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EU MDR & IVDR
Gap analysis to full compliance.
The regulations replaced the old directives with far deeper requirements for clinical evidence, post-market surveillance and technical documentation, and enforcement has tightened across Europe.
Overview
Gap analysis to full compliance
We start with a structured gap assessment against your current technical file, then hand you a costed remediation plan your notified body will recognise, and we can staff the remediation itself.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
Capabilities
How the engagement runs
Gap Assessment
Technical documentation, clinical evidence and PMS reviewed against the applicable annexes.
Remediation Plan
Findings ranked by risk, each with an owner, an effort estimate and a deadline.
Execution Support
Writers, engineers and QA specialists to close the gaps rather than just list them.
Notified Body Readiness
Mock review and response preparation before the file goes in.
What a gap assessment covers
Every assessment is scoped to your device class and portfolio, but most cover the same core areas of Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR):
- General safety and performance requirements. An Annex I checklist that points to real evidence for each applicable requirement.
- Technical documentation. Structure and completeness against Annexes II and III, including design and manufacturing information.
- Clinical or performance evidence. The clinical evaluation or performance evaluation, and whether the evidence supports the claims made.
- Post-market surveillance. The PMS plan, periodic safety update report or post-market surveillance report, and vigilance procedures.
- Identification and registration. UDI assignment and EUDAMED registration obligations.
- Quality system and responsibilities. Quality system alignment and the role of the person responsible for regulatory compliance.
- Labelling. Labels and instructions for use against the current requirements.
The dates that drive the work
For eligible legacy devices, the MDR transition runs to 31 December 2027 for class III and class IIb implantable devices and to 31 December 2028 for other classes. Under the IVDR, legacy devices have until 31 December 2027, 2028 or 2029 depending on class. These extensions only apply where the manufacturer met the conditions, including a compliant quality management system and a timely notified body application. The European Commission proposed further targeted amendments in December 2025, which are still going through the legislative process. Our deadline tracker keeps the current dates in one place.
Who we help
We work with manufacturers moving legacy devices to MDR or IVDR certification, companies preparing a first CE marking, and teams responding to notified body findings. Where the gap list is long, we can staff the remediation with writers, engineers and quality specialists rather than leaving you with a report.
Send us one requisition.
Judge us on the shortlist, not the sales deck.