Not sure where you stand? Start with a Gap Assessment.
A fixed fee report on exactly what your technical file needs to pass, powered by our proprietary IVDR Gap Analysis tool. You get a clear list of what is missing, what is at risk and what to fix first.
What is included
- A line by line check of your technical file against the regulation
- Risk rated findings, so you know what is urgent and what can wait
- A prioritised remediation list you can act on immediately
- A view across UK and EU requirements, not just one market
- A 30 minute call to walk through the findings
How it works
Four steps from uncertain to a clear plan
You share your file
A short intake on your device, its class and your target markets. We tell you exactly what to send.
We run the analysis
Your documentation goes through our proprietary IVDR Gap Analysis tool and a senior review. Nothing automated and left there.
You get the report
A written, fixed fee report: what is missing, what is at risk, and what to fix first, in order.
You decide the next move
Take the plan and run it yourself, or have us remediate. No retainer, no lock in.
Why now
The deadlines do not wait for a ready file
Every date below can take a device off the market if you arrive unprepared. A Gap Assessment tells you which ones you are exposed to.
EUDAMED
First four modules become mandatory. Actor registration and your SRN must be in place.
EUDAMED devices
Devices already on the market before 28 May 2026 must be registered in the database.
MHRA CE recognition
Consultation on indefinite recognition of CE marked devices in Great Britain closed 10 April 2026. No outcome yet.
EU MDR
Class III and IIb implantable by Dec 2027, the rest by Dec 2028, for devices that met the 2024 transition conditions.
EU IVDR
Class D by Dec 2027, Class C by Dec 2028, Class B and A sterile by Dec 2029.
CE marks in Great Britain
Notified Body certified directive devices accepted to 30 June 2028, EU MDR and IVDR devices to 30 June 2030.
Next deadline
The next regulatory deadline
Get started
Request your Gap Assessment
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