How to Choose a Notified Body for CE/MDR — A Practitioner's Checklist

The NB Market in 2025: What Nobody Tells You Up Front

In 2017, when MDR 2017/745 was formally published, there were roughly 80 Notified Bodies recognized under the old Medical Devices Directive (MDD 93/42). By early 2025, only 37 are designated under MDR 2017/745, and 22 under IVDR 2017/746. The European Commission's NB Alerts show average wait times of 14–18 months just to reach an initial review meeting. I have seen Israeli companies pay application fees, sign NDAs, and only then discover that their chosen NB had quietly closed new entries in their device category through 2027.

This is not an impression — it is documented. As of December 2024, BSI Group, TÜV SÜD, TÜV Rheinland, and SGS Belgium hold the largest open-file volumes under MDR. Each has publicly announced temporary intake freezes in specific categories. If you approach the biggest NB assuming that size equals availability, you are in for a rude surprise.

NANDO: The Database You Need to Actually Read

NANDO (New Approach Notified and Designated Organisations) is the European Commission's official database of designated NBs. It is public and free at ec.europa.eu/growth/tools-databases/nando. The problem is that most people open it, find a name, and leave. That is not enough.

What you need to check in NANDO:

• Scope of designation: Every NB is designated for a specific range of EMDN (European Medical Device Nomenclature) codes and MDR Annexes. The designation scope goes down to the Generic Device Group level. An NB designated for surgical instruments (EMDN Q1601) is not necessarily designated for stents (Q11).
• Annexes IX, X, XI: MDR 2017/745 defines three conformity assessment routes — Annex IX (QMS + Technical Documentation), Annex X (Type Examination), Annex XI (Production Quality Assurance). Verify your chosen NB is designated for the exact Annex your route requires.
• Class scope: An NB designated for Class IIa is not automatically designated for Class III. This sounds obvious, but I have seen companies discover this only at the contract stage.
• IVDR vs MDR: If your product is an IVD — including companion diagnostics — the IVDR-designated NB list is far shorter. As of January 2025, only 8 NBs are designated across all IVDR categories D, C, and B.

MDD Legacy Scope: The Trap People Fall Into

Companies that received CE marking under MDD 93/42 before the May 2024 grace period deadline are now under pressure to transition to MDR. The trap: the NB that issued your MDD certificate is not necessarily designated to perform your MDR certification. And even if they are designated — they are under no obligation to prioritize you. I have seen multiple cases where an NB told a long-standing MDD client to join the general queue — 18 months — exactly like a new applicant.

If you are transitioning from MDD to MDR, the right question to ask your current NB is: "Do you have a dedicated transition pathway for existing MDD clients, and what SLA does it guarantee?" If the answer is vague — that is a signal to evaluate alternatives.

Questions Worth Asking in the Initial Discovery Call

The discovery call with an NB is not just an interview where they evaluate you — it runs both ways. These are the questions I ask in every such call:

1. "What is your current lead time from application submission to first review meeting?" — Do not accept "several months." Ask for a number. If they cannot give one, they are too backlogged to manage their own schedule.
2. "How many reviewers do you have designated for MDR Class IIb/III in our device category?" — NBs that expanded their MDR scope quickly sometimes did so with experts migrating from MDD, without specific MDR training. This gives you a sense of team depth.
3. "What is your policy on surveillance audit scheduling and billing for scope changes?" — Many NBs charge additional fees when you modify your QMS between surveillance audits. Scrutinizing this in the contract prevents surprises.
4. "Have you received any EUDAMED suspension notices or Commission audit findings in the last 24 months?" — A direct question that few NBs expect. An NB that underwent a Commission audit and received findings is required to report it. If they are evasive — check the Commission notifications yourself.
5. "What is your process when our submission requires expertise from a sub-contractor?" — MDR permits NBs to use sub-contractors for specialist expertise, but the NB remains responsible. Know if this applies to your file — and ensure it is documented.

