How to Choose a Notified Body for Medical Devices and IVDs

A practical MDR and IVDR selection guide featuring BSI, TÜV SÜD, DQS and other options

The right Notified Body is the one whose current designation scope, device codes, technical and clinical expertise, capacity, communication model and long-term services fit your device and regulatory strategy. Brand recognition and price matter only after you have confirmed that the organisation is authorised and suitably experienced to assess your product.

For EU medical devices and in vitro diagnostic medical devices (IVDs), the official starting point is the European Commission’s NANDO information system. NANDO shows which bodies are designated under the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), together with the codes and conformity assessment activities within each designation scope.

Quick answer: how should you choose a Notified Body?

1. Confirm that a Notified Body is required for your device class and conformity assessment route.
2. Use NANDO to filter by MDR or IVDR and verify the exact designation scope and applicable codes.
3. Shortlist bodies with demonstrable experience in your device category, technology and evidence strategy.
4. Ask about current capacity, reviewer and auditor availability, application timing and review continuity.
5. Compare the full certification cost, including technical documentation assessment, audits, travel, surveillance, changes and recertification, not only the application fee.
6. Evaluate communication, portfolio fit and the long-term relationship after certification.
7. Approach candidates early, but submit only when the technical documentation and QMS are genuinely review-ready.

What is a Notified Body for medical devices?

A Notified Body is an independent conformity assessment organisation designated by a national authority to perform specific tasks under EU product legislation. When third-party assessment is required, the Notified Body reviews the manufacturer’s quality management system and/or technical documentation within its designated scope. A positive assessment supports the certificates needed for the manufacturer to draw up the EU declaration of conformity and affix the CE mark, subject to the applicable route.

Do not confuse a Notified Body with a competent authority. The competent authority is a government regulator responsible for enforcement, market surveillance, vigilance and oversight. The Notified Body is the designated third party that carries out defined conformity assessment activities.

Notified Body or competent authority: which one do you need?

Manufacturers may need to interact with both, but for different reasons. Use the purpose of the interaction as the first decision point.

If you need to…	You will usually deal with…	Why
Complete third-party conformity assessment for CE marking when MDR or IVDR requires it	A Notified Body	It assesses defined elements of the QMS and technical documentation within its designation scope.
Obtain authorisation for a clinical investigation or performance study where national approval is required	A competent authority, and often an ethics committee	The authority performs the national regulatory review for the study. The exact pathway depends on the country and study.
Report serious incidents, respond to market-surveillance action or manage regulatory enforcement	A competent authority; for a certified device, the relevant Notified Body may also be informed or involved	The competent authority leads vigilance, market surveillance, and enforcement. Where a Notified Body issued the device certificate, it receives relevant vigilance information and is notified of certain regulatory measures; it may then assess the effect on certification.
Confirm whether a conformity assessment body is designated and overseen	The competent authority designates and oversees the Notified Body; consult NANDO to verify the designation and scope	Designation and oversight are performed by public authorities. NANDO publishes the Notified Body’s designation and scope, while the Notified Body performs conformity assessment.

When do you need a Notified Body under MDR or IVDR?

The need for Notified Body involvement depends on the applicable regulation, device class, device characteristics and conformity assessment route. The following is a high-level orientation; classification and route should be confirmed for the specific product.

Regulation	Usually requires a Notified Body	Lowest-risk exception
EU MDR	Class IIa, IIb and III devices. Class I sterile (Is), measuring (Im) and reusable surgical instruments (Ir) require limited Notified Body involvement for the relevant aspects.	Class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments can generally be self-declared.
EU IVDR	Class B, C and D IVDs. Class A sterile IVDs require limited Notified Body involvement for sterility-related aspects.	Class A non-sterile IVDs can generally be self-declared.

Regulatory source: Norwegian Medical Products Agency: conformity assessment involving a Notified Body

How to find eligible Notified Bodies in NANDO

NANDO is the European Commission’s source of truth for designated Notified Bodies. A company’s website, reputation or four-digit Notified Body number does not prove that it covers your specific device. Designation is regulation-specific and code-specific.

