Clinical evaluation process under EU MDR and UK medical device regulations

EU MDR & IVDR classification support

Medical device classification from Class I to Class III under MDR

Class I to Class III (MDR) & Class A to D (IVDR)

Clinical evidence specialists reviewing and analysing medical device data

Borderline, novel & high-risk classification rationales

Literature-based clinical evaluation and equivalence assessment for medical devices

Classification aligned with MDR Annex VIII and IVDR requirements

Clinical evaluation aligned with MDR Annex XIV and MDCG guidance

Clear rationale for regulatory and audit use

Experience across MEDDEV 2.7/1 Rev 4 and MDR transition for clinical evaluation

Experience across MDR, IVDR, and legacy frameworks

Medical Device & IVD Classification Support

Built for Clear Regulatory Decisions

Medical device and IVD classification determines your regulatory pathway, your evidence requirements, and whether a Notified Body is involved.

We define your classification position clearly, explain the reasoning behind it, and make sure you understand what it means before you commit to the next stage.

Book a 30-Minute Discovery Call
Book a 30-Minute Discovery Call
[Bray Group]
[Caristo Diagnostics]
[C the Signs]
[CooperVision Specialty EyeCare]
[Innovia Medical]
[LifeScan]

What You Get

✅ Classification Strategy,

✅ Rule-by-Rule Assessment,

✅ Borderline & Edge Case Analysis,

✅ Intended Purpose & Claims Review,

✅ Classification Rationale Document, and

✅ Regulatory Impact Summary

  • Headshot of a senior regulatory leader supporting SciMed's medical device expertise.

    “SciMed were able to decipher the MDCG guidance and translate it into what the documentation should look like for auditors.”

    James Davis - Head of Quality and Regulatory; Caristo Diagnostics

  • "We’ve got great confidence going into audits that the documentation will meet what auditors are looking for."

    Liz Gillman - Clinical Compliance Project Lead; LifeScan

  • Headshot of a clinical director endorsing SciMed's regulatory solutions.

    “We wouldn’t be compliant. We wouldn’t be audit-ready.”

    Julie Anne Nicholson - Clinical Director, Innovia Medical

If Your Clinical Evaluation is Unclear, the Entire Submission is at Risk

Under MDR, Clinical Evaluation is one of the most heavily scrutinised parts of a technical file.

If the evidence is not sufficient, the equivalence position is weak, or the reasoning is not clearly supported, the impact is rarely isolated.

It typically leads to:

  • Delays in Notified Body review

  • Requests for additional clinical evidence

  • Rework across multiple parts of the technical documentation

In many cases, this happens even when the report appears structurally complete. The issue is not the format.

It is whether the evaluation presents a clear, defensible position based on the available evidence.

Most teams do not need more content. They need clarity on whether their current evidence position will hold under scrutiny.

What your Clinical Evaluation Actually Needs to Demonstrate

A Clinical Evaluation is not just a document.

It is a structured assessment of whether your device can be supported by the available clinical evidence, and how that position will be interpreted under review.

Our role is to define that position clearly, and present it in a way that is grounded, transparent, and defensible.

Before any report is written, you should know:

  • Whether your evidence is likely to support your intended claims

  • Where the main risks or limitations sit

  • What level of justification will be required

  • Whether additional evidence or PMCF may be needed

Component What this means in practice
Clinical Evaluation Strategy We define how your device should be evaluated under MDR, based on the strength and limitations of the available evidence.
Equivalence Assessment
(if applicable)		 Where equivalence is used, we assess and justify clinical, technical, and biological comparability, including where justification may be limited.
Evidence Identification &
Literature Search		 Structured, traceable searches designed to capture relevant clinical data without over- or under-scoping the evidence base.
Evidence Appraisal & Selection Critical review of the literature to determine what is reliable, relevant, and appropriate to include, not just what exists.
Clinical Evidence & State-
of-the-Art Analysis		 Assessment of safety and performance in the context of current clinical practice, including how your device compares to available alternatives.
Evidence Gap & PMCF Positioning Clear identification of evidence limitations and a structured position on residual risk and post-market requirements.
Clinical Evaluation Report (CER) A complete MDR-aligned report that presents the evidence, the reasoning, and the limitations clearly for regulatory review.

Why Clinical Evaluation Requires More than Document Preparation

A Clinical Evaluation is not assessed on structure alone. It is assessed on the quality of reasoning behind the conclusions it presents.

The difference between an acceptable report and one that is challenged often comes down to:

  • How evidence limitations are handled

  • How equivalence is justified

  • How conclusions are supported and qualified

  • How clearly the overall argument holds together under review

Typical approach vs SciMed’s approach

Typical consultancy SciMed
Literature summary Evidence interpretation
Structured report Defensible argument
"Compliant" output Review-ready positioning

Our role is not simply to produce a document. It is to develop a Clinical Evaluation that reflects:

  • A clear understanding of the device and its intended use

  • A structured & transparent evaluation of the available evidence

  • A position that can be explained and defended if questioned

This is particularly important where evidence is limited, heterogeneous, or requires careful interpretation, which is often the case under MDR.

