European
Compliance Platform
European
Compliance Platform
Avoid Notified Body delays and reduce certification time
In the Commission's 20th survey, 51% of responding NBs reported a 13–18 month average and 31% reported 19–24 months from written agreement to new MDR certificate issuance. These are NB-level averages, not a promise for a specific device. Reduce avoidable delay by checking NANDO scope early, preparing a complete application and obtaining a device-specific written estimate.
Three factors drive MDR certification timelines: capacity and scheduling at Notified Bodies; scope mismatch — the NB's NANDO designation does not cover the applicable device or procedure codes; and incomplete documentation that triggers necessary follow-up. Manufacturers can reduce all three risks by verifying scope, requesting realistic estimates and completing a readiness review before formal application.
There is no authoritative EU ranking of the fastest notified body, and sector-wide survey data does not establish current intake for a specific device. Start with the live NANDO designation scope, then ask each eligible NB for a device-specific application decision, quotation and estimated timeline. See the tracker for public evidence and verification links:
Build the plan from the Commission's current survey distribution, the complexity of the device and written estimates from eligible NBs. Because the survey reports NB-level averages, add contingency for application completion, contracting, site scheduling, justified interruptions and any external consultation.
Not every NB covers every MDR code and conformity-assessment procedure. Check the live NANDO designation first, then describe the device, intended purpose, risk class, technologies and sites accurately when requesting a quotation. ECP can route that structured request to potential providers, but the NB must confirm scope and intake.
Under IR 2026/977 from 25 February 2027, an NB may interrupt a stage for non-compliances or duly justified questions necessary for assessment. Article 3 limits the number by stage but also permits additional cases and duly justified written extensions. A complete technical file reduces avoidable requests; include the clinical evaluation, current risk-management file, GSPR checklist, applicable standards evidence and UDI documentation.
Annex IX, X and XI routes have different eligibility and assessment requirements. Under Article 2 of IR 2026/977, QMS auditing and product verification carried out under Annex IX must run in parallel, provided the technical-documentation input needed to develop the audit programme is taken into account. This does not mean Annex IX is automatically the fastest or available route for every device.
Use the NB's pre-application process to confirm designation scope and supply the information needed for a reliable quotation. Article 1 of IR 2026/977 requires the NB's structured dialogue procedures to cover aspects relevant to issuing the quotation. It does not create a general right to free consulting or require the NB to pre-assess the technical file.
Annex XI (technical documentation assessment by sampling) may be applicable for certain Class IIa low-risk devices. This involves a less intensive NB review than full Annex IX and can significantly reduce assessment time and cost for eligible products. Verify eligibility with your NB during the pre-notification stage — not all Class IIa devices qualify, but for those that do, this pathway is consistently faster.
EUDAMED registration — obtaining your SRN, assigning a Basic UDI-DI, creating device records — does not require a completed NB certificate for most steps. Start the EUDAMED registration process during NB review, not after. Waiting until after certificate issuance to begin EUDAMED registration adds 4–10 weeks before you can legally place the device on the EU market. See the full EUDAMED registration guide for step-by-step instructions.
Commission Implementing Regulation (EU) 2026/977 applies from 25 February 2027, subject to its transitional provisions. Article 2 sets 30 days from complete application to contract signature, 120 days from the first audit-programme activity through final QMS review, 90 days from the start of technical-documentation assessment through final product review, and 20 days after the last relevant final review for decision and certification. Article 3 interruptions can pause those periods. Articles 1–3 do not apply where the written agreement for that conformity-assessment procedure was signed before 25 February 2027. See the official regulation.
Yes, but switching is not a guaranteed speed strategy. The incoming NB must perform enough assessment to support its own decision, while the manufacturer must manage withdrawal, certificate and surveillance implications, information transfer and new contracting. Obtain a written transition plan from both NBs before acting.
For procedures in scope from 25 February 2027, IR 2026/977 adds maximum stage timelines and written interruption rules. It does not guarantee an overall calendar completion date because each stage has its own start point and Article 3 permits interruptions.
The Commission's 20th NB Survey, published 2 July 2026 with data to 28 February 2026, reports that 51% of responding NBs averaged 13–18 months and 31% averaged 19–24 months from written agreement to new MDR certificate issuance. The distribution is useful for planning, but individual timelines depend on device scope, sites, evidence and interruptions.
Common avoidable causes are late NB selection, incomplete application or technical documentation, and choosing an NB whose NANDO designation does not cover the applicable device and procedure codes. Verify scope and data readiness before lodging the formal application.
There is no authoritative EU ranking of the fastest notified body. Capacity varies by designation scope, device technology, sites, route and application completeness. Verify live NANDO scope and request device-specific quotations and timelines from several eligible NBs before lodging the formal application. See the NB Capacity Tracker 2026 for public sources and verification guidance.
Yes, but the incoming NB must perform enough work to support its own conformity-assessment decision, and transfer arrangements depend on the procedure, certificates and contracts. Treat switching as a regulatory project, not a guaranteed speed shortcut. For in-scope procedures from 25 February 2027, IR 2026/977 adds maximum stage timelines and interruption rules.
No — submitting formal applications to multiple NBs simultaneously is not permitted under MDR. Only one NB may hold an active conformity assessment contract for a given device at a time. However, requesting quotes and pre-application information from multiple NBs before signing a contract is recommended to compare scope, timelines, and costs.
Find an eligible Notified Body and verify intake
Submit one request on ECP describing your device class and scope. ECP matches it to Notified Bodies with current intake availability — receive structured responses with timelines and next steps, without cold outreach or manual EUDAMED searches.