1. Select the correct legislation. Filter separately for Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). An MDR designation does not confer an IVDR designation.
2. Open the body’s notification. Confirm the legal entity, country and Notified Body identification number. Large certification groups may operate through different legal entities in the EU and the UK.
3. Match every relevant code. Review codes related to the medical device or IVD type, intended purpose, specific characteristics and technologies, plus technical competencies.
4. Confirm the procedure. Check that the body is designated for the required conformity assessment activities and annexes, not merely a related product category.
5. Record the verification date. Designation scopes can change. Capture the NANDO evidence in the selection file and recheck it before the formal application.

Official resource: European Commission: Notified bodies for medical devices and NANDO links

How to choose a Notified Body: the criteria that matter

1. Designation scope and codes

This is the non-negotiable gate. If NANDO does not show the required regulation, codes and conformity assessment activities, remove the notified body from the shortlist. Do this before comparing timelines, location or price.

2. Experience with your device and technology

Two bodies may hold similar codes but have very different practical experience. Ask about comparable medical devices or IVDs, the technologies involved and the typical deficiencies their teams encounter. For software and AI-enabled devices, explore software lifecycle, cybersecurity and AI/ML competence. For IVDs, ask about the relevant scientific and performance-evaluation domain.

3. Clinical or performance evidence fit

All Notified Bodies apply the same legal framework, but review approaches and evidence expectations can differ. According to MDx CRO’s medical device and IVD experts, manufacturers should look beyond the organisation’s name and assess whether its clinical reviewers understand the technology, intended purpose, target population and planned evidence strategy.

“I would not choose an NB looking for a more permissive clinical interpretation. I would ask who will assess this type of clinical evidence and how much experience they have with this type of device.”

Catarina Sepúlveda | IVD Director at MDx CRO

4. Capacity and realistic availability

Capacity is a strategic selection factor. Ask whether the body is accepting new applications, when the application can be reviewed, when auditors and technical reviewers are likely to be assigned and how the proposed timeline will be maintained. A technically suitable body without capacity may not support the market-access plan.

5. Communication and review continuity

Responsiveness during sales is not enough. Ask how questions are consolidated, how changes in reviewer availability are communicated and whether the same reviewers usually remain involved throughout the assessment. Continuity can reduce repetition and improve efficiency.

6. Total cost, not the headline fee

Standard fee lists are public (see European Commission list of Notified Bodies’ standard fees), but quotations are not directly comparable unless they cover the same scope. Model the total cost of QMS audits, technical documentation assessment, clinical or performance review, travel, unannounced audits, external consultations, surveillance, significant changes, additional review cycles and recertification.

7. Portfolio and lifecycle fit

Certification is an ongoing relationship. Manufacturers with several devices, product families or a development pipeline should discuss grouping, sampling, sequencing, surveillance, change review and future submissions before committing.

8. Geography and language

Location can affect travel expense, auditor availability, accepted documentation languages, time zones and access to local support. It is relevant, but generally secondary to scope, expertise, capacity and communication.

Comparing BSI, TÜV SÜD, DQS and other options

BSI, TÜV SÜD and DQS are examples frequently considered by manufacturers, but they should not be treated as interchangeable. The decisive comparison is between the specific EU legal entities and their current NANDO notifications, not brand names alone.

Example	EU entity / NB number	What the current evidence illustrates	What to verify before applying
BSI	BSI Group The Netherlands B.V. / NB 2797	Official NANDO documentation and BSI fee publications are available for medical-device and IVD conformity assessment activities.	MDR or IVDR notification; every relevant code and procedure; current capacity; reviewer fit; full quotation.
TÜV SÜD	TÜV SÜD Product Service GmbH / NB 0123	The organisation publishes regulatory service information and standard fees; the selected service must still be matched to the current NANDO scope.	Exact MDR or IVDR scope and codes; accepted languages; assignment model; timing; change and surveillance costs.
DQS	DQS Medizinprodukte GmbH / NB 0297	The current NANDO notification located for this draft is under the MDR, and the 2026 DQS price list describes MDR conformity assessment services.	Do not infer IVDR eligibility from the brand. Verify the applicable regulation, codes and procedures in NANDO; assess experience, capacity and portfolio fit.
Other bodies	Filter the current NANDO list	A less recognisable body may be a strong fit when its designation, expertise, capacity and service model align with the device.	Use the same evidence-based shortlist and due-diligence questions. Do not lower the scope or expertise threshold.

