Choosing a Laboratory · Notified Bodies

What Is a Notified Body and When Does My Product Need One?

A notified body is a designated third-party assessor - involved in some CE routes and absent from most. What it is, when EU law requires one, and when a test report plus a signed declaration is enough.

← All guides Compliance documents and a shipped product prepared for conformity assessment in the European market

Sooner or later someone in your supply chain asks for a "notified body certificate". Sometimes it is a European buyer half-remembering a rule. Sometimes it is an importer protecting itself, or a quotation that suddenly lists an EU-type examination nobody budgeted for. The usual reaction is to nod and forward the email - which is how products end up either paying for an assessment the law never required, or shipping without one it did need.

The confusion exists because that one term bundles three separate questions: what a notified body is, when European law forces one into your project, and when a test report plus a signed declaration is enough. Keep them apart and the decision is mostly mechanical. Mix them up and it gets expensive.

What a notified body actually is

A notified body is an organisation that an EU member state has assessed, designated and notified to the European Commission to carry out defined third-party conformity assessment tasks under specific EU product legislation. Every designation is listed in the Commission's NANDO database - New Approach Notified and Designated Organisations, now hosted in the Commission's Single Market Compliance Space - and each body carries a four-digit identification number.

Two details matter more than the definition itself.

First, a designation is not a blanket licence. It is granted act by act, module by module, and frequently product family by product family. A body notified for EU-type examination under the Radio Equipment Directive is not automatically entitled to assess machinery or medical devices, and a body whose notification has been suspended or withdrawn cannot issue legally valid certificates while it stays off the list.

Second, a notified body is not a test laboratory. Many notified bodies own laboratories, and many ISO/IEC 17025 accredited laboratories are not notified bodies. A test report is a measurement record; an EU-type examination certificate is a legal act with a defined role inside a directive. For the United Kingdom the term changes to Approved Body and the rules differ again - that split is covered in our article on CE and UKCA marking.

Four documents that all get called a "notified body certificate"

When a buyer or platform uses the phrase, it can refer to any of four documents. They are not interchangeable, and working out which one is being asked for is half the answer:

What you are handedIssued byWhat it actually is
Test reportA testing laboratoryMeasured results against standards. Evidence, but no legal status on its own.
EU Declaration of ConformityThe manufacturerThe legally required statement that the product meets the applicable directives. Never the notified body's document.
EU-type examination certificate (Module B)A notified bodyThe notified body examined the technical documentation and approved the design type. Mandatory in specific cases, optional in others.
Voluntary product certificateAny certification bodyA commercial document. It proves nothing under EU law.

Notice what the table does not say: that the notified body takes over responsibility. It never does. Whoever signs the EU Declaration of Conformity remains legally responsible for conformity. The notified body's role is specific, defined by the directive, and limited to the procedure it was designated for.

When the law actually requires a notified body

For most electronics the honest answer is: it does not. The directive decides - not the buyer, not the laboratory, and not habit.

Under the EMC Directive 2014/30/EU, Article 14 offers two routes and the manufacturer chooses between them. Internal production control (Annex II) involves no notified body and is what nearly every EMC-only product uses. EU-type examination followed by conformity to type (Annex III) is an option - typically where harmonised standards were not applied in full and the manufacturer wants third-party confirmation of the EMC assessment. The Low Voltage Directive is structured the same way: self-assessment against harmonised standards is the normal route, with EU-type examination available as an option.

The Radio Equipment Directive 2014/53/EU is where it becomes conditional, because Article 17 splits the assessment by requirement:

Outside the electronics directives, several product families require a notified body by risk class - machinery, certain toys, category II and III personal protective equipment, medical devices, equipment for potentially explosive atmospheres, measuring instruments. If your product sits in one of those families, the question is not whether a notified body is needed but which one and under which procedure.

The Article 3(2) trigger catches teams in a specific way. A Bluetooth-only product assessed fully against EN 300 328 self-declares without difficulty. Add a proprietary sub-GHz mode and the picture can change: EN 300 220 exists for short-range devices in that range, but if the implementation behaves in ways the standard does not cover - so the assessment can only be applied in part - the spectrum requirement moves to the notified body route. The product did not become riskier. The legal route changed because the assessment can no longer be closed with a cited harmonised standard alone.

The 2025 change that pulled connected products into the notified body route

Since 1 August 2025, the cybersecurity requirements activated under Article 3(3)(d), (e) and (f) of the RED - network protection, personal data and privacy, fraud prevention - have applied to internet-connected radio equipment, child-care and wearable radio equipment, and equipment processing virtual money, under Commission Delegated Regulation (EU) 2022/30. The harmonised standards for these requirements, EN 18031-1, -2 and -3:2024, were cited in the Official Journal on 28 January 2025 - with restrictions.

The restrictions are the practical problem. EN 18031-1 does not confer a presumption of conformity, for example, where the user is allowed not to set and use a password, and EN 18031-2 loses it where parental or guardian access control is not ensured for the device classes concerned. Where a restriction bites, or the manufacturer does not apply the standard in full, Article 17(4) sends that requirement to EU-type examination by a notified body.

