European
Compliance Platform
European
Compliance Platform
Acceptance status, estimated queue times, and certification timelines for Notified Bodies designated under MDR 2017/745 — updated from EC 18th NB Survey (March 2026) and official NB publications.
| Notified Body | NB ID | MDR Classes | Status 2026 | New Clients | Est. Total Timeline |
|---|---|---|---|---|---|
BSI BSI Group Netherlands B.V. |
0086 / 2797 | IIa · IIb · III · IVD · SaMD | Accepting✓ VERIFIED | No capacity restrictions for any device type or class. Published April 2026. | 13–18 months✓ |
DNV DNV MEDCERT GmbH |
0482 | IIa · IIb · III | Accepting~ EST. | No intake restrictions reported. Focus on Class II–III. 20+ years in medical devices. | 13–18 months~ |
NSAI National Standards Authority of Ireland |
0050 | IIa · IIb · III · IVD | Accepting~ EST. | Actively marketing to SMEs and large companies. Accessible entry point. No restrictions reported. | 9–18 months~ |
GMED LNE-GMED, Paris |
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~ |
TÜV SÜD TÜV SÜD Product Service GmbH |
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~ |
TÜV Rheinland TÜV Rheinland LGA Products GmbH |
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~ |
Dekra DEKRA Certification B.V. |
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~ |
SGS SGS Belgium NV / SGS FIMKO |
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: EC 18th NB Survey, March 2026 — covering 51 designated Notified Bodies across the EU. 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, EC 18th NB Survey aggregate data (48% of certificates issued within 13–18 months). Per-class medians not publicly published — figures are industry estimates.
As of May 2026, BSI (NB 0086/2797) 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.
The EC 18th NB Survey (March 2026) shows 48% of MDR certificates are issued within 13–18 months of application. 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.
ECP routes your device description — class, GMDN/MDD 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 EUDAMED searches.
Submit a request — ECP checks live NB availability across its network
Describe your device once. ECP matches it to Notified Bodies with current capacity and designation scope for your product class. Receive structured responses with timelines and next steps — without cold outreach.