Warning Signs of an Overloaded NB

I have worked with NBs since the early 2000s. These are the signs that have prompted me to recommend switching:

• Response time on pre-submission questions exceeding two weeks — if they do not respond quickly before you sign, they certainly will not after.
• Account Manager turnover more than once in six months — points to high internal churn.
• Immediate agreement to every scope item you requested without questions — a competent NB will verify they genuinely have expertise in your device category. Blind agreement is not good news.
• A contract that specifies no SLA for audit stage completion — without this you have no contractual lever if they delay.
• Unwillingness to provide a list of reference clients in a sector similar to yours — good NBs are proud of their portfolio.

Contract Terms to Check Before Signing

Not everyone reads an NB contract word for word. These are the critical clauses:

• Audit lead time SLA: Does the contract define a maximum period between application submission and scheduling of the first audit? Without it, you have no enforcement tool.
• Surveillance audit frequency and billing: MDR requires annual surveillance audits for Class III and Class IIb under Annex IX. What is the price? Is it fixed or day-rate?
• Scope change fees: If you add a product variant or modify a manufacturing process — what does a scope extension review cost?
• Certificate suspension and withdrawal: What is the procedure if the NB decides to suspend your certificate? How much time do you have to respond? MDR Article 58 sets the legal floor, but the details depend on your contract.
• Termination notice period: If the NB closes its operations (as several smaller NBs have done in recent years) — what are they obligated to provide? A minimum transition period? Assistance transferring to another NB?
• Confidentiality clauses: Ensure the technical information you submitted is covered by full confidentiality, including after the agreement ends.

Large NB vs Small NB: The Real Trade-off

The natural inclination for Israeli companies is to pick a large NB — BSI, TÜV SÜD, TÜV Rheinland. The logic: big name equals safety. The reality is more nuanced.

Criterion	Large NB	Small/Mid NB
Availability 2025–2027	Limited — long queues	Often better
Scope coverage	Broad — most MDR categories	Sometimes niche-focused
Personal relationship	Account manager may rotate	Often direct access to expert
Mutual Recognition Agreements	Some large NBs carry MRAs with additional markets	Usually none
Cost	Generally higher	Often more competitive
Organizational stability	High	Some closure/merger risk

My recommendation: for Israeli companies at the initial CE/MDR stage, mid-tier NBs such as Eurofins Product Testing (Belgium), DEKRA Certification (Germany), and IMQ (Italy) often offer a better combination of availability, domain expertise, and cost — particularly for Class IIa and IIb devices.

Five Questions Every Israeli MedTech CEO Should Ask Before Signing

1. Is the NB designated specifically for our EMDN code and for the MDR Annex relevant to our chosen conformity assessment route? — Not "generally for medical devices" — specifically.
2. What is the realistic timeline from application submission to Initial Review meeting — and is that in writing?
3. What is the procedure if the NB's specialist in our device category leaves the organization during the assessment?
4. Has the NB recently conducted an MDR audit in our specific sector — and what were the outcomes?
5. What is the total certification cost — including surveillance audits for the first three years — and how is it priced if we expand scope?

The Two Most Common Mistakes

In twenty-five years of guiding companies through NB selection, two mistakes come up more than any others:

Mistake one: choosing an NB on initial price alone. The initial certification fee is not the real cost. Total Cost of Certification includes surveillance audits, scope extensions, and documentation updates over a 5–7 year certificate lifetime. The cheapest NB on the first submission has cost my clients twice as much when they were forced to switch due to unexpected delays.

Mistake two: applying to only one NB. You are absolutely entitled to send RFQs (Requests for Quotation) to two or three NBs simultaneously. This is not disloyalty — it is professionalism. NBs know the market is competitive.

The NB market in the coming years is a capacity-constrained market. Whoever starts the selection process 18 months before they "need" the CE mark will be in a strong position. Whoever starts when the product is ready for market will discover the market is not yet ready for them.