European
Compliance Platform
European
Compliance Platform
What It Means for Medical Device Manufacturers
Commission Implementing Regulation (EU) 2026/977 establishes, for the first time, legally binding requirements on how Notified Bodies must quote, assess, and report on conformity assessment activities under MDR and IVDR. It introduces standardised quotation formats, maximum certification timelines, hard limits on clock-stop interruptions, and mandatory annual public reporting on NB costs and performance.
Key fact: Expiry of a maximum timeline under IR 2026/977 is not sufficient grounds for a Notified Body to refuse to issue a certificate. The timeline caps are enforceable obligations on the NB, not manufacturer deadlines.
| Aspect | Before 2026/977 | After 2026/977 |
|---|---|---|
| NB quotation format | Unstructured — NBs issued whatever level of detail they chose | Standardised 4-element format mandatory: itemised costs, timeline, audit fees, hourly rates only where duration unpredictable |
| Fee increase notification | No obligation — manufacturers discovered increases at invoicing | Increases >10% require advance written notice with justification before charging |
| Pre-application dialogue | NB discretion — often chargeable or unavailable | Structured dialogue at no additional cost — NBs are required to offer this |
| Maximum assessment timeline | None — some NBs took 180–400+ days with no ceiling | QMS audit: 120 days · Technical docs: 90 days · Decision: 20 days |
| Clock-stop interruptions | Unlimited — NBs could pause indefinitely, as often as needed | Hard cap per stage: e.g. QMS 4 stops + 2 per additional site; once cap reached, clock runs continuously |
| Recertification info | Full re-submission often required regardless of changes | Manufacturer confirms unchanged information; NB cannot re-request what is already on file |
| Quote validity | NB discretion | Minimum 90 days (implied by structured process requirements) |
| Public performance data | None — no basis to compare NB speed or cost | Annual reports with median costs and completion rates published by 30 April each year (from 2028) |
Establishes a two-step process. Before issuing any quote, NBs must collect standardised information: manufacturer identity and SME classification, all QMS site locations with headcount, device description, risk class, and conformity assessment procedure type. The quotation itself must contain: (1) itemised costs split between QMS and technical documentation; (2) typical surveillance and unannounced audit costs; (3) estimated additional costs with hourly rates only where duration cannot be predetermined; (4) estimated timeline. For recertifications and change applications, manufacturers may confirm unchanged information is still valid — NBs cannot re-request it.
Sets binding maximum durations: QMS audit (Annex IX/XI) — 120 days; technical documentation verification — 90 days; decision and certificate issuance — 20 days. For substantial changes: scope review 30 days, additional activities 90 days. For recertification: product and QMS assessment each 90 days, re-issuance 20 days. QMS audits and technical documentation verification under Annex IX may run in parallel. Timeline starts the day after contract signing.
Clock stops when the NB sends a formal request for manufacturer information. Each assessment stage has a hard cap on interruptions — once the cap is reached, the clock runs continuously regardless of outstanding queries. Carve-outs (do not count against cap): waiting for EMA opinions, expert panel consultations, or EU reference laboratory opinions. Manufacturers and NBs may agree on rolling technical documentation submission with structured additional interruption allowances for complex multi-site applications.
NBs must establish internal monitoring systems tracking: percentage of activities completed within maximum timelines, median duration from application to certification (excluding clock-stops), median total costs in euros, and application statistics (received, accepted, rejected, pending). Annual reports published by 30 April each year on the NB's public website, with simultaneous submission to the national designating authority and the Commission. First reports due 30 April 2028 covering 2027 data.
Defines minimum documentation for product certificate recertification: list of all changes since previous certificate, PSUR summaries, FSCA history, updated clinical evaluation, and harmonised standard changes. QMS recertification assessment must cover audit coverage adequacy, surveillance trends, and resolution of previous non-conformities. Both product and QMS assessments: 90-day maximum, certificate re-issuance within 20 days of positive decision. Applies to certificates expiring after 25 November 2027.
Commission Implementing Regulation (EU) 2026/977, published 5 May 2026, establishes standardised quotation procedures, binding maximum certification timelines, hard clock-stop limits, and annual public reporting requirements for Notified Bodies conducting conformity assessment under MDR 2017/745 and IVDR 2017/746. It is the first legally binding operationalisation of the transparency obligations that existed in principle in MDR Annex VII.
No. The regulation applies prospectively. Articles 1–3 apply only to agreements signed on or after 25 February 2027. Contracts signed before that date continue under previously applicable rules. There is no retroactive application. However, manufacturers can voluntarily negotiate IR 2026/977-aligned terms into existing contracts before the mandatory date.
Article 2 sets binding caps: QMS audit (Annex IX/XI) — 120 days; technical documentation verification — 90 days; decision and certificate issuance — 20 days. For substantial changes: scope review 30 days + additional activities 90 days. For recertification: both QMS and product assessment within 90 days each, re-issuance within 20 days. Critically, expiry of any maximum timeline does not justify an NB's refusal to issue a certificate.
Yes. IR 2026/977 applies equally to Notified Bodies designated under both MDR (EU 2017/745) and IVDR (EU 2017/746). All requirements — standardised quotations, maximum timelines, clock-stop limits, and annual public reporting — apply to both medical device and in vitro diagnostic conformity assessment.
From April 2028, every NB must publish annual reports showing median assessment costs in euros and median completion times excluding clock-stops. This enables direct, like-for-like comparison before committing to a contractual relationship — something that was previously impossible. Combined with the standardised quotation format, manufacturers can now compare genuine binding cost and timeline commitments across NBs.
Submit a request on ECP — compare NB quotes under the new rules
ECP routes your device description to Notified Bodies with current capacity and matching designation scope. Receive structured responses with cost and timeline estimates — side by side.
Submit one structured request on ECP and receive proposals from relevant EU compliance service providers. Free, no commitment.