UK & EU MDR and IVDR Regulatory Support for Medical Devices & IVDs

For manufacturers who need audit-ready evidence, clearer regulatory strategy, and fewer compliance surprises.

Confidential. Leave with clear next steps.

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 support MDR CERs, PMS & NB Audits

"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
"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

View Client Success Stories

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.

>> Clinical Evaluation Support

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.

>> Review your PMS & PMCF Structure

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.

>> Clarify your IVDR Evidence Position

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.

>> Discuss your Risk File & Biological Safety Strategy

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.

>> Map your Regulatory Pathway

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.

>> Prepare for your Next Notified Body Interaction

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

Trusted by MedTech manufacturers preparing for MDR and IVDR audits.

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; always grounded in current MDR and IVDR expectations.

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