Is there a “best” Notified Body for medical devices?

No universal best Notified Body exists. The appropriate choice depends on the device or IVD, technology, risk class, applicable codes, evidence package, manufacturer maturity, portfolio, commercial priorities and target timeline. A large, well-known body may offer broad resources but also serve a substantial client base. A smaller body may provide a closer working model but can face narrower scope or staffing constraints. Neither size is inherently better.

The best choice is therefore the best documented fit. Use a scored shortlist, but make scope a pass/fail criterion rather than a weighted preference. A high score for price or communication cannot compensate for missing designation coverage.

How to compare Notified Body fees correctly

Notified Bodies must make their standard fee lists publicly available under MDR Article 50 and IVDR Article 46. The European Commission maintains links to these published lists. However, the fee schedule is an input, not the final cost of certification.

1. Ask each candidate to quote the same device portfolio, sites, conformity assessment route and expected documentation package.
2. Separate application and administration fees from QMS audit, technical documentation, clinical/performance assessment and certification-decision fees.
3. Include travel, external experts or laboratories, authority consultations and unannounced audits where applicable.
4. Model surveillance, changes, certificate maintenance, additional products and recertification across the expected relationship.
5. Clarify whether hourly or daily rates include preparation, reporting and project management.
6. Ask what triggers additional fees and how incomplete or inconsistent submissions affect assessment effort.

Price should rarely be the primary deciding factor. A low initial quotation can become expensive when limited technical fit, a poor submission or repeated evidence gaps lead to additional review cycles. Conversely, a higher headline rate does not prove that the overall project will be faster or better. Compare the scope and assumptions behind the quotation.

Official fee directory: European Commission list of Notified Bodies’ standard fees

Questions to ask a Notified Body before applying

1. Are you currently designated for every relevant MDR or IVDR code and conformity assessment activity for this device?
2. How much recent experience does your team have with comparable devices, technologies, intended purposes and evidence strategies?
3. Are you accepting new applications, and what are the realistic dates for application review, audit, technical documentation review and certification decision?
4. How are technical and clinical reviewers assigned, and how do you maintain review continuity if team members change?
5. How are questions consolidated, communicated and closed? What does a typical review cycle look like?
6. Which recurring deficiencies do you see in recent submissions for this device category?
7. What documentation structure, file format, language and submission portal requirements apply?
8. How should several devices or product families be grouped, sampled and sequenced?
9. What does the quotation include, what is excluded and what circumstances create additional fees?
10. How will surveillance audits, significant changes, PMCF/PMPF updates, new devices and recertification be handled?
11. What information do you need from us to provide a reliable quotation and timeline?
12. If our planned device or evidence strategy is outside your practical experience or current capacity, can you tell us before formal application?

“‘What could make our project stop?’ Ask what normally triggers clock-stops, additional expert review, additional sampling, repeated clinical review or re-quotation.”

Catarina Sepúlveda | IVD Director at MDx CRO

These discussions must respect the Notified Body’s independence. Manufacturers may clarify administrative requirements, scope, submission organisation and process, but should not ask the Notified Body to design their regulatory strategy or provide product-specific consultancy.

What to include in the first enquiry

A specific enquiry produces a more useful response than a generic request for availability. According to MDx CRO’s medical device and IVD experts, the first contact should include:

1. A concise medical device or IVD description and intended purpose.
2. Classification and classification rationale.
3. The proposed MDR or IVDR conformity assessment route.
4. Applicable device, technology and horizontal competency codes.
5. Current QMS status and relevant certifications.
6. Number of devices, variants, product families and manufacturing sites.
7. Development stage and technical documentation readiness.
8. Clinical or performance evidence strategy and known gaps at a high level.
9. Target dates for application, review and CE marking or recertification.

Manufacturers can compare and obtain information from several candidates during the selection stage. Once moving into formal conformity assessment, they should follow the application declarations and exclusivity requirements under the applicable process. The Norwegian Medical Products Agency summarises that a manufacturer cannot apply for conformity assessment of the same device with several Notified Bodies at the same time.

