Clinical Evaluation
Clinical Evaluation Readiness Assessment
Clinical Evaluation for Software as a Medical Device (SaMD) Under EU MDR
How to build a clinical evaluation for SaMD under MDR — what counts as clinical evidence for software, how MDCG 2020-1 shapes the methodology, and where software teams get into trouble.
State of the Art in Clinical Evaluation: What It Means and How to Use It
What "state of the art" means in the context of MDR clinical evaluation, how it frames your benefit-risk analysis, and why getting this right matters for Class IIb and III devices.
Clinical Literature Search Methodology for Medical Device CERs
How to design and document a defensible literature search for your CER — database selection, search string construction, inclusion/exclusion criteria, PRISMA documentation, and the most common gaps that Notified Bodies flag.
How to Structure Your Clinical Evaluation Report Under EU MDR
A practical walkthrough of the CER structure required under Annex XIV — what goes in each section, what reviewers look for, and where most teams go wrong.
Clinical Equivalence Under EU MDR: What the Criteria Actually Require
What equivalence means under MDR, how the three criteria work in practice, and why the route that worked under MDD is much harder now.
Reading MDCG 2020-5: The Clinical Evaluation Guidance That Auditors Use
A practical walkthrough of MDCG 2020-5 — what it establishes, which sections matter most for practitioners, and how auditors apply it in practice.
PMCF Plan and Evaluation Report: What MDR Requires and How to Deliver It
What your PMCF plan needs to contain, how the PMCF evaluation report differs from the CER, and what happens when PMCF data changes your benefit-risk picture.
Clinical Evaluation Under EU MDR: What It Is and Why It Matters
A practical orientation to clinical evaluation under EU MDR — what it involves, what regulators expect, and how it connects to your technical documentation.
Clinical Investigations Under EU MDR: When You Need One and How to Plan It
When a clinical investigation is required under Article 62 and Annex XV, what the protocol needs to cover, how the ethics and competent authority approval process works, and what teams most often get wrong.
Critically Appraising Clinical Literature and Weighing Evidence for Your CER
How to move from a completed literature search to a defensible appraisal — assessing study quality, identifying bias, weighing evidence by type and relevance, and building a coherent evidence base for your CER conclusions.
Defining Clinical Benefit Under MDR: What It Is, How to Scope It, and How It Drives Benefit-Risk
What counts as clinical benefit under MDR, how to define and scope it in your CER, and how it connects to the benefit-risk assessment in Annex XIV and the GSPRs.
Clinical evaluation is one of the heaviest ongoing obligations under MDR, and the one that most frequently catches manufacturers off guard. Article 61 and Annex XIV set the framework, but understanding what they require in practice is a different matter. This category covers how clinical evidence is built, maintained, and used to support conformity — from the initial literature review through to PMCF reporting.
One thing that surprises many teams is that clinical evaluation is not a one-time exercise done before CE marking. MDR explicitly requires it to be kept current, which means your CER is a living document tied to your PMS system. If your post-market data is generating new signals — adverse events, complaints, literature updates — your CER needs to reflect that. Falling behind on this is one of the most common findings in Notified Body audits.
The equivalence pathway is where a lot of teams run into trouble. Under MDR, equivalence is considerably narrower than it was under MDD. To claim equivalence, you need sufficient clinical data from an equivalent device and — for Class III and implantable devices — a formal contract with the device's manufacturer to access their technical documentation. Many manufacturers who relied on equivalence under MDD no longer meet this bar. If this applies to your device, it is worth working out early, because the alternatives (clinical investigations, more extensive literature evidence) take significant time to build.
MDCG has published a series of guidance documents on clinical evaluation that are worth treating as near-regulatory in practice: MDCG 2020-5 (clinical evaluation), MDCG 2020-6 (equivalence), MDCG 2020-13 (PMCF), and MDCG 2022-2 (clinical investigations). These documents guide how Notified Bodies interpret the regulation, and they have been updated as questions emerged post-transition. Using them as a checklist alongside Annex XIV saves rework.
The resources in this category walk through CER structure, how to handle equivalence decisions, what goes into a PMCF plan and PMCF evaluation report, and how to align your clinical evaluation with the GSPR traceability in Annex I. Whether you're building a CER from scratch or reviewing what you have, start with the scope and methodology sections — that's where most of the gaps are found.
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The content on this page may be partially assisted by Artificial Intelligence (AI) to improve readability and ensure clarity.
While our team audits this content, please be aware:
- Accuracy: AI-assisted interpretations may contain nuances that differ from official MDCG guidance.
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