UK & EU MDR and IVDR Regulatory Support for Medical Devices & IVDs
For manufacturers who need defensible evidence, structured regulatory strategy, and fewer audit surprises.
1,000+Regulatory Submissions across the UK and EU
Reviewed by
over 20
Different Notified Bodies
10+ years
Supporting Clients Across Full Device Lifecycles
See how we structure evidence across regulatory, clinical, post-market and NB interactions to support device and IVD manufacturers
Discuss your current regulatory position and leave with clear next steps. No obligation.
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![Headshot of a senior regulatory leader supporting SciMed's medical device expertise.]()
"SciMed has been a trusted partner since day one. Their clinical evaluation expertise gave us confidence through multiple audits, and their reliability has made them an extension of our own team."
James Davis - Head of Quality and Regulatory; Caristo Diagnostics
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![Headshot of a co-founder endorsing SciMed's regulatory solutions.]()
"They understood where we were and what we needed; no oversell, just solid work delivered with minimal fuss. It gave us confidence in our classification and next steps."
Miles Payling - Co-Founder; C the Signs
Services
Clinical Evaluation
Our Clinical Evaluation approach combines scientific rigour with practical regulatory insight. We guide you through MDR requirements step by step, ensuring your clinical evidence is robust, defensible, and regulator-ready.
Post-Market Services
Post-market obligations do not end at certification. Our post-market approach structures your PMS Plan, PMCF/PMPF, PSUR and SSCP into a single, coherent surveillance system. We ensure your real-world data feeds back into your technical file continuously and traceably.
Performance Evaluation
Our Performance Evaluation approach applies IVDR-specific practice to your scientific validity and analytical & clinical performance data. We structure your evidence systematically, ensuring every claim is traceable, substantiated, and ready for scrutiny.
Risk & Biological Evaluation
Our Risk and Biological Evaluation work applies ISO 14971 and ISO 10993 frameworks to your specific device and materials. We build risk files that are structured, traceable, and engineered to withstand Notified Body review.
Regulatory Strategy
Our Regulatory Strategy service maps your device classification, applicable standards, and market pathway before a single document is drafted. We give you a clear, costed roadmap so resources go where they deliver most.
Notified Body & Market Access
Our Notified Body support manages every stage of your conformity assessment; from initial application and audit preparation through to certificate issue. We prepare your technical documentation and support you through remediations to the standard auditors expect.
SciMed’s MedTech Horizon
A Monthly Regulatory Briefing for MedTech Leaders
One concise email each month analysing emerging MDR/IVDR expectations, Notified Body trends, and post-market audit signals.
Designed for regulatory and quality leaders who need clarity, not commentary.
Each Issue Includes:
Regulatory signal analysis (what auditors are focusing on now)
Practical tools or checklists you can apply immediately
Strategic commentary to support internal decision-making
Read by regulatory and quality leaders preparing for MDR and IVDR audits.
About SciMed Consultancy
How We Work
Our approach is built on three principles:
Scientific rigour: Every conclusion traceable, defensible, and evidence-led
Organised systems: Documentation structured to withstand audit scrutiny
Long-term partnership: Support aligned to your full product lifecycle, not single deliverables
>> Learn More About Our Approach
SciMed Consultancy Ltd supports medical device and IVD manufacturers across the UK and EU with structured, defensible regulatory solutions. Our work spans clinical evaluation, performance evaluation, post-market systems, risk management and regulatory strategy; grounded in current MDR and IVDR review expectations.
Our team has supported over 1,000 UK and EU regulatory submissions and worked across more than 20 Notified Bodies. We remain actively engaged with regulatory developments to ensure our guidance reflects real-world review expectations.