MDR versus IVDR and novel technology considerations

The selection logic is similar under MDR and IVDR, but the available pool, codes and technical expertise differ. An MDR Notified Body is not automatically an IVDR Notified Body. For IVD manufacturers, scientific and performance-evaluation competence may be decisive, particularly for Class C and D IVDs and companion diagnostics.

What IVD manufacturers should investigate

1. Experience with the specific technology, such as molecular diagnostics, immunoassays, genetic testing, companion diagnostics or point-of-care testing.
2. Experience reviewing performance evaluation reports with a comparable intended purpose and claims.
3. Approach to the three performance-evaluation pillars: scientific validity, analytical performance and clinical performance.
4. Experience with multi-site studies, studies conducted outside the EU and specimen representativeness.
5. Common deficiencies the reviewers see in the relevant IVD category.

Code coverage does not, by itself, demonstrate practical experience with the evidence package. Catarina Sepúlveda recommends asking whether the proposed reviewers have assessed the same type of IVD and the same type of evidence, including prospective or retrospective clinical performance studies and the use of leftover specimens, biobanks or external datasets. Where relevant, manufacturers should also verify experience with algorithm-based IVDs, companion diagnostics, Class D procedures and EU Reference Laboratory interaction, and ask how reviewers expect scientific validity, analytical performance and clinical performance to be connected in the performance evaluation report.

Software, AI-enabled and novel medical devices

For software, AI-enabled or otherwise novel devices, verify access to reviewers with the relevant software lifecycle, cybersecurity, usability, clinical and AI/ML competence. The NANDO designation is essential, but it does not by itself reveal the depth of hands-on experience with a particular technology or evidence package.

If your shortlist includes software or AI-enabled devices, MDx CRO’s Software, Digital Health and AI team can help you assess the regulatory, software, cybersecurity and evidence capabilities that the selected Notified Body will need to evaluate.

Submission readiness can matter as much as Notified Body selection

Even a well-matched Notified Body cannot compensate for an unstable product definition or fragmented evidence package. The clearest signs that a manufacturer is not ready include an unsettled intended purpose, classification, conformity assessment route or key claims; an immature QMS without objective implementation records; incomplete required testing; insufficient clinical or performance evidence; and contradictions across the technical file.

“The best submissions are the easiest to review, and not the largest.”

André Moreira & Joana Martins | MDx CRO medical device and IVD experts

Reviewers should be able to trace each claim to clinical or performance evidence, risk controls, verification and validation, applicable requirements and labelling without searching through poorly organised appendices.

A practical pre-submission readiness check

1. The intended purpose, classification, route and claims are stable and justified.
2. The QMS is effectively implemented and supported by records, not only procedures.
3. Required safety, performance, usability, biocompatibility, electrical, software or other testing is complete and report-ready, as applicable.
4. Clinical or performance evidence is device-specific and supports the intended purpose, target population, safety, performance, benefit and claims.
5. Evidence gaps are explicit and linked to an appropriate PMCF or PMPF strategy.
6. Risk management, verification and validation, clinical/performance evidence, labelling, PMS and PMCF/PMPF tell the same story.
7. Every cross-reference resolves to a controlled, current document and responses can point reviewers to exact evidence.

“A Notified Body review should confirm compliance, not identify fundamental gaps in the technical documentation.”

André Moreira & Joana Martins | MDx CRO medical device and IVD experts

An independent gap assessment or mock review can identify fundamental gaps before they consume formal review time.

Manufacturers who want to test readiness before formal review can use MDx CRO’s regulatory affairs and technical documentation support to identify and resolve cross-document gaps. For IVD programmes, the IVDR pre-submission assessment provides a focused review of technical documentation structure, consistency and evidence readiness.

Common mistakes when selecting a Notified Body

1. Choosing by brand alone. A recognised name does not prove current scope, code coverage, available capacity or device-specific expertise.
2. Treating selection as a procurement exercise. Price and availability are important, but they cannot replace technical fit and long-term lifecycle planning.
3. Checking the regulation but not the codes. An MDR or IVDR designation can still exclude the codes or procedures your device requires.
4. Waiting until the technical file is complete to make contact. Late engagement limits options and may expose an unrealistic CE-marking plan.
5. Submitting before the file is ready. Early contact is valuable; early formal submission of inconsistent documentation is not.
6. Ignoring the product pipeline. A body that fits one device may not cover the future portfolio or the technologies planned next.
7. Comparing quotations on headline price. Different assumptions about audits, review days, travel, surveillance and changes can make apparent price comparisons misleading.
8. Failing to investigate review continuity. Frequent team changes can lead to repeated explanations and inefficient cycles.

