What is a Notified Body and who designates it?

A Notified Body (NB) is a third-party conformity assessment body designated by an EU member state to carry out tasks under a CE-marking directive or regulation. The designation is made by a national Notifying Authority (often a ministry) after accreditation by the national accreditation body (in France COFRAC, in Germany DAkkS, in Italy ACCREDIA), in line with Regulation 765/2008. Once designated, the NB receives a four-digit identifier and is listed in the European Commission's NANDO database. Without this listing, its certificates have no regulatory value.

What is NANDO used for and how do I query it?

NANDO (New Approach Notified and Designated Organisations) is the public database managed by the European Commission that lists every active Notified Body, by directive, by member state, by product type and by NB number. Three entry points are available: search by directive or regulation (to map the available offer), search by NB number or name (to verify the precise scope of a known player), search by product type (to find competent NBs for a product family). Each NB record details the notified scope, the annexes covered, the harmonised standards it can reference and the authorised assessment modules.

How do I verify that a Notified Body actually covers my product?

Verification is done on the NB's NANDO record, by crossing three elements: the regulation or directive applicable to the product, the product class or category to be assessed, and the assessment module planned (B, D, F, H, etc.). An NB may be notified for the MDR without covering certain categories (for example active implantable devices), or notified for the RED without covering article 3.3 cybersecurity. Scope is described by MDR codes (MDA, MDN, MDS), annexes or normative references. Any missing reference invalidates the use of that NB for the product in question.

Why is there a shortage of MDR and IVDR Notified Bodies?

The transition from the legacy medical directives (93/42/EEC and 98/79/EC) to the MDR 2017/745 and IVDR 2017/746 regulations required every NB to be redesignated under the new framework, with reinforced criteria (clinical qualification, governance, unannounced audits). Many historical NBs chose not to seek redesignation, and processing times by Notifying Authorities have been long. The result: a count of designated MDR and IVDR NBs clearly lower than under the legacy directives, with client engagement lead times stretching across several quarters and waiting lists closed at some players.

Does a Mutual Recognition Agreement (MRA) waive the need for a Notified Body?

Not in the general case. The MRAs signed by the European Union with the United States, Canada, Australia, Japan and Switzerland cover limited sectors (typically telecommunications and some aspects of electrical safety) and provide mutual recognition of test reports or certificates, not a waiver of assessment. For the majority of EU regulations (MDR, IVDR, ATEX, lifts, pressure equipment), assessment by a European Notified Body remains necessary to place the product on the Union market, even when parts of the dossier were produced abroad.

Can a Notified Body be changed during or after certification?

Yes, but with conditions. The contract with the initial NB frames the termination terms, and transferring a type certificate to another NB usually involves a fresh documentary review and sometimes additional testing. If an NB's designation is withdrawn (a measure taken by the Notifying Authority), already-issued certificates remain valid during a transitional period, but the manufacturer must identify a successor NB. Voluntary change is heavy: it must be planned contractually and budgeted as three to six additional months.

What is the difference between a Notified Body, a Certification Body and an accredited laboratory?

The three roles are distinct. A Notified Body is designated by a member state to issue European regulatory certificates (CE marking). A Certification Body (CB) under IECEE or ISO 17065 issues voluntary certificates or non-EU certificates (CB Scheme, national quality marks). An ISO 17025 accredited test laboratory carries out measurements and writes test reports, but does not issue a regulatory certificate. A single industrial group may host all three functions under separate entities; it is essential to verify which entity is being contracted for which task.

What contractual pitfalls come up most often when choosing a Notified Body?

Five pitfalls recur. The first is poorly framed scope (any extension is re-billed as a new dossier). The second is the absence of a clause on fee evolution (uncapped annual revision). The third is weak commitment on lead times (no penalty, simple best-effort obligation). The fourth is ownership of subcontracted test reports (the NB may prohibit their reuse by another NB). The fifth is confidentiality of transmitted design data (asymmetric clauses in favour of the NB). A contract review by an experienced procurement function avoids these traps.

Choosing a Notified Body: NANDO and scope verification

Author Hugues Orgitello Last updated 27 May 2026 ~11 min read

Guide · Selecting a European Notified Body

When the chosen assessment route requires a Notified Body, the choice of that body stops being an administrative formality and becomes a technical, commercial and calendar decision. The European Commission's NANDO database, managed by DG GROW, is the only official source listing active Notified Bodies, their precise scope and the perimeter of tasks they are authorised to carry out. This page describes how NANDO works, the scope-verification method, the post-MDR and post-IVDR state of the market, the criteria for choosing an NB, and the contractual pitfalls that surface most often.

