Notified body: when you need one and how to find it

A notified body is an independent organisation that an EU country has designated to carry out the checks a product law hands to a third party. You need one only where your product’s law says so. The low-voltage Directive has no procedure that requires one; under the toy, machinery, protective-equipment and medical-device laws you need one in the cases the table below sets out (Your Europe: “A notified body is an independent organisation authorised by an EU country to assess product compliance when required by legislation”).

What you do:

1. Find the conformity assessment article of the EU law that covers your product. The table below gives it for the laws online sellers meet most. It says whether you assess the product yourself or a notified body must.
2. If the law lets you assess the product yourself, you need no notified body. You draw up the technical documentation, sign the declaration and affix the marking, as in CE marking and the declaration of conformity.
3. If the law requires a notified body, or you choose a route that includes one, search the Commission’s NANDO database by your law and pick a body notified for the exact procedure you need.
4. Apply to one notified body for that procedure; the application carries a written declaration that it has not been lodged with any other notified body (Decision No 768/2008/EC, Annex II, Module B, point 3). For medical devices the manufacturer “may not lodge an application in parallel with another notified body for the same conformity assessment procedure” (Art. 53(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 53, paragraph 1Click opens the article on EUR-Lex.).
5. Put the body’s four-digit number after the CE marking where your law asks for it: under the general rule, where the body took part in the production phase (Decision No 768/2008/EC, Art. R12(3)).
6. Name the body in the EU declaration of conformity (Decision No 768/2008/EC, Annex III, point 7) and keep a copy of its certificate with the technical documentation, usually for 10 years after the product is placed on the market. Your law may set longer (Decision No 768/2008/EC, Annex II, Module B, point 9; Art. 10(8)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 8Click opens the article on EUR-Lex. sets at least 15 years for implantable devices, and Directive 2006/42/EC, Annex X, point 4, counts ten years from the last date of manufacture).

A notified body is an independent body that an EU country has designated

A notified body is a conformity assessment body, meaning a body that tests, certifies or inspects, that an EU country has officially designated to carry out conformity assessment under a product law where a third party is required (Blue Guide, section 5.2.1; Art. 2(13)Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)Article 2, point 13Click opens the article on EUR-Lex.). The country tells the Commission and the other EU countries. Only a body that went through that notification counts as one: “Only such a body shall be considered a notified body” (Decision No 768/2008/EC, Art. R23(5)).

Four things follow from that:

• It is independent. It cannot be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products it assesses, and consultancy services conflict with its independence (Decision No 768/2008/EC, Art. R17(3) and R17(4)).
• It is notified for a law and a procedure. A body “does not need to be qualified to cover all products falling within the scope of that legislation, but may be notified for a defined range of products only” (Blue Guide, section 5.2.3).
• It does not give you the right to the CE marking. “There is no central EU body that gives you permission or a certificate allowing you to use the CE mark” (Your Europe). The manufacturer still declares conformity and affixes the marking (Art. 30(1)Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)Article 30, paragraph 1Click opens the article on EUR-Lex., Art. 30(3)Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)Article 30, paragraph 3Click opens the article on EUR-Lex.).
• It can work for you from outside the EU. Notified bodies “are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the Union” (Blue Guide, section 5.2.2).

Which EU laws make you use a notified body

Each law picks its own procedures from the menu in Decision No 768/2008/EC (Blue Guide, section 5.1.2). The table shows what each of the laws online sellers meet most asks of you. A product under several laws follows each of them.

A law not in the table has its own conformity assessment article. Read it the same way: it either lets you assess the product yourself or names a procedure that involves a notified body.

The four-digit number next to the CE marking names the notified body

Under the general rule, where a notified body took part in the production phase, its identification number follows the CE marking (Decision No 768/2008/EC, Art. R12(3)). The body itself affixes the number, or you do it under the body’s instructions. The Blue Guide puts the rule in one line: “The CE marking must be followed by the identification number of the notified body only if it is involved in the production phase” (section 4.5.1.5). So, under the general rule, the mark tells you this:

• No number: no notified body took part, or an accredited in-house body did, or a notified body examined the design only (module B followed by module C) and not the production.
• A number: a notified body took part in the production phase. Several numbers may follow the marking where several bodies took part.

A mark without a number is not wrong in itself: under the general rule the number is needed only where a notified body took part in the production phase. Some laws say it for themselves, and the Machinery Regulation asks for the number after module B with C too, as set out below. Your Europe words it more broadly: “If a notified body is used, its 4-digit ID number must appear next to the CE marking”.

Find a notified body in NANDO, for your law and your procedure

NANDO is the Commission’s notified body list. It holds the identification number of each body and the tasks for which it is notified (European Commission, Notified bodies).

1. Open NANDO and search by your law or product category (Your Europe: “search by product category or legislation”).
2. Choose a body “authorised to carry out the specific conformity assessment procedure required for your product under EU law” (Your Europe). A body listed for your law may be notified for only part of its products or procedures (Blue Guide, section 5.2.3).
3. Take any body that fits: “Manufacturers are free to choose any notified body that has been legally designated to carry out the conformity assessment procedure” (European Commission, Notified bodies).
4. Check that the notification is live. When a notification is suspended or withdrawn, the Commission keeps its details but moves them to a separate part of the site (Blue Guide, section 5.3.3, as of 2022).

