European
Compliance Platform
European
Compliance Platform
A public-evidence tracker for MDR notified-body intake. Only current, attributable statements are treated as verified; device-specific availability still requires direct confirmation.
| Notified Body | NB ID | Scope Check | Public Intake Evidence | Current Finding | Timeline Evidence |
|---|---|---|---|---|---|
BSI BSI Group Netherlands B.V. |
2797 (EU NB) | Verify applicable codes in NANDO | Published✓ VERIFIED | July 2026 BSI publication: no restrictions; accepting MDR/IVDR applications for all device types. | Stage lead times published; no total-time guarantee |
DNV DNV MEDCERT GmbH |
0482 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified in this update. | Request device-specific estimate |
NSAI National Standards Authority of Ireland |
0050 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified in this update. | Request device-specific estimate |
GMED LNE-GMED, Paris |
0459 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified. Use the Commission's July 2026 fee-link list for the NB's current published standard fees. | Request device-specific estimate |
TÜV SÜD TÜV SÜD Product Service GmbH |
0123 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified in this update. | Request device-specific estimate |
TÜV Rheinland TÜV Rheinland LGA Products GmbH |
0197 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified. Check its current standard-fee publication via the Commission list. | Request device-specific estimate |
Dekra DEKRA Certification B.V. |
0344 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified for this entity in this update. | Request device-specific estimate |
SGS SGS Belgium NV / SGS FIMKO |
1639 | Verify applicable codes in NANDO | Not verifiedCONTACT NB | No comparable current public intake statement verified in this update. | Request device-specific estimate |
Source: European Commission 20th NB Survey, published 2 July 2026 (data as of 28 February 2026). Application and certificate totals are not one-to-one, so their difference must not be presented as a pending backlog or the ratio as a certification success rate. The reported 13–18 month figure is an average at responding-NB level from written agreement to certificate issuance.
BSI's July 2026 publication states no capacity restrictions and acceptance of MDR and IVDR applications for all device types. This update did not verify comparable current public intake statements for the other named NBs. That does not mean they are closed: ask each NB to confirm availability for the exact device, procedure, technologies and sites.
The Commission's 20th survey reports that 51% of responding NBs averaged 13–18 months and 31% averaged 19–24 months from written agreement to new MDR certificate issuance. These are NB-level averages, not per-class medians or device-specific commitments. BSI separately publishes current stage lead times, including earliest audit scheduling after written agreement.
There is no authoritative EU ranking of the fastest NB for Class IIa. First filter the live NANDO list by the applicable device and conformity-assessment codes, then compare complete-application requirements, earliest contract and audit dates, product-review estimate, permitted interruptions and total cost.
Switching is possible, but the incoming NB must perform sufficient assessment to support its own decision. Plan withdrawal, certificate and surveillance implications, information transfer and new contracting with both NBs. IR 2026/977 applies from 25 February 2027, but its stage timelines have specific start points and permitted interruptions; they do not guarantee an overall completion date.
ECP routes a structured device description — risk class, applicable MDR/IVDR designation codes, technologies, sites, target markets and documentation status — to potential providers. The notified body remains responsible for confirming designation scope, accepting the application and issuing its own quotation and timeline.
Submit a request — ECP checks live NB availability across its network
Describe the device once and receive responses from potential providers. Confirm NANDO scope, current intake, quotation assumptions and timelines directly with the notified body before lodging an application.