Notified bodies
Annex VII-ready certification. Every hour on record.
One secure workspace with the manufacturer, where the clock counts only assessor time, every pause is documented, and AI prepares the reading so your assessors can focus on judgement.
New rules, a tighter clock and too little time for judgement.
Every certification hour must now be documented.
Under Implementing Regulation (EU) 2026/977, notified bodies record the time spent on each certification task, excluding the manufacturer’s time to prepare the dossier and answer non-conformities.
Three rounds, then the clock is the issue.
Work must be organised so there are at most three rounds of non-conformities, and every legitimate pause must be justified on record.
Assessors spend their hours on the wrong work.
Chasing documents over email and reading content against requirements leaves less time for the technical judgement only an assessor can give.
The MDR/IVDR review, stage by stage — and where the time goes.
Application and contract review
Time goes to
matching qualified people to codes and planning capacity.
Completeness check
Time goes to
manually screening large dossiers, and the round trips when something is missing.
Technical documentation
Time goes to
finding the evidence for each requirement across hundreds of documents.
Clinical / performance evaluation
Time goes to
tracing every clinical claim back to its source data.
QMS audit
Time goes to
evidence exchange around the audit, and chasing corrective actions by email.
Decision, certificate and surveillance
Time goes to
assembling a decision-ready file from scattered records.
Non-conformities are issued, answered and closed at every stage — across email, shared drives and spreadsheets, with no single audit trail.
The clock runs from application to decision, and Annex VII requires you to monitor and evidence it.
Four dates under Implementing Regulation (EU) 2026/977.
25 Feb 2027
Quotations, maximum timelines and clock-stops (Arts 1–3)
25 May 2027
Monitoring system (Art 4(1)–(3))
25 Nov 2027
Re-certification (Arts 5–7)
1 Jan 2028
Annual public reporting (Art 4(4))
How ComplAi keeps every certification Annex VII-ready.
Secure data rooms with the manufacturer.
Document exchange, questions and non-conformities in one place, with access control and a complete audit trail.
A clock that documents itself.
Defined digital events stop and restart the time counter when non-conformities are issued and rectified. You see who did what, and when — ready for your designating authority.
AI assistance, assessor decisions.
Completeness checks before review starts, evidence scored with links to the source passages, and draft findings and reports. The assessor reviews, edits and signs.
Surveillance and re-certification build on the same record.
Stay compliant as rules change — changes only, year on year.
Certification today, and how it runs in ComplAi.
Today
In ComplAi
Data stuck in silos, downloaded and prepared ad hoc for each audit
Read documentation shared between the notified body and the manufacturer/authorised representative in a common repository
Little engagement from the manufacturer, inefficient collaboration
ComplAi data rooms enable seamless collaboration, both within the teams on each side and across them, with contextual messaging, handling of non-conformities, and internal and shared ticketing
Evidence checked and questions answered by hand
Evidence first checked by AI, then the assessor makes the final check and decides
Control and visibility only during the audit
Continuous visibility and control throughout the certificate validity period
DNV, one of the largest notified bodies, uses ComplAi for all its medical device certification.
- 80% efficiency gain assessing QMS documentation
“Seamless collaboration saved 60% of my time minimising email and document exchanges.”
Frequently asked questions
Does AI make conformity decisions?
No. ComplAi assists assessors; every decision and signature stays with them. Our use of AI follows UKAS and DAkkS guidance for AI in conformity assessment: human oversight, cited evidence and a full audit trail.
How do you protect manufacturer files?
Secure data rooms with access control and a complete audit trail. ComplAi is ISO 27001 certified and GDPR compliant.
How is the AI validated, and how does it fit the EU AI Act?
Every answer is grounded in the submitted documents and cited to the source passage, results are reproducible, and a human reviews every output — in line with UKAS and DAkkS guidance.
Where is our data hosted?
All data is hosted in the EU.
Be Annex VII-ready before February 2027.
See how DNV runs medical device certification in ComplAi.