costs and scheduling that should be understood before commitment:
Fee structures vary by body and product complexity. Typical components include application fees, documentation review, testing charges, certification fees, and ongoing surveillance costs. Obtain a detailed quotation breaking down each element rather than a single figure.
Timelines depend on the body workload, the product complexity, and the quality of the submitted documentation. A complete, well-organised file moves faster. Bodies with sector specialisation in the product area are typically more efficient because their assessors know the standards and failure modes.
Retesting risk. If testing reveals non-conformities, the timeline extends by the redesign and retest cycle. Budget contingency for at least one round of findings on novel products.
When comparing bodies, evaluate the total cost of the relationship over the certificate lifecycle, including surveillance, rather than just the initial certification fee. A lower initial fee with expensive surveillance may cost more overall.
What should the contract with the notified body cover?
The engagement terms should address:
* The scope of the assessment: which directives, which modules, which product models * The deliverables: certificates, reports, and their format * The timeline commitments and the assumptions behind them * The fee structure and payment terms, including charges for additional work * Confidentiality protections for the technical documentation * The process for handling non-conformities and reassessment * Suspension and withdrawal conditions for certificates * The transfer provisions if the relationship ends
Review the body standard terms rather than assuming they match commercial norms. Notified bodies operate under accreditation constraints that affect their flexibility on some points.
How do you handle disagreements with assessment findings?
Disagreements arise, particularly on novel products where the standards allow interpretation. The constructive approach:
* Understand the finding. Ask the assessor to explain the requirement and the evidence gap precisely. Many disagreements dissolve when the finding is clarified. * Provide additional evidence. If the finding reflects missing evidence rather than actual non-conformity, supply it. * Present technical argument. Where the interpretation is genuinely debatable, present a reasoned technical case with supporting references. * Use the body complaints process. Accredited bodies have formal processes for disputing findings. * Seek a second view. In persistent disagreements, another body assessment or independent expert opinion can clarify the position.
Maintain a professional relationship throughout. The assessor is applying the requirements as they understand them; adversarial approaches rarely improve outcomes.
How does accreditation constrain what bodies can do?
Notified bodies operate under accreditation and notification that define their scope precisely. Understanding the constraints helps manufacturers set expectations:
* A body can only assess within its notified scope: the directives and product categories for which it is designated * The body must maintain impartiality; it cannot consult on the design it will assess * Assessment decisions must be made by competent personnel meeting the qualification requirements * The body is subject to surveillance by its notifying authority and can have its notification restricted or withdrawn
If a body notification is withdrawn while assessments are in progress, the manufacturer must transfer to another body. Certificates issued by a body that later loses notification remain valid for products already placed on the market, but ongoing production needs a new assessment arrangement.
Check the NANDO database not just at selection but periodically during long product lifecycles.
Sources
* EU NANDO database: https://single-market-economy.ec.europa.eu/single-market/goods/nando_en * Decision No 768/2008/EC: https://eur-lex.europa.eu/eli/dec/2008/768 * The Blue Guide on EU product rules: https://single-market-economy.ec.europa.eu/docs/single-market/goods/blue-guide_en