When should manufacturers contact Notified Bodies?

Start earlier than the formal submission. Potential Notified Bodies can be contacted while the regulatory strategy, development plan, and conformity assessment route are being finalised, and when the technical file is approximately 50% ready, specifically the device description. Early engagement helps confirm designation scope, applicable codes, relevant experience, capacity, application requirements, costs, timelines, and planning assumptions.

For recertification, André Moreira and Joana Martins suggest that beginning planning approximately 12 to 18 months before certificate expiry may help reduce the risk of a certification gap, although the appropriate lead time depends on the device, assessment complexity and Notified Body capacity. This is a planning guideline, not a regulatory deadline.

Early contact should not be confused with an early submission. Enter formal review only when the technical documentation is sufficiently mature and the QMS can demonstrate effective implementation.

What changes under Commission Implementing Regulation (EU) 2026/977?

Commission Implementing Regulation (EU) 2026/977 introduces more uniform procedural requirements for MDR and IVDR conformity assessment. It applies from 25 February 2027, subject to its transitional provisions; Article 4(4) applies later, from 1 January 2028.

For manufacturers comparing Notified Bodies, the regulation is particularly relevant because quotations must include estimated overall costs, potential extra costs and estimated timelines. A Notified Body must inform the manufacturer in advance and explain an increase above 10% of the estimated costs. The regulation also sets maximum timelines for defined assessment phases, with permitted interruptions when the manufacturer must address non-compliances or justified requests.

These procedural limits should improve predictability, but they do not make submission quality irrelevant. Incomplete applications, inconsistent files and weak responses can still stop the clock, create remediation work and delay market access.

Primary source: Commission Implementing Regulation (EU) 2026/977 on EUR-Lex

What happens after you choose a Notified Body?

1. Application and completeness review: the body confirms that the application is complete and within scope.
2. Quotation and written agreement: scope, assumptions, costs, timelines and contractual terms are agreed.
3. QMS and technical documentation assessment: activities depend on the regulation, class and conformity assessment route.
4. Questions and non-conformities: the manufacturer responds with complete, evidence-based answers and controlled document updates.
5. Final review and certification decision: certificates are issued only after the relevant assessment activities are successfully completed.
6. Surveillance and lifecycle work: audits, technical documentation sampling, PMS, PMCF/PMPF, significant changes, portfolio additions and recertification continue after initial certification.

How to avoid repeat deficiencies during the assessment

Once the review is underway, a response should do more than address the wording of the Notified Body’s question. The manufacturer should correct the underlying controlled document, assess the impact across the rest of the technical documentation and make sure the response remains consistent with the device, claims and evidence package.

“One good rule is: answer the question, fix the file, and check whether the same issue exists elsewhere in the technical documentation. Otherwise the manufacturer solves deficiency X only to receive essentially the same issue again in deficiency X+1.”

Catarina Sepúlveda | IVD Director at MDx CRO

How MDx CRO supports Notified Body readiness

MDx CRO supports medical device and IVD manufacturers with the work that makes a Notified Body submission assessable and defensible. The objective is not to promise access to a particular Notified Body or influence its independent decision. It is to help the manufacturer select an appropriate route, prepare consistent evidence and manage the submission effectively.

1. Regulatory strategy, classification and conformity assessment route assessment.
2. MDR and IVDR code mapping for a focused Notified Body search.
3. Technical documentation gap assessments, remediation and authoring.
4. Clinical evaluation and IVDR performance-evaluation strategy.
5. QMS, risk management and traceability reviews.
6. Mock Notified Body reviews and submission-readiness assessments.
7. Deficiency-response planning and controlled cross-document updates.

If you are preparing an MDR or IVDR submission, MDx CRO’s regulatory affairs and technical documentation team can help you assess readiness, organise remediation and prepare a consistent evidence package. Discuss the submission with our team.

Frequently asked questions