What a Notified Body actually is

A Notified Body is a conformity assessment body designated by a member state to carry out tasks under a Union harmonisation act (a CE-marking regulation or directive). The designation rests on two pieces of evidence: accreditation by the national accreditation body in line with ISO/IEC 17065 or equivalent standards, and formal notification by the member state's Notifying Authority, transmitted to the European Commission and the other member states. The common framework is set by Regulation 765/2008 and Decision 768/2008/EC.

Once notification takes effect, the NB receives a unique four-digit identifier (NB number) that must appear next to the CE marking whenever the NB has been involved in the production phase (modules D, E, F, H in particular). The identification number is never reassigned; a disappeared or withdrawn NB keeps its historical number in NANDO with a withdrawal mention.

An NB may be established in any member state of the Union and issue certificates valid across the whole internal market. The choice of a French, German, Italian or Dutch NB has no legal effect on certificate validity; it has significant practical effects on lead time, working language and cost.

NANDO in practice

NANDO is publicly accessible from the DG GROW portal. It is updated continuously and reflects the real state of designations. Three search entries are provided, each answering a different question.

NANDO query workflow

Identify the harmonisation act applicable to the product. A typical IoT product falls under the Directive 2014/53/EU (RED), the Directive 2014/30/EU (EMC) and the Directive 2014/35/EU (LVD). A medical device falls under the Regulation 2017/745 (MDR). Each act carries its own list of NBs.
Access the list of NBs for that act. Under NANDO's Legislation heading, each act displays the list of active NBs with their number, status (active, suspended, withdrawn) and country of notification.
Filter by product or by module. For the MDR, the list filters by codes (MDA, MDN, MDS, MDT, etc.) covering product families and activity types. For the RED, the filter applies to annexes (III, IV) and to article 3.3 cybersecurity where relevant.
Open the detailed NB record. The record shows the legal name, address, notifying authority, detailed scope per act (codes, annexes, harmonised standards) and history of modifications. Not every NB presents its scope at the same level of detail: some list standards precisely, others stay general.
Cross-check with the product's technical scope. For each essential requirement or assessment module planned in the certification plan, verify that an adequate reference appears in the record. A missing scope is a hard exclusion criterion.
Document the verification in the technical file. A dated capture of the NANDO record should be archived together with the NB contract. Scope evolves: the version captured at engagement time is what binds the two parties.

Reading a NANDO record line by line

An NB record under the MDR typically presents several sections: Codes (product categories), Horizontal codes (cross-cutting qualifications: clinical investigations, biocompatibility), Annex (MDR annexes covered: IX, X, XI). For the RED, the record distinguishes annex III (module B), annex IV (module H) and article 3.3 coverage where applicable. Any not covered mention or sheer absence of a line means: excluded from scope, no certificate possible.

State of the market: capacity per regulation

The transition from legacy sectoral directives to the MDR and IVDR regulations, combined with tighter designation criteria, has sharply reduced the count of operational Notified Bodies in the medical sector. The RED, by contrast, enjoys a broader and more mature market.

Regulation	Indicative capacity	Access tension
Regulation 2017/745 (MDR)	Reduced compared with directive 93/42/EEC	High: engagement lead times of several quarters, closed lists at some NBs
Regulation 2017/746 (IVDR)	Even more reduced than MDR	Very high: minority capacity, extended transitional period
Directive 2014/53/EU (RED)	Broad	Moderate: typical lead times of 6 to 16 weeks
Directive 2014/34/EU (ATEX)	Stable	Moderate: sufficient capacity but specialisation by category
Directive 2014/68/EU (PED, pressure equipment)	Stable	Low to moderate
Directive 2014/33/EU (lifts)	Stable	Low

Precise counts are volatile: NANDO reflects active designations that evolve through withdrawals, suspensions and new entries. The recommended practice is to verify NANDO directly at engagement time rather than rely on a published figure.

The structural lesson is steadier: for a medical device under the MDR, contractual engagement with an NB must start well ahead of the market launch milestone (typically twelve to twenty-four months before the targeted release). For a standard RED product, the engagement lead time stays in the order of a quarter, often less.

Scope verification: operational checklist

The notified scope of an NB is the central element of verification. A misread scope leads to a certificate with no legal value when market surveillance or litigation arises. The checklist below should run before contract signature.