A connected product team we reviewed in 2025 had listed EN 18031-1 in its technical file while the companion app still allowed skipping password setup entirely. On paper the standard was applied. Under the Official Journal restrictions, the presumption of conformity for Article 3(3)(d) was gone. The realistic options were a firmware change or an EU-type examination - and the earlier such a gap is caught, the cheaper either one is.

Since mid-2025 this has been the most common reason a formerly self-declared Wi-Fi product suddenly needs a notified body. The hardware did not change. The scope of the legal assessment did.

The four-digit number next to the CE marking

Buyers read more into that number than it carries. Under the RED, Article 20(3) is precise: the CE marking is followed by the notified body's identification number where the conformity assessment procedure in Annex IV - full quality assurance - is applied. That is the only case in the directive. A product assessed through EU-type examination plus Module C carries a plain CE marking with no number, and under the EMC Directive no module involves the notified body in production, so no number ever appears there either.

Three consequences follow. The absence of a number is not evidence of non-compliance. A number does not identify which certificate covers the product - it identifies which body participated. And the artwork is not yours to decorate: the number must match the height of the CE marking and is affixed by the notified body itself or under its instructions. We have had to talk two customers out of adding digits to their label artwork because a buyer insisted - a change their technical file could not support.

If a notified body is in your future, check these before committing

  1. Scope in NANDO. Look up the four-digit number and confirm that the act, the module and the product range are all covered, and that the notification is current rather than suspended or withdrawn.
  2. The legal entity. Subsidiaries of the same group are notified separately. The certificate must come from the notified legal entity, not an affiliate.
  3. One application. Annex III and Annex IV both require a written declaration that the application has not been lodged with another notified body.
  4. The approved type. The certificate covers the design as examined. A new antenna, an added radio mode or firmware changes to RF behaviour are changes to the approved type - they need the body's assessment, and that conversation is far cheaper before the design is frozen.
  5. Timeline. EU-type examination is document review plus evidence, not bench time. It moves slower than a test programme and notified bodies have queues. Start before the buyer's deadline, not after it arrives.
  6. A split scope. Under the RED you can keep self-declaring safety and EMC while the spectrum or Article 3(3) requirement goes through a body - and different requirements may use different notified bodies. The quotation should make that split visible instead of bundling everything into one line.

Those checks sit next to the ones that matter when picking a laboratory in the first place - six checks before you commit to a testing laboratory covers them separately.

Where we fit in

SZC-LAB is a test laboratory, not a notified body, and we say that early because it shapes the plan. What we do is the work on both sides of the notified body's task: determining whether your product legally needs one at all, building the test evidence and technical documentation the EU-type examination will be judged on, and coordinating with the body so the examination reviews your file instead of discovering its gaps. Most projects never touch the notified body route. The ones that do go better when the testing is planned around it from the start, rather than treated as a separate universe that appears after the report. Our testing and certification services cover both the self-declaration route and the evidence package a notified body route requires.

If a buyer is asking for the certificate

If you cannot tell whether a product legally needs a notified body, send us the product description, the radio modes and bands it uses, and the exact wording of the requirement you were given. We will tell you which requirements stay self-declared, which - if any - must go through EU-type examination, and what the notified body will expect to see. That turns a vague buyer demand into a specific answer you can defend.

Send the product and the requirement wording

If a buyer has asked for a notified body certificate and you cannot tell whether the product legally needs one, send the product description, the radio modes and bands it uses, and the exact wording of the requirement you were given. We will tell you which requirements stay self-declared, which - if any - must go through EU-type examination, and what the notified body will expect to see, so you can answer the buyer with the directive behind you.

Send the product and the requirement wording

Frequently asked questions

Is a notified body the same as an accredited test laboratory?

No. A laboratory tests products and issues reports. A notified body is designated by an EU member state to perform defined conformity assessment tasks, and its designations are listed in the Commission's NANDO database. Many notified bodies run laboratories, but accreditation alone does not make a laboratory a notified body.

Does every CE-marked product need a notified body number after the CE marking?

No. Under the Radio Equipment Directive the number appears only where the Annex IV full quality assurance procedure is used. Products assessed through EU-type examination plus Module C, and all products under the EMC Directive, carry a plain CE marking.

Is self-declaration legal for a Bluetooth or Wi-Fi product?

Yes, where the harmonised standards covering each applicable requirement are applied in full - including the newer Article 3(3) cybersecurity requirements. If a cited standard is applied only in part, or the Official Journal listing carries a restriction the product does not meet, that requirement moves to an EU-type examination by a notified body.

How do I check whether a certificate came from a real notified body?

Take the four-digit number and look it up in the Commission's NANDO database. Confirm the body is currently notified and that its notification covers the directive, the module and the product range on the certificate. A certificate issued by a body outside its designated scope has no legal effect.

Can we keep self-declaring part of the product while a notified body handles the rest?

Under the RED, yes. Safety and EMC can stay on internal production control while the spectrum or Article 3(3) requirement goes through EU-type examination, and different requirements may even use different notified bodies.

Does involving a notified body transfer responsibility for compliance?

No. The manufacturer still draws up and signs the EU Declaration of Conformity and remains responsible for conformity. The notified body's role is limited to the procedure the directive assigns it.

WhatsApp
WeChat ID copied!