How many EU MDR notified bodies are there in 2026?

As of mid-2026, approximately 45–50 notified bodies are fully designated under EU MDR 2017/745, compared to over 80 that were designated under the old Medical Device Directive (MDD). This reduction has created capacity constraints and longer certification timelines at many NBs. The complete and authoritative list is maintained in the European Commission’s NANDO database, updated in real time as designations are granted, extended, or withdrawn.

How long does EU MDR notified body certification take?

For Class IIb and Class III devices in 2026, expect 12–30 months from initial NB contact to certificate issuance. Class IIa devices typically take 9–18 months. The timeline varies by NB queue length, device type, and technical documentation quality. The Class III scrutiny procedure with the relevant Expert Panel adds an additional 30–90 days. Starting the process before your MDD certificate expires is essential.

What happens to medical device tenders if my EU MDR certificate expires?

An expired or missing EU MDR certificate typically results in automatic disqualification from EU hospital tenders. Since 2023–2024, most EU hospital procurement authorities — particularly in Germany, the Netherlands, France, and the Nordic countries — treat valid MDR certification as a pass/fail criterion. If your NB certificate lapses during an active tender period, you may be unable to respond to or fulfil framework contract obligations until renewal is complete.

Can I change notified bodies after initial MDR certification?

Yes, manufacturers can transfer NB certificates to a different notified body, but the new NB must conduct its own full assessment of your technical documentation. This typically takes 6–12 months. The old certificate remains valid during the transfer period if renewal is managed correctly. Most regulatory teams prefer to maintain relationships with their original NB where possible to avoid transition complexity and delay.

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KonformitätRegulierung

EU MDR Notified Bodies: Complete List and How to Choose the Right One (2026 Guide)

18. Mai 2026

If you sell medical devices in Europe, your EU MDR notified body (NB) is one of the most consequential partners you will choose. The right NB accelerates your MDR certification, keeps your products competitive in hospital tenders, and ensures you meet the increasingly strict documentation requirements that European procurement authorities now enforce as a pass/fail gate.

This guide covers: what EU MDR notified bodies do, the current list of designated NBs, how to choose the right one for your device class and timeline, and — critically — how your NB choice directly affects your success in European hospital tenders.

What is an EU MDR notified body?

A notified body is a third-party conformity assessment organisation designated by an EU member state authority (the “designating authority”) to assess whether a medical device meets the requirements of EU MDR 2017/745. Once assessed and approved, the NB issues a CE certificate that allows the device to be placed on the EU market.

Not all device classes require NB involvement:

Class I devices: Self-declaration by manufacturer (no NB required, except for sterile, measuring, or reusable surgical instruments)
Class IIa devices: NB assessment of technical documentation or quality management system
Class IIb devices: NB assessment of technical documentation and QMS, including design examination for certain devices
Class III devices: Full NB assessment including EU technical documentation review, with mandatory scrutiny by the relevant Expert Panel for implantable devices

Under MDR (compared to the old MDD), the assessment scope has expanded significantly. MDR requires more clinical evidence, post-market clinical follow-up (PMCF), SSCP (Summary of Safety and Clinical Performance) for Class III and implantable devices, and more rigorous economic operator documentation. This means more work for NBs — and, in turn, longer assessment timelines across the board.

The current EU MDR notified body landscape

The number of MDR-designated notified bodies is substantially lower than the number that existed under MDD. As of 2026, approximately 45–50 notified bodies are fully designated under EU MDR 2017/745, compared to over 80 under MDD. This represents a significant capacity constraint that created multi-year delays between 2021 and 2024 and continues to affect timelines today.

The authoritative list is maintained in the European Commission’s NANDO (New Approach Notified and Designated Organisations) database. Always verify current designation status and scope directly in NANDO before making a selection, as designations change throughout the year.

Major EU MDR-designated notified bodies (2026)

Notified Body	NB Number	Country	Key Strengths
TÜV SÜD Product Service GmbH	0123	Germany	All device classes; very large capacity; broad NANDO scope
TÜV Rheinland LGA Products GmbH	0197	Germany	IVD, implantables; strong in active devices and software
BSI Group The Netherlands B.V.	2797	Netherlands	Global presence; software/digital health; wide device types
SGS Fimko Oy	0598	Finland	Active devices, IVD; good for SMEs; responsive intake
Kiwa Notox B.V.	0344	Netherlands	Class IIa/IIb; diagnostics; strong EU procurement familiarity
DEKRA Testing and Certification GmbH	0124	Germany	Electrical/electronic devices; software as medical device
GMED S.A.S. (Bureau Veritas group)	0459	France	Broad scope; strong for French and Southern EU markets
MEDCERT GmbH	0482	Germany	Active implantable devices; Class III specialist
DQS Medizinprodukte GmbH	0297	Germany	QMS audits; combination products
Eurofins Product Testing A/S	0543	Denmark	Sterile devices; biological evaluation; Nordic market expertise

NB designation status and scope are subject to change. Always verify against the NANDO database before initiating contact with any notified body.

How to choose the right EU MDR notified body

Choosing a notified body is not just a compliance exercise — it is a strategic decision that affects your CE certification timeline, audit costs, and, ultimately, your competitiveness in European hospital tenders. Five factors should drive your selection:

1. Scope coverage for your device class and type

Each NB has a specific scope of designation defined by device class, Annex and Rule references, and GMDN codes. Before shortlisting NBs, confirm that their NANDO scope covers your specific device classification under MDR’s classification rules. A common and costly mistake is selecting an NB based on name recognition alone, then discovering their scope does not include your Annex VIII classification rule or your specific intended use.

