The Notified Body capacity crisis — strategy guide for 2026

The numbers are stark — and they are getting worse

Under the MDD, there were over 80 Notified Bodies designated across Europe. Under EU MDR, that number has shrunk to approximately 40. The same pool of NBs must now process a dramatically higher volume of applications — because MDR technical documentation requirements are far more demanding than MDD, and the review process itself is more rigorous.

The result is predictable. Major NBs are reporting average review times of 13 to 18 months from application acceptance to certificate issuance. And before acceptance, intake queues at the most in-demand NBs — BSI, TÜV SÜD, DEKRA — can run 6 to 12 months. From first contact with an NB to receiving your EU Certificate of Conformity, you should budget 24 months. In some cases longer.

Why the queue is getting longer, not shorter

MDR technical files are 3–5x longer than MDD. A typical SaMD technical file under MDR runs 300–600 pages. NBs take significantly longer to review each application simply because there is more to review.

NB capacity has not grown proportionally. Becoming designated under MDR requires NBs to meet higher competency requirements than under MDD. Many smaller NBs could not or chose not to seek MDR designation. The result is fewer NBs with higher standards handling more work.

Legacy device transitions are overwhelming the system. Thousands of MDD-certified devices still need to transition to MDR. Many manufacturers delayed, expecting further deadline extensions. There are no further extensions for most device classes. The resulting application surge is landing on already-stretched NBs.

Poor application quality creates rework cycles. NBs frequently stop the clock and issue major non-conformities when documentation is incomplete or does not meet MDR standards. Every non-conformity cycle adds weeks or months to the timeline. Applications with poor technical files effectively jump back in the queue.

How to choose a Notified Body that can actually deliver

Not all NBs are equal — and in the current environment, choosing the wrong one can cost you a year. Here is what to evaluate:

• Designated scope for your device type: Verify that the NB is actually designated to certify your specific device class and type under EU MDR. Not all NBs hold authorisation for all software categories. Check the NANDO database (New Approach Notified and Designated Organisations).
• Current intake queue: Ask directly — "How long before you can accept my application?" The honest answer tells you more than any marketing material. Some NBs are actively limiting intake to manage their existing backlog.
• SaMD-specific experience: Ask how many SaMD and AI medical device certificates the NB has issued under EU MDR. Software applications require reviewers with specific IEC 62304 and clinical evaluation expertise. A hardware-focused NB may have the scope but lack the right reviewers.
• Geographic and language considerations: Some NBs have strong preferences for manufacturers in their home country or region. Some conduct reviews primarily in German. Factor this into your decision — working with an NB whose primary language is not yours creates avoidable friction.
• Communication responsiveness: Test this during the selection process. How quickly do they respond to pre-submission enquiries? Slow pre-submission communication is a reliable predictor of slow review communication.

Six strategies to cut your certification timeline

1. Engage NBs 18+ months before your target certification date. The earlier you initiate contact and express interest, the earlier you get into their pipeline. Many NBs offer pre-submission meetings that, while not guaranteed, help position your application for faster intake.
2. Submit a complete, polished technical file on day one. The single biggest cause of timeline extensions is incomplete or poor documentation. NBs stop the clock on incomplete submissions. Every query cycle adds 6–12 weeks. A complete, well-organised, well-written technical file gets reviewed faster and generates fewer non-conformities.
3. Conduct an independent pre-submission audit. Before submitting to an NB, have your technical file reviewed by an independent regulatory consultant who knows what NBs look for under EU MDR. Finding gaps before submission is dramatically cheaper and faster than receiving major non-conformities after.
4. Respond to NB queries within 48 hours. Many manufacturers respond slowly to NB queries, treating them as low priority. Each day of delay extends your timeline. Build an internal process for fast-tracking NB responses.
5. Consider less congested NBs. Smaller or newer NBs — those that became designated more recently — often have significantly shorter queues than BSI or TÜV SÜD. They are subject to the same competency requirements and issue legally equivalent certificates. For many SaMD applications, a less well-known NB with a 3-month queue is a better choice than a major NB with a 12-month queue.
6. Plan for the December 2025 simplification proposal. The EU Commission's proposal to remove the fixed five-year recertification cycle, if adopted, will reduce NB workload in the medium term. Plan your long-term certification strategy with this in mind — but do not rely on it for your 2026–2027 applications.

What good pre-NB preparation looks like

The companies that move through NB review fastest are the ones that treat NB submission as the final step in a well-executed process — not the beginning of the documentation work. A complete, submission-ready technical file under EU MDR includes:

• A clear, specific intended use statement and device description (this is the anchor of everything — vague intended use generates cascading queries)
• Complete Rule 11 classification justification with written rationale
• Technical Documentation per Annex II with all required sections complete, including software documentation per IEC 62304
• Clinical Evaluation Report meeting MDCG 2020-1 requirements — including a systematic literature search, not just a summary
• ISO 14971:2019-compliant risk management file — not the 2007 version
• Post-market surveillance plan that is specific to your device, not generic
• Declaration of Conformity aligned to your classification and conformity assessment route

Preparing all of this — including a solid Clinical Evaluation Report, ISO 14971:2019 risk management file, and IEC 62304 documentation — before engaging an NB is not just best practice — in 2026, it is the difference between receiving your certificate on time and missing the window.