"Do we need to apply to a notified body?" is one of the most confusing and most cost-driving points in the CE process. Some manufacturers enter this process unnecessarily and lose time and budget, while others who actually need it skip this step and end up unable to place their products on the market at all. In this article we cover in detail what a notified body is, when it comes into play, how it is selected, and how it differs from accredited test laboratories.
The Notified Body Concept and Its Role in the CE Process
A notified body is an independent body designated by an EU member state to carry out conformity assessment activities under specific product directives or regulations, with that designation formally notified to the European Commission. These bodies are listed in the Commission's NANDO (New Approach Notified and Designated Organisations) database, with the specific directive, product category and conformity assessment module for which they are authorized clearly stated. For a body to be referred to as a "notified body," it must have gone through this formal notification process; not every body that presents itself this way is actually authorized, which is why verifying the NANDO registration is a critical step.
The logic underlying CE legislation is that, for most products, the manufacturer's own declaration (self-declaration) is relied upon. However, Decision No 768/2008/EC — one of the cornerstones of the New Legislative Framework — defines a modular system in which an independent third party becomes involved as risk level increases. Which of these modules applies is defined in the directive and the relevant annex governing the product. You can find more information on the general workings of the CE process in our article What Is CE Certification?, and on which products fall within CE scope in Who Is Required to Have CE Certification?.
In Which Cases Is a Notified Body Mandatory?
Notified body involvement is mandatory not for all products, but only for the high-risk categories explicitly required by the relevant directive. In Machinery Directive 2006/42/EC, these categories are listed one by one in Annex IV: for example, certain woodworking machines, certain presses with closed dies, and portable cartridge-operated fixing and other impact machines. Under Regulation (EU) 2016/425 on personal protective equipment, category III (equipment protecting against mortal danger or irreversible health damage) requires notified body involvement. In pressure equipment, certain categories under PED 2014/68/EU, and in medical devices, class IIa and above under the Medical Device Regulation (MDR), are typical examples. For the specific requirements of such high-risk machinery, our article What Is Partly Completed Machinery? may also be of interest.
By contrast, the vast majority of products under the Low Voltage Directive (LVD) do not require notified body involvement; the manufacturer can carry out its own testing and proceed via self-declaration. Under the Radio Equipment Directive (RED), notified body involvement may arise under certain articles (Article 3.2) related to whether the product uses the radio frequency spectrum effectively and efficiently, and in some special cases.
What Does a Notified Body Actually Do?
What a notified body concretely does depends on the conformity assessment module chosen. One of the most common practices is "EU-type examination" (Module B): the manufacturer submits a product sample and the technical file to the notified body; the body examines the product's compliance with the relevant essential requirements, requests additional tests if necessary, and if satisfied, issues an "EU-type examination certificate." In other modules (for example, Module D - production quality assurance, Module H - full quality assurance), the notified body audits the manufacturer's quality management system rather than the product itself, and confirms through periodic surveillance audits that this system continues to operate reliably. In Module G (unit verification), each individual product unit is examined separately; this is generally used for special-purpose or one-off equipment.
What Is the Notified Body Number For?
For a product requiring notified body involvement, the body's four-digit identification number from the NANDO database is printed right next to the CE mark, at the same height. This number makes the identity and accountability of the independent body that examined the product visible; when market surveillance authorities detect an issue, they can trace it back to the relevant certificate and body through this number. We covered the general rules for using the CE mark in our article How Is the CE Mark Read?.
Difference Between a Notified Body and an Accredited Test Laboratory
These two concepts are frequently confused in practice. An accredited test laboratory is a body that has obtained its competence to carry out measurements and tests according to a specific standard (for example, the relevant EN standard series for certain test types) from a national accreditation authority (such as TÜRKAK in Türkiye); its output is a test report. A notified body, on the other hand, is a body designated by an EU member state to carry out conformity assessment under a specific directive and notified to the Commission; its output is generally a certificate. Some large bodies can hold both accredited laboratory and notified body status at the same time, but these two authorizations are assessed separately and must be verified separately. See our article When Are Tests Required in the CE Process? for the place of laboratory testing in the CE process.
How Is a Notified Body Selected?
Choosing the right notified body directly affects the speed and quality of the process. First, it needs to be verified in the NANDO database that the body is genuinely designated for the directive your product is subject to, and for the specific product category within that directive; a body being generally "a notified body" does not mean it is authorized for every product group. Next, practical factors such as the body's experience in your sector, typical file review turnaround times, communication language and process transparency should be assessed.