Harmonisation act: is the NB notified for the applicable regulation or directive, in the version currently in force?
Assessment module: can the NB conduct the chosen module (B, C2, D, F, H per the plan)? Coverage of an act does not presuppose coverage of every module.
Product family: is the product's technical category listed (MDx codes for the MDR, EX classes for ATEX, type of radio equipment for the RED)?
Specific requirements: for the RED, is article 3.3 (cybersecurity, data protection, fraud prevention) covered? The 1 August 2025 entry into force has reshaped scopes; some lines are still being updated.
Harmonised standards cited: do the standards referenced for the product (for example EN 18031 for radio cybersecurity) appear in the scope?
History: does the record show recent suspensions, withdrawals or amendments? A close sequence of amendments sometimes signals an unstable institutional situation.
Announced capacity: does the NB publish an audit calendar or a lead-time indication? Failing that, ask for a written commitment.
Working language: does the NB accept dossiers and exchanges in the manufacturer's language? Most work in English; a few in French (LCIE Bureau Veritas), German (historical TUV bodies) or Italian (IMQ, Italcert).

See the CE procedure for the sequencing of stages where an NB intervenes, and Self-declaration vs Notified Body for the case where the third-party route can be avoided.

Criteria for choosing a Notified Body

Once scope has been verified as sufficient, several NBs may be eligible. The choice then turns on practical criteria rarely made explicit in commercial materials.

Criterion 1: capacity and lead time

Engagement lead time ranges from one quarter to several years depending on regulation and NB. For a programme with a constrained calendar, this is often the decisive criterion. Ask for:

the availability of the NB project manager over the planned window,
the typical duration between dossier submission and first technical feedback,
the typical duration between non-conformity closure and certificate issuance,
the contractual commitment on these durations (penalties, advance-notified slippage, escalation mechanisms).

Criterion 2: geographic preference and language

A geographically close NB facilitates on-site audits (modules D, E, H), reduces travel costs and accelerates iterations. An NB working in the manufacturer's language removes the cost and risk of translating the technical file. For French manufacturers, LCIE Bureau Veritas (0081) is one of the few NBs that accepts the full procedure in French.

Criterion 3: industrial reputation and acceptance by third markets

A certificate issued by an NB recognised beyond the EU (TUV Rheinland, TUV SUD, DEKRA, Intertek) makes the dossier easier to use in third jurisdictions (Switzerland, the United Kingdom, sometimes the United Arab Emirates, Singapore). For a B2B product sold to demanding integrators, the NB name can be a commercial argument.

Criterion 4: fees and contract clauses

The NB quote covers a documentary review, possibly testing (when the NB is also a laboratory) and the certificate itself. The variables to compare across quotes:

unit price of the documentary review and auditor hourly rate,
regime for scope extensions (lump sum, re-billing, cap),
frequency and cost of surveillance audits (modules D, E, H),
annual fee-evolution rule (index, cap, renegotiation conditions),
intellectual property regime for subcontracted test reports,
confidentiality clauses (symmetry, post-termination duration),
termination conditions and certificate transfer to another NB.

Criterion 5: pre-application meeting

Many NBs offer a free or low-cost pre-application meeting. This meeting is a worthwhile investment: it calibrates scope, identifies risk zones in the technical file and adjusts the calendar. Skipping this stage to gain two weeks often doubles the overall lead time.

Specific risks

Designation withdrawal

The Notifying Authority can withdraw or suspend an NB's designation. Typical triggers: serious failure found in joint audit, bankruptcy, restructuring, non-conformity with the reinforced requirements of the MDR or IVDR. Already-issued certificates remain valid during a defined period (typically a few months to two years depending on the regulation and the decision), but the manufacturer must organise the transfer to another NB.

NANDO publishes each NB's history. A cautious manufacturer reviews this history before signing: an NB suspended a year ago, even if reinstated, carries higher institutional risk.

Disappearance of an NB through merger

The NB market sees regular mergers and restructuring. The four-digit number is attached to a legal entity: if that entity disappears, certificates are generally transferred to the acquiring entity, which obtains its own designation and its own number. The manufacturer must then refresh its documentation to reflect the correct NB number.

Conflict of interest

An NB cannot assess a product it has helped to design. The design-assessment separation is required by ISO/IEC 17065 and by the annexes of the regulations concerned. If a group entity of the NB has provided consulting to the manufacturer, the absence of conflict of interest must be formally documented, or another NB chosen.

Notified Body, Certification Body, accredited laboratory: do not confuse

The vocabulary of certification covers several distinct roles, often handled by different entities within the same industrial group. The confusion is frequent and carries legal consequences.

Role	Mandate	Reference	Identifier
Notified Body (NB)	Regulatory assessment for CE marking	Designation by a member state, NANDO	Four-digit number
Certification Body (CB)	Voluntary certifications (IECEE CB Scheme, quality marks, non-EU schemes)	ISO/IEC 17065 accreditation	National accreditation number
Accredited test laboratory (ATL)	Measurements, tests, technical conformity reports	ISO/IEC 17025 accreditation	National accreditation number
Test house / consortium	Consortium certifications (Bluetooth SIG, Wi-Fi Alliance, USB-IF, DLNA/OCF)	Consortium rules	Consortium identifier
TCB / FCB	FCC or ISED certification (North-American regimes)	FCC or ISED designation	TCB or FCB number

Consortium certifications (for example the Bluetooth SIG qualification or the OPC verification at a cellular operator) are not carried out by Notified Bodies in the European sense. They are contractual, based on the consortium or operator rulebook. A manufacturer may need an NB certificate (CE marking), a consortium qualification (access to the Bluetooth trademark) and an operator certification (network acceptance) simultaneously. These tracks are independent and their calendars must be aligned at programme start.

