How to choose your EU Notified Body in 2026

Choosing the right Notified Body is one of the most consequential decisions you will make in your EU medical device registration journey. Get it right, and you have a knowledgeable partner who guides your Technical Documentation through a rigorous but manageable review process. Get it wrong, and you could face months of delays, scope mismatches, or worse — finding out mid-process that your NB is not authorized to certify your device type.

In 2026, the landscape is more complex than it was under the MDD. The transition to EU MDR 2017/745 triggered a complete re-designation process for all Notified Bodies in Europe. Not every MDD Notified Body received MDR designation. Those that did often received it for a limited scope — meaning they may be authorized to review some device types but not others.

Add to this the significant backlog that has built up as manufacturers rush to transition their MDD certifications before the deadlines expire, and you have a market where Notified Body capacity is stretched, wait times are long, and strategic choice matters more than ever.

This article gives you a practical, step-by-step framework for selecting the right Notified Body for your device in 2026.

Step 1 — Confirm Your Device Class and Conformity Assessment Route

Before you approach a single Notified Body, you need to know exactly what kind of review you require. Not all devices need a Notified Body at all — Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments can self-declare conformity without NB involvement.

For devices that do require a Notified Body, the conformity assessment route determines what the NB will review and how deeply.

Class IIa devices can use Annex IX (QMS audit) or Annex XI (product verification). Class IIb devices require Annex IX plus Annex X (type examination) or Annex XI. Class III devices require a full Annex IX QMS review plus Annex X product scrutiny — the most rigorous pathway.

Knowing your route before you approach an NB means you can ask the right questions, compare the right capabilities, and avoid wasting time with bodies that are not designated for your specific pathway.

Step 2 — Check the NANDO Database

NANDO — the New Approach Notified and Designated Organisations database — is the official European Commission tool for finding MDR-designated Notified Bodies. It is publicly accessible at ec.europa.eu and is updated regularly as designations are granted, modified, or withdrawn.

When searching NANDO, filter specifically for Regulation (EU) 2017/745 — not the old MDD directive. This is critical. Some NBs appear in NANDO for MDD but have not yet received MDR designation, or have received it only for a limited scope.

For each NB you identify, check three things. First, confirm they are designated under MDR 2017/745, not just MDD 93/42/EEC. Second, review their scope of designation — this tells you which device types, classification rules, and conformity assessment annexes they are authorized for. Third, check whether their designation is current and not suspended or under review.

Step 3 — Match the NB to Your Device Type and Specialization

MDR designation scope varies significantly between Notified Bodies. Some have a broad designation covering most device types across all classes. Others specialize in specific areas — cardiovascular implants, active devices, in vitro diagnostics, software as a medical device, or combination products.

Choosing an NB with genuine experience in your device category matters for two reasons. First, reviewers who are familiar with your device type will ask better, more focused questions, which typically leads to a more efficient review. Second, specialized NBs are more likely to have relevant clinical expertise available for the clinical evaluation consultation procedures required for certain Class III and implantable devices.

When evaluating fit, ask each NB directly what proportion of their portfolio covers your device type, and whether they have in-house or panel expertise in the relevant clinical specialty.

Step 4 — Assess Capacity and Current Wait Times

In 2025, capacity is one of the most practical constraints in the Notified Body market. The combination of MDR transition pressure, a reduced number of designated NBs compared to MDD, and increasing submission volumes has created significant backlogs at several major bodies.

Before committing to an NB, ask directly about their current wait times for the following milestones — initial application review, contract signing, formal submission acceptance, and anticipated certification timeline. Compare these across at least three NBs before making a decision.

Be cautious of NBs that cannot give you a clear timeline or that are currently not accepting new applications. This is more common than you might expect in 2025, particularly for Class IIb and III devices.

Also ask whether they offer a pre-submission consultation or gap assessment service. Many NBs will review a summary of your Technical Documentation before formal submission and provide feedback on readiness. This can save significant time and reduce the risk of major queries during formal review.

Step 5 — Evaluate Geographical Presence and Language

While EU MDR applies uniformly across all Member States, the practical experience of working with a Notified Body can vary depending on their location, language capabilities, and how they handle communication.

If your manufacturing operations, regulatory team, or key technical contacts are based in a specific country, working with an NB that has offices or reviewers in that region can simplify logistics — particularly for unannounced audits and on-site assessments.

Language is a practical consideration for smaller teams. If your regulatory documentation is primarily in English, confirm that the NB's review team is fully proficient in English. Most major NBs operate in English as a default, but it is worth confirming for technical review and audit teams specifically.

Step 6 — Compare Fees and Contract Terms

Notified Body fees are not publicly listed, and they vary considerably depending on device class, conformity assessment route, number of products covered, and the NB's own pricing structure. Expect to invest significantly for a full MDR certification — initial certification fees for a Class III device at a major NB can range from €15,000 to €50,000 or more, with annual surveillance fees on top.

When comparing quotes, make sure you are comparing the same scope. Ask each NB to provide a detailed breakdown covering application fee, contract fee, technical file review, QMS audit, and annual surveillance. Hidden costs — such as fees for responding to queries, additional sampling, or unannounced audit travel expenses — can add up quickly.

Also review contract terms carefully. Key items to check include what happens if the NB's designation scope changes during your review, how disputes are handled, and what the process is for transferring to another NB if needed.

Step 7 — Request References and Evaluate Communication

Before signing a contract, ask the NB for references from manufacturers in a similar device category. A reputable NB will be comfortable providing this. Speaking directly with other manufacturers about their experience — review quality, communication responsiveness, query handling, and audit conduct — gives you insight that no brochure or sales pitch can provide.

Pay attention to how the NB communicates with you during the pre-contract phase. Are they responsive? Do they give clear, specific answers? Do they assign you a dedicated contact? The quality of communication before you sign is a strong predictor of what the relationship will look like once your review is underway.

The Major EU MDR Notified Bodies in 2025

While the landscape continues to evolve, the following Notified Bodies have broad MDR designation and are among the most widely used for Class II and III medical devices in Europe.

TÜV SÜD (NB 0123, Germany) has one of the broadest designation scopes and significant experience across active, implantable, and software-based devices. BSI Group Germany (NB 0086) is well established in orthopaedics and cardiovascular devices. TÜV Rheinland (NB 0197) covers a wide range of active and non-active devices. Dekra Certification (NB 0124) has broad scope including combination products. GMED in France (NB 0459) is a strong option for manufacturers targeting the French-speaking market or with European headquarters in France.

Always verify current designation status and scope in NANDO before making any decision, as designations are subject to change.