Relevant Directives and Standards
The legal basis of the notified body system is Decision No 768/2008/EC, which defines the conformity assessment modules, and Regulation No 765/2008/EC, which sets out market surveillance and the general rules of CE marking. The main legislation under which notified body involvement may arise, by product: Annex IV of Machinery Directive 2006/42/EC (and Machinery Regulation (EU) 2023/1230, which will gradually replace it from 20 January 2027), Regulation (EU) 2016/425 for personal protective equipment, PED 2014/68/EU for pressure equipment, Directive 2014/33/EU for lifts, MDR (EU) 2017/745 for medical devices, and in certain cases the Radio Equipment Directive 2014/53/EU. By contrast, the vast majority of products under Low Voltage Directive 2014/35/EU proceed via the self-declaration model.
| Module | Name | Notified Body's Role |
|---|---|---|
| Module A | Internal production control | None; relies entirely on manufacturer's declaration |
| Module B | EU-type examination | Examines the product sample and technical file, issues a type-examination certificate |
| Module C2 | Internal production control + supervised product checks | Carries out product checks at random intervals |
| Module D | Production quality assurance | Audits the manufacturer's quality system during production |
| Module G | Unit verification | Examines each individual product unit separately |
| Module H | Full quality assurance | Audits the entire quality system, including design and production |
Step-by-Step Process
- Clarify the directive your product is subject to and the scope of its annex; determine whether a notified body is required.
- If required, identify the applicable conformity assessment module (B, D, G, H, etc.).
- From the NANDO database, list the notified bodies genuinely designated for your product category.
- Get proposals, process flows and estimated timelines from the shortlisted bodies.
- Prepare your technical file and required test reports in the format the notified body will request.
- Submit your application and provide any additional information or tests requested during the body's review in a timely manner.
- If a certificate is issued following the review, record the certificate number correctly in your technical file and on your CE mark.
- For modules such as D or H that require ongoing audits, add periodic surveillance audits to your calendar.
Most Common Mistakes
- Signing an agreement without verifying whether the body is genuinely designated in NANDO for the relevant product category.
- Assuming an accredited test laboratory has the same authority as a notified body.
- Applying to a notified body unnecessarily and losing time and cost as a result.
- Affixing the CE mark via self-declaration without ever applying to a notified body when it was actually required.
- Using the notified body number incorrectly, missing, or in the wrong size or position on the CE mark.
- Failing to track periodic audits in processes such as Module D/H that require ongoing surveillance.
- Changing the product design after obtaining a type-examination certificate without informing the body.
- Assuming notified bodies in different countries have identical authority and skipping the scope check.
Frequently Asked Questions
Is notified body approval required for every product?
No. The vast majority of products carry out CE marking through self-declaration. Notified body involvement is mandatory only for the high-risk product categories explicitly listed in the annex of the relevant directive.
Are a notified body and an accredited test laboratory the same thing?
No. An accredited laboratory is a body that has obtained its competence to perform measurements and tests according to specific test standards from an accreditation authority. A notified body is a body designated by an EU member state to carry out conformity assessment under specific directives and formally notified to the European Commission. Some bodies can carry out both functions at once, but conceptually they are different.
Where can I see a notified body's identification number?
Every notified body has a four-digit identification number published in the NANDO database. On products where its involvement is required, this number is printed right next to the CE mark, at the same height.
Can more than one notified body be involved for a single product?
Yes, this is possible if the product falls within the scope of more than one directive and a different notified body is chosen for each directive, but since this complicates process management, it is usually preferred to run the entire scope with a single body.
What should be considered when choosing a notified body?
It is important to verify in the NANDO database that the body is genuinely designated for your product's relevant directive and scope, and to assess its past sector experience, file review turnaround time and clarity of communication.
Does a notified body certificate have a validity period?
Yes, EU-type examination certificates are usually issued for a specific period (often five years), and a reassessment or surveillance audit is required at the end of that period. The period and conditions may vary depending on the chosen body and module.
Does the notified body review the entire technical file?
Generally no; the notified body reviews the elements that fall within the scope of the module it is designated for (for example, the type-examination file, test reports, or the quality management system). Preparing the complete technical file remains the manufacturer's responsibility.
What happens if the notified body rejects the application?
If the notified body determines that the product does not meet the relevant requirement, it does not issue a certificate and notifies the manufacturer of its reasons. The manufacturer can reapply after addressing the identified deficiencies, or turn to a different notified body.
How much does the notified body process extend the CE timeline?
This varies depending on the product's complexity, file quality and the body's current workload; it can take anywhere from a few weeks to a few months. For factors affecting overall CE process timelines, see our article How Long Does It Take to Get CE Certification?
Is there a notified body in Türkiye?
Under EU legislation, "notified body" status is designated by EU member states and listed in the NANDO database. While some bodies in Türkiye carry out a similar function under certain regulations using the term "notified body," when it comes to exporting to the EU, you need to work with a body registered in NANDO for your product's scope.
In which cases is notified body involvement definitely mandatory?
Notified body involvement is directly mandated by legislation in areas such as certain high-risk machinery categories listed in Annex IV of the Machinery Directive, category III personal protective equipment, certain pressure equipment classes, and many classes of medical devices.
Conclusion
A notified body is an independent conformity assessment authority that comes into play not for every CE product, but only in the high-risk categories explicitly required by legislation. Correctly identifying this need from the outset prevents both unnecessary cost and the legal risk of skipping a mandatory step. Verifying the right body through NANDO and fully meeting the requirements of the selected module is the key to a smooth process.
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