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.

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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

  • 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

  • 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

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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.

SciMed’s MedTech Horizon: Three Resources to Help you Stay Audit-Ready

Blog
How to Build a Compliant PMS System
Post-Market Services
How to Build a Compliant PMS System
Post-Market Services

A compliant Post-Market Surveillance (PMS) system is not a reactive process. Under the EU Medical Device Regulation, it must proactively collect, analyse, and feed post-market data back into risk management, clinical evaluation, and corrective actions to demonstrate ongoing safety and performance throughout the device lifecycle.

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Post-Market Services
How to Prepare a Clinical Evaluation Plan Aligned with MDR Annex XIV
Clinical Evaluation
How to Prepare a Clinical Evaluation Plan Aligned with MDR Annex XIV
Clinical Evaluation

Under MDR Annex XIV, the CEP is your anchor document. Define scope, map data, integrate risk and PMS, and show foresight. A robust CEP reassures notified bodies and builds a sustainable compliance framework for product safety and performance.

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Clinical Evaluation
Is Your Clinical Evaluation MDR-Ready?
Clinical Evaluation
Is Your Clinical Evaluation MDR-Ready?
Clinical Evaluation

Is your Clinical Evaluation ready for MDR scrutiny?
This expert guide walks regulatory and clinical affairs professionals through the latest EU MDR expectations under Article 61 and Annex XIV—covering GSPR alignment, evidence standards, equivalence justifications, and audit-readiness strategies.

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Clinical Evaluation
UK PMS Regulations vs EU MDR
Post-Market Services
UK PMS Regulations vs EU MDR
Post-Market Services

With the right updates, existing MDR-compliant systems can be efficiently adapted to meet the new MHRA requirements.

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Post-Market Services

SciMed Consultancy Ltd partners with medical device and IVD companies across the globe to deliver clear, defensible regulatory solutions across the entire product lifecycle. Our expertise spans clinical evaluation, performance evaluation, post-market surveillance & maintenance and regulatory strategy; supporting compliant market access in the EU and UK.

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