In some cases, the conclusion of a Clinical Evaluation is not a simple confirmation, but a clear understanding of where the evidence is strong, where it is limited, and what that means for your regulatory pathway.

Our role is to ensure that position is defined early, understood clearly, and presented in a way that can be supported.

Our involvement does not stop at document delivery. Where questions arise during review, we support clarification of the Clinical Evaluation and the reasoning behind it, ensuring your position is clearly understood.

If you're responsible for regulatory compliance, you already know that Clinical Evaluation is where many MDR projects stall. You need a partner who finds the gaps before regulators do.

Worried this is you?

Book a Discovery Call
Book a Discovery Call

We’ll discuss your device, your current evidence position, and what the most sensible next step is likely to be.

We work with a limited number of Clinical Evaluation projects at any one time to maintain quality and consistency.

SciMed’s Services are for You If…

You’re likely a good fit for SciMed’s Clinical Evaluation Services if you recognise yourself here:

  • You're preparing for a Notified Body audit…

    • …and need certainty that your clinical evidence will withstand scrutiny.

  • You're regulatory team is stretched thin…

    • …and can’t dedicate the time require to produce publication-quality Clinical Evaluation Reports.

  • You've received audit findings on your CER…

    • …or clinical data and need expert remediation support.

  • You're a start-up founder…

    • …and need a clear, cost-effective pathway through MDR clinical requirements without derailing your timeline.

  • You value scientific rigour…

    • …and won’t settle for templated reports that regulators see through immediately.

  • You want lifecycle compliance support…

    • …not just a one-time deliverable.

If you're looking for someone to rubber-stamp existing documentation or promise "first-attempt approval," we're not the right fit. Our clients value honest assessment and evidence-based solutions over hollow guarantees.

Yes, I'm a Fit - Book 30 mins
Yes, I'm a Fit - Book 30 mins

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Clinical Evaluation Specialists

  • Headshot of a senior regulatory leader supporting SciMed's medical device expertise.

    Selina McHarg - Senior Analyst, Clinical Evaluation Process Owner

    Selina leads the clinical evaluation process at SciMed, ensuring each project is structured, traceable, and aligned with MDR and IVDR requirements from the outset. She combines a PhD in physiology with over a decade of academic research and regulatory experience, supporting defensible, evidence-grounded clinical and performance evaluation work.

  • Nicola Edwards - Senior Analyst

    Nicola specialises in clinical and biological evaluation, with particular expertise in Software as a Medical Device (SaMD) and complex technical documentation. She combines a PhD in Translational Cardiovascular Science with strong academic and regulatory experience to support MDR and IVDR-compliant evidence strategies across a range of device types.

  • Headshot of a clinical director endorsing SciMed's regulatory solutions.

    Nadhim Bayatti - Senior Analyst

    Nadhim focuses on clinical and performance evaluation for legacy devices and well-established technologies, where evidence interpretation and regulatory positioning are often more complex. He brings over two decades of postdoctoral research experience in neuroscience and molecular biology, alongside a PhD in Developmental Neuroscience, to support clear and defensible evidence frameworks under MDR.

  • Sylvia Lui - Clinical Reviewer

    Sylvia supports the review and validation of clinical evaluations, ensuring consistency, completeness, and alignment with regulatory expectations prior to submission. She combines a PhD in genomics and reproductive biology with extensive postdoctoral research in immunology and maternal–fetal health to strengthen the scientific and regulatory robustness of each deliverable.

Leadership & Project Oversight

  • Headshot of a senior regulatory leader supporting SciMed's medical device expertise.

    Alastair Selby - Founder & Regulatory Consultant

    Alastair leads regulatory strategy, client engagement, and oversight across all Clinical Evaluation projects, ensuring alignment with submission objectives and broader technical documentation requirements. He brings over a decade of consultancy experience and active involvement in international standards development, maintaining alignment with current MDR and IVDR expectations.

  • Anna Le Fevre - Business Manager

    Anna oversees project coordination, financial operations, and client communication across engagements, ensuring delivery is structured, efficient, and well-managed throughout. With over 10 years’ experience in accounting and audit environments, she supports consistent execution and a high-quality client experience.

Are SciMed the Right Fit?

Our approach is typically suited to teams who:

  • Are preparing for MDR or UKCA submission

  • Need a Clinical Evaluation that will withstand detailed review

  • Require structured support with evidence interpretation and positioning

  • Have received Notified Body feedback or audit

It may be less suitable if:

  • You are looking for low-cost document drafting without full evaluation

  • You are looking for high-level guidance only, without progressing towards a defined regulatory or development pathway

Start with a 30-minute Clinical Evaluation discovery call

We begin by understanding your device, your current evidence position, and where you are in the regulatory process. Every project starts with a defined scope, clear timelines, and an agreed evidence strategy before any work begins.

You will leave the call with a clearer understanding of:

  • What your Clinical Evaluation requires

  • An indication of where key challenges may sit

  • A defined next step if you decide to proceed

There is no obligation to continue after the call.

We typically work with a limited number of Clinical Evaluation projects at any one time to maintain quality.

Book a 30-Minute Clinical Evaluation Discovery Call
Book a 30-Minute Clinical Evaluation Discovery Call