No official source gives a price for a notified body

The CE marking has no fee; the assessment does. “You must bear the costs of the conformity assessment, but affixing the CE marking does not have a fee. The cost depends on the complexity of the product and the applicable assessment procedure” (Your Europe). Neither Your Europe nor the Commission’s notified bodies page gives a price or a time, and none of the laws cited on this page sets a fee scale. For medical devices every notified body must publish a list of its standard fees (Art. 50Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 50Click opens the article on EUR-Lex.).

A certificate does not last for ever. The toy certificate is reviewed at least every five years (Art. 20(4)Directive 2009/48/EC, Toy Safety DirectiveArticle 20, paragraph 4Click opens the article on EUR-Lex.). A protective-equipment certificate is valid for at most five years (Annex V, point 6.1, of Regulation (EU) 2016/425), and a medical-device certificate is valid for the period it indicates, at most five years, and can be extended on a re-assessment (Art. 56(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 56, paragraph 2Click opens the article on EUR-Lex.).

A lab report or a paid “CE certificate” is not a notified-body certificate

Three different papers get called a certificate:

The Commission’s warning is direct: “Some organisations offer “voluntary certificates” that are not valid for CE marking. These are not legally recognised”. Such certificates, it says, may “be issued without product testing”, “be used in areas beyond the body’s legal competence” and “mislead customers and regulators” (Your Europe). What the law asks for is the declaration of conformity from the manufacturer and, where your law brought one in, the notified body’s certificate. What separates the declaration from the certificate is on the declaration of conformity.

A test house outside the EU can still be useful, and it can still be the wrong paper. A notified body is a legal entity established in an EU country and notified by it (Blue Guide, section 5.2.1). A body in a country with a mutual recognition agreement is the exception, and only for the products and sectors that agreement covers: EU authorities “shall accept the test reports and certificates issued by bodies that the foreign party has designated under the MRA” (Blue Guide, section 6.7.2). The 2022 Blue Guide names agreements with Australia, New Zealand, the United States, Japan and Switzerland, and says the bodies designated under them figure in a dedicated part of NANDO (section 9.2.1). It adds Canada, where the CETA Protocol on the mutual acceptance of conformity assessment results replaces the earlier agreement (sections 9.2.1 and 9.2.4). None of the agreements it lists is with China. For a body under no such agreement: “Where conformity assessment is required in regulations, national authorities of EU Member States may refuse to accept attestations of conformity issued under accreditation by non-European accreditation bodies not complying with the EU requirements” (section 6.7.2).

Check a number or a certificate against NANDO in four steps

1. Read the certificate. It should name the body and its number, the manufacturer and the product or type it covers, and its conclusions and conditions of validity (Decision No 768/2008/EC, Annex II, Module B, point 6; Blue Guide, section 5.2.2).
2. Look the number up in NANDO. The Commission publishes the list “for information purposes”, and the number “does not confer rights” (Blue Guide, section 5.3.3). A body you cannot find there gives you no sign that an EU country has notified it.
3. Check that the listing covers your law and the procedure the certificate says it applied, and that it is not withdrawn.
4. Check that the product, the manufacturer and the law on the certificate are the ones in the EU declaration of conformity, which names the body (Annex III, point 7), and that the certificate has not run out.

If a step fails, you do not hold a notified-body certificate for this product. If your law requires one, the procedure is not done. If your law lets you assess the product yourself, nothing is lost: the declaration and the technical documentation are what the law asks for (Your Europe).

Great Britain uses approved bodies, not notified bodies

The UK government says conformity assessment bodies for the Great Britain market “are known as UK Approved Bodies and are accredited by the UK Accreditation Service (UKAS). They can only be used to certify products for UKCA marking.” The EU’s notified bodies “can only be used to certify against EU requirements, which can also be used for the Great Britain market under CE recognition or Fast-Track UKCA”, and they are found in NANDO (UK government, updated 21 August 2026).

If you skip a notified body that your law requires

The CE marking then rests on an assessment the law does not accept. An authority’s first-level check covers “the correct choice of conformity assessment procedures” (Blue Guide, section 7.4). Where it finds the CE marking wrongly affixed, or the declaration or the technical documentation missing, it requires you to end the non-compliance, and if that continues it restricts or prohibits the product or has it recalled or withdrawn (Decision No 768/2008/EC, Art. R34). Each EU country sets the penalties (Art. 30(6)Regulation (EC) No 765/2008, accreditation and market surveillance (CE marking)Article 30, paragraph 6Click opens the article on EUR-Lex.). For a toy, an authority can also require you to have a test performed by a notified body at your own expense where the documentation does not meet the Directive’s rules on content, language and translation (Art. 21(4)Directive 2009/48/EC, Toy Safety DirectiveArticle 21, paragraph 4Click opens the article on EUR-Lex.).