For neighbouring regimes, see the MDR guide for the medical sector and the glossary for formal definitions.

Mutual recognition: how far MRAs reach

Mutual Recognition Agreements (MRAs) signed by the European Union with third countries are sometimes invoked as a waiver of European assessment. The reality is narrower.

Active MRAs cover a limited number of sectors, mainly telecommunications (radio terminals) and certain parts of electrical safety. They allow:

a laboratory or assessment body in the third country, designated under the MRA, to produce test reports or certificates acceptable in the other party for the targeted sectors,
savings on cost and time for the sectoral testing covered,
coordination between national authorities for market surveillance.

They do not allow:

waiving European NB assessment when the applicable regulation requires an NB,
extending recognition to sectors not covered by the MRA (medical, ATEX, lifts, pressure equipment are excluded from active MRAs),
replacing the CE marking with another marking.

The main active MRAs concern Switzerland (broad coverage, special status linked to EFTA), the United States (telecoms, limited electrical safety), Canada (telecoms, electrical safety), Australia and New Zealand (telecoms), Japan (limited telecoms). Israel and the United Kingdom have separate bilateral arrangements.

The practical lesson: a North-American manufacturer exporting to the EU must, in most cases, involve a European NB for the relevant harmonisation acts, even when part of the testing can be done in the country of origin under an MRA.

Common pitfalls

Scope framing

Verify the scope at signature time, not at quote time. NANDO scope evolves. A record consulted three months earlier may be outdated.
Distinguish the NB's scope from the affiliated laboratory's scope. An NB may rely on an internal or external laboratory for testing; the 17025 accreditation scope of the laboratory is not enough, the NB's notification scope must match.
Do not confuse annex and module. An NB notified for MDR annex VII is not automatically competent for annex IX.

Calendar

Engaging the NB too late. The classic sequencing places the NB contract after technical file finalisation. For the MDR and IVDR, that is too late: queue alone can absorb programme margins. Engage the NB in parallel with design.
Underestimating the pre-application meeting. This meeting is not a commercial formality; it is the first informal audit. Arriving prepared cuts several weeks from the overall lead time.
Ignoring post-certification surveillance. Modules D, E and H impose annual audits. Budgeting them as initial CapEx leads to an accounting surprise one year later.

Contract

Uncapped pricing. The absence of a cap on annual evolution exposes the buyer to sharp increases during capacity-tension periods.
Report portability. A test report subcontracted by the NB can be contractually locked and unusable by another NB. Negotiate portability.
Asymmetric clauses. One-way confidentiality, NB-country jurisdiction, absence of a transfer clause: these points are negotiable in the pre-contract phase, far less so after signature.

Designation

Check the designation history. An NB recently redesignated under a new framework (MDR coming out of a legacy IVD scope) may be technically competent but administratively immature, with significant learning delays.
Anticipate withdrawal. Include in the contract a transfer clause if the NB loses its designation, with an NB commitment to facilitate transfer (delivery of the full dossier to a successor).

Going further

Selecting a Notified Body is rarely isolated: it sits within the assessment procedure defined by the applicable regulation. For the upstream sequencing, see the CE pillar and the CE procedure. For the decision upstream (self-declaration or NB), see Self-declaration vs Notified Body. For specifics of the medical sector (the most NB-capacity-constrained), see the MDR guide. The glossary carries the formal definitions (NB, CAB, NANDO, MRA, accreditation, notification).

Sources & references

NANDO, database of Notified and Designated Bodies , European Commission ec.europa.eu/growth/tools-databases/nando/
Regulation (EC) 765/2008 on accreditation and market surveillance , EUR-Lex eur-lex.europa.eu/eli/reg/2008/765/oj
Decision 768/2008/EC, common framework for the marketing of products (Blue Guide) , EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
Blue Guide on the implementation of EU product rules , European Commission ec.europa.eu/docsroom/documents/49457
Regulation (EU) 2017/745 (MDR), requirements applicable to Notified Bodies, Annex VII , EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
EU Mutual Recognition Agreements (MRAs) , European Commission (DG TRADE) policy.trade.ec.europa.eu/help-exporters-and-importers/accessing-markets/goods-and-services/industrial-goods/mutual-recognition-agreements-mras_en