2. Capacity and realistic timeline

This is the most pressing constraint in 2026. The reduction in MDR-designated NBs created a bottleneck that has eased somewhat but still produces 6–18 month queue times at the busiest NBs. Ask each NB directly: “What is your current queue for a new application for a Class [X] device with our intended use and clinical profile?” Honest answers will vary by 12+ months across NBs of similar reputation. Plan your timelines based on actual queue data, not NB marketing materials.

3. Technical expertise in your device type

Expertise varies significantly across device categories. An NB with deep specialisation in active implantable cardiovascular devices may have limited experience with IVD reagents, and vice versa. Ask for references from manufacturers with similar device types. Request clarity on how their reviewers approach clinical evaluation for your specific application. The quality of NB feedback during assessment directly shapes the quality of your technical documentation — good NB reviewers make you better, not just approved.

4. Geographic presence and language

While EU MDR is harmonised regulation, audits and assessments are more efficient when your NB has auditors in your region who understand your language and market. An NB with German auditors is more practical for a German manufacturer than one headquartered in Finland. For global manufacturers, NBs with international audit teams (BSI, TÜV SÜD, DEKRA) often provide more flexible audit scheduling and multilingual assessment support.

5. Cost structure and contractual transparency

NB costs for Class III devices typically run €50,000–€150,000 for initial certification, with annual surveillance costs of €10,000–€40,000 thereafter. Obtain itemised quotes from at least three NBs for your specific device. Pricing transparency varies considerably: some NBs provide detailed fee schedules upfront, others quote only after reviewing a device description. Be cautious of NBs with unusually low initial quotes — they may not be scoping the full assessment, leading to costly supplementary review fees during the process.

The NB assessment process under EU MDR

For a Class IIb or Class III device, expect the following steps from first contact to certificate issuance:

Months 1–2: Pre-submission meeting — Discuss device classification, intended scope, documentation requirements, and initial feasibility. Most NBs offer this at no charge or a nominal fee. Use it to assess NB expertise and responsiveness before committing.
Months 2–4: Application and completeness check — Formal application submission, fee payment, and NB completeness review. The NB confirms your documentation is sufficiently complete to begin substantive assessment — not that it meets MDR requirements. Deficiencies found here delay the clock.
Months 4–18: Technical documentation review — The NB reviews clinical evaluation, risk management (ISO 14971), performance testing, manufacturing documentation, and post-market surveillance plan. Multiple review rounds with queries and responses are the norm under MDR.
Certificate issuance — Once all NB queries are resolved, the certificate is issued. For Class III devices, the mandatory Expert Panel scrutiny procedure adds 30–90 days to this step.

Total timeline: 12–30 months for Class IIb/III devices in 2026, depending on NB queue, device complexity, and technical documentation quality at submission.

Why your notified body choice affects EU hospital tender success

This connection is underappreciated by many regulatory and commercial teams. Your NB affects tender performance in three concrete ways:

Certificate validity during framework contracts

EU hospital procurement now treats valid MDR certification as a pass/fail gate, not a scored criterion. If your certificate expires during the term of a multi-year framework contract, you may be disqualified from contract renewals or extension periods — even if you are the incumbent supplier. Choose an NB that can reliably execute annual surveillance audits and certificate renewals on schedule, with sufficient capacity not to cause delays.

EUDAMED registration alignment

Your NB’s certificate must be correctly linked to your EUDAMED actor and device registrations. Mismatches between your EUDAMED records and your NB certificate — for example, a product registered under a different device classification than what the NB assessed, or a certificate with an NB number that doesn’t match the NANDO registration — are a common source of tender disqualifications in Germany, the Netherlands, and France, where procurement authorities now routinely cross-reference EUDAMED data during technical evaluation.

NB recognition in complex procurement

While EU MDR does not formally rank notified bodies, some hospital procurement authorities — particularly in Eastern European markets and in complex multi-country framework agreements — give informal additional confidence to certificates from large, widely recognised NBs such as TÜV SÜD, BSI, and TÜV Rheinland. For most standard tenders, the NB identity is less important than certificate validity and correct EUDAMED linkage.

For a detailed breakdown of how specific MDR documentation requirements map to what hospitals ask for in tender specifications, see our guide on EU MDR tender requirements for 2026.

Managing NB certificates across an active tender portfolio

Most medical device companies maintain certificates across multiple NBs — from historical legacy decisions or because different NBs cover different product lines. This creates a compliance management challenge: tracking which certificate covers which product, which market, which intended use, and when renewal is due.

Manual tracking in spreadsheets introduces a clear failure mode: an expired or incorrect NB certificate gets submitted in a tender response. This is one of the most common technical rejection reasons in EU hospital procurement. A single outdated certificate submitted to a major hospital framework tender can result in disqualification from a multi-year, multi-million-euro contract.

Purpose-built platforms like MedStrato maintain a live regulatory certificate database and automatically flag any tender submission where the matched NB certificate is expired, within 90 days of expiry, or does not cover the intended use stated in the tender requirement. This eliminates the compliance risk that exists whenever certificate tracking is managed manually across a large product portfolio.

Ready to automate EU MDR compliance tracking for your tender submissions? Book a demo to see how MedStrato handles certificate verification across your full product catalogue, or explore the full feature set.