Legacy CER Gap Analysis
Find out exactly where your MDD-era Clinical Evaluation Report falls short of MDR Annex XIV and MDCG 2020-13 — with a gap report, claims-to-evidence map, and remediation plan, reviewed and signed off by a qualified expert.
Why Now
The MDR Transition Clock Is Running Out
Legacy MDD-era CERs need to meet MDR requirements before the transition deadlines — and gaps take longer to close than most manufacturers expect.
31 Dec 2027
MDR transition deadline for higher-risk legacy devices (Class III, implantables, certain Class IIb)
31 Dec 2028
MDR transition deadline for most other legacy Class I, IIa and IIb devices
10 days
Turnaround on a Legacy CER Gap Analysis, so you know exactly what's missing before you run out of runway
Built for small device manufacturers
Small manufacturers, no in-house RA team
Class I, IIa and IIb device makers who need an outside expert to tell them exactly where their legacy CER falls short.
MDD-era CERs facing the MDR deadlines
Your CER was written for the MDD, and the transition deadlines (31 Dec 2027 / 2028) mean it needs to be re-assessed against MDR Annex XIV.
Teams who want expert sign-off, not just a tool
AI drafts and organizes the comparison; a qualified human reviews and signs off on every finding before it reaches you.
How It Works
From legacy CER to remediation plan in 10 working days
AI accelerates the comparison and drafting. A qualified human reviews and signs off on every finding before it reaches you.
1
Upload
Share your existing CER and supporting documents
2
Gap report
Findings mapped to MDR Annex XIV and MDCG 2020-13, clause by clause
3
Claims-to-evidence map
Every clinical claim traced to its supporting evidence, or flagged where it is missing
4
Remediation plan
A prioritized, actionable plan to close the gaps — reviewed and signed off by a qualified expert
Fixed-price packages
No hourly billing surprises. Pick the package that matches where your legacy CER stands today.
Founding client offer: the first 3 clients get a Legacy CER Gap Analysis for €1,900 in exchange for a testimonial.
Most popular
Legacy CER Gap Analysis
€2,500–3,500
10 working days
Gap report against MDR Annex XIV and MDCG 2020-13
Claims-to-evidence map for your existing CER
Prioritized remediation plan
Expert review and sign-off on every finding
Full update
CER Update / Literature Review
€4,000–6,000
Literature search protocol
Screening and appraisal tables
Updated CER draft, ready for your sign-off
Builds directly on a prior Gap Analysis where available
Ongoing
Living CER Retainer
€500–1,500
per month
Periodic CER updates as PMS/PMCF data comes in
Ongoing clinical evidence monitoring
No year-end scramble before your next review
Legacy CER Readiness Checklist
A free checklist covering where MDD-era CERs most commonly fall short against MDR Annex XIV and MDCG 2020-13.
We'll only use this to send you the checklist — no newsletter signup.Scope and responsibility
This service uses AI to accelerate document comparison and drafting, with every finding reviewed and signed off by a qualified expert before delivery. As with any CER, the manufacturer remains legally responsible for the clinical evaluation and its conclusions under EU MDR Article 61 — this service supports that work, it does not replace your regulatory responsibility.
Deliverables are based on the documents you provide. We do not represent the gap analysis as a substitute for Notified Body review or a guarantee of certification.