Data Asset · Updated May 2026
Acceptance status, estimated queue times, and certification timelines for Notified Bodies designated under MDR 2017/745 — based on the Commission's notified body surveys and official NB publications.
| Notified Body | NB ID | MDR Classes | Status 2026 | New Clients | Est. Total Timeline |
|---|---|---|---|---|---|
| 2797 | IIa · IIb · III · IVD · SaMD | Accepting✓ VERIFIED | No capacity restrictions for any device type or class. Published April 2026. | 13–18 months✓ | |
| 0482 | IIa · IIb · III | Accepting~ EST. | No intake restrictions reported. Focus on Class II–III. 20+ years in medical devices. | 13–18 months~ | |
| 0050 | IIa · IIb · III · IVD | Accepting~ EST. | Actively marketing to SMEs and large companies. Accessible entry point. No restrictions reported. | 9–18 months~ | |
| 0459 | IIa · IIb · III · IVD | Accepting~ EST. | 25+ years in medical device certification. Among lowest published fee rates (€278–361/hr). No intake moratorium reported. | 13–18 months~ | |
| 0123 / 2443 | IIa · IIb · III · IVD · SaMD | Limited~ EST. | Most in-demand NB. 750+ staff, full scope. Intake queue 6–12 months before review begins. | 19–30 months~ | |
| 0197 | IIa · IIb · III · IVD | Limited~ EST. | Actively accepting applications (€2,480 application fee). Among larger NBs — intake queues apply. No formal moratorium. | 18–26 months~ | |
| 0344 / 0124 | IIa · IIb · III · IVD | Limited~ EST. | Named among "most in-demand" NBs. NL and DE entities. No official intake statement but backlog context applies. | 18–26 months~ | |
| 1639 | IIa · IIb · III · IVD · Annex XVI | Selective~ EST. | Actively soliciting new MDR clients (May 2026 marketing). IVDR lead time 18–24 months quoted. Targeted acceptance. | 13–24 months~ |
Source: Commission notified body survey (18th survey, data up to 31 October 2025) — covering 52 designated Notified Bodies. The 20th survey (data up to 28 February 2026, 53 NBs) reports 32,898 applications and 18,010 certificates. An additional 8% decline in qualified NB assessors (Team-NB 2025 Survey) means the gap between applications and certifications is unlikely to close significantly before 2028.
| Device Class | Typical Duration | Notes |
|---|---|---|
| Class IIa | ~13–18 months | Lower-risk devices; may be faster at smaller NBs (NSAI, GMED) |
| Class IIb | ~13–18 months | Up to 24 months for implantable and active implantable devices |
| Class III | ~18–24 months | Up to 30 months for novel or combination products; BSI TDA alone: 6 months |
| SaMD (Software) | ~13–18 months | Depends on AI/ML involvement; full GSPR compliance check required |
Source: Team-NB FAQ and the Commission's 20th notified body survey (March 2026), in which 62% of NBs reported 13–18 months to issue a new QMS certificate and 51% reported 13–18 months for QMS plus product certificates. Per-class medians are not publicly published — figures are industry estimates.
As of May 2026, BSI (NB 2797, BSI Group The Netherlands B.V.) has officially confirmed no capacity restrictions for MDR and IVDR applications of any device type. DNV, NSAI, and GMED are also reported as accessible. TÜV SÜD, TÜV Rheinland, Dekra, and SGS are accepting selectively with intake queues of 6–12 months before formal review begins. No major NB has issued a full moratorium as of mid-2026.
In the Commission's notified body survey of March 2026, 62% of NBs reported 13–18 months to issue a new MDR QMS certificate and 51% reported 13–18 months for QMS plus product certificates (31% reported 19–24 months). At the most in-demand NBs, an additional 6–12 month intake queue before formal assessment extends total time to 19–30 months. Applications submitted in mid-2026 should plan for completion in late 2027 at earliest. BSI's verified data shows their QMS audit within 2 months and technical documentation assessment within 1–6 months.
For Class IIa devices, NSAI, GMED, and DNV are generally reported as more accessible with shorter intake queues. BSI is the only NB with officially published lead times — their data shows Class IIa technical documentation assessment typically under 1 month, with total certification in 13–18 months. For lower-risk Class IIa devices with complete documentation, these NBs represent the fastest realistic route in 2026.
Yes, but switching resets the timeline. You must withdraw the application from the current NB, transfer documentation to the new NB, and the new NB performs a full application review from scratch. Previous assessment work is not transferred. This typically adds 6–12 months. Switching is only advisable if the original NB has materially delayed without justification or if a significant scope mismatch is identified. Under IR 2026/977 (from February 2027), the maximum timeline rules will make delays more legally constrained.
AFINA routes your device description — class, EMDN code and MDR designation codes, target markets, and documentation status — to Notified Bodies that have indicated availability and whose designation scope matches your product. You receive direct NB responses with scope confirmation, estimated timelines and next steps, without cold outreach or manual searches.
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