What Is Clinical Evaluation Under MDR? The Foundation
Clinical evaluation is the ongoing process of generating, collecting, and assessing clinical data on safety and performance. Here is what MDR Article 61 actually requires.
Category
Clinical Evaluation & Investigations
51 in-depth guides in this cluster
MDR Article 61: Clinical Evaluation Requirements Decoded for Startups
MDR Article 61 is the heart of clinical evaluation. Here is the article decoded paragraph by paragraph, with what each requirement actually means for startups.
Clinical Evaluation vs. Clinical Investigation: Understanding the Difference
Clinical evaluation is the ongoing process. Clinical investigation is a specific study. Conflating them wastes months. Here is the distinction every MedTech founder must understand.
The Clinical Evaluation Process Under MDR: A Step-by-Step Guide for Startups
The MDR clinical evaluation process runs from CEP through CER to PMCF in a defined sequence. Here is the step-by-step guide for startups.
MDR Annex XIV Part A: Clinical Evaluation Requirements
MDR Annex XIV Part A sets out the exact clinical evaluation process. Here is what each section requires — scope, data identification, appraisal, and analysis.
How to Write a Clinical Evaluation Plan (CEP) Under MDR
The CEP is the first document in your MDR clinical evaluation. Here is what it must contain, section by section, with the Annex XIV Part A references.
The Clinical Evaluation Report (CER) Under MDR: Structure and Common Mistakes
The CER is the central clinical document in the technical file. Here is the structure, the mandatory content, and the mistakes that trigger nonconformities.
How to Conduct a Systematic Literature Review for Clinical Evaluation
A systematic literature review is the backbone of most MedTech clinical evaluations. Here is how to scope, execute, and document it so the Notified Body accepts it.
Appraisal of Clinical Data Under MDR: How to Assess Data Quality
Appraising clinical data means grading each source for relevance and methodological quality. Here is how to do it under MDR in a way auditors accept.
Equivalence Under MDR: Demonstrating a Predicate Device
MDR equivalence requires demonstration across technical, biological, and clinical characteristics. Here is what MDCG 2020-5 demands and why most claims fail.
The Three Pillars of Equivalence: Technical, Biological, Clinical
MDR equivalence requires demonstration across technical, biological, and clinical characteristics — all three, not one or two. Here is how each pillar is defined and tested.
Why Equivalence Claims Are Harder Under MDR Than MDD — And What Startups Can Do
Equivalence claims are stricter under MDR than under MDD. Here is what changed, why it changed, and how startups should adapt their clinical evaluation strategy.
When You Cannot Claim Equivalence: Generating Your Own Clinical Data
If equivalence fails, you have to generate your own clinical data. Here is how to recognise that moment and plan the investigation that follows.
Clinical Data Sources Under MDR: Literature, Equivalence, Investigation
MDR recognises three main sources of clinical data: literature, equivalence, and clinical investigations. Here is how to choose and combine them.
MEDDEV 2.7/1 Rev 4 Under MDR: Is It Still Relevant in 2026?
MEDDEV 2.7/1 Rev 4 is legacy MDD guidance. Is it still useful under MDR in 2026? Here is the honest answer with concrete examples of what still applies.
MDCG Guidance on Clinical Evaluation: What Startups Need to Know
MDCG has published key clinical evaluation guidance documents that clarify MDR Article 61. Here are the main MDCG documents for startups and how to apply them.
Sufficient Clinical Evidence for Class I Devices: What Is Actually Required?
Class I devices still need clinical evaluation under MDR Article 61. Here is what counts as sufficient evidence — and the story of how one company saved EUR 400-500K.
Sufficient Clinical Evidence for Class IIa Devices: Practical Examples
Class IIa devices need more clinical evidence than Class I, but not as much as IIb or III. Here is the proportionate evidence bar with concrete examples.
Sufficient Clinical Evidence for Class IIb and III Devices: The Higher Bar
Class IIb and Class III devices face a higher clinical evidence bar under MDR. Here is what proportionate evidence looks like at the top end.
Clinical Evaluation of Software as a Medical Device: The Unique Challenges
Clinical evaluation for SaMD has the same MDR Article 61 backbone but unique data sources and validation methods. Here is what to know.
Clinical Evaluation for AI/ML Devices: How to Handle Continuously Learning Algorithms
Continuously learning AI complicates clinical evaluation. Here is how to scope the CE for adaptive algorithms under MDR Article 61.
What Is a Clinical Investigation Under MDR? When Your Startup Needs to Run a Study
A clinical investigation under MDR is a formal study on human subjects. Here is when you need one, what the MDR requires, and when you can avoid one.
MDR Chapter VI: Clinical Investigations — The Full Regulatory Framework
MDR Chapter VI (Articles 62-82) is the full regulatory framework for clinical investigations. Here is the chapter walkthrough for startup sponsors.
How to Design a Clinical Investigation for a MedTech Startup
Designing a startup clinical investigation under MDR means scoping to answer the specific clinical question with the smallest viable study. Here is the design framework.
Writing a Clinical Investigation Plan (CIP) Under MDR Article 62
The CIP is the blueprint for your MDR clinical investigation. Here is what Article 62(4) and Annex XV require in it — section by section.
Ethical Approval for Clinical Investigations: Ethics Committee Requirements Under MDR
MDR clinical investigations need ethics committee approval. Here is what the committee checks and how to prepare the submission.
Informed Consent Under MDR Article 63: Requirements for Clinical Investigation Subjects
MDR Article 63 sets the informed consent rules for clinical investigations. Here is what the consent form must contain and how to draft it.
The Sponsor's Obligations in Clinical Investigations Under MDR Article 62(4)
MDR Article 62(4) sets out what the sponsor of a clinical investigation must do. Here is the obligations list and how it lands on a startup sponsor.
How to Apply for Clinical Investigation Approval with Your National Competent Authority
MDR clinical investigation approval application: Annex XV dossier contents, Article 70 timelines, and multi-state coordination for startup sponsors.
MDR Article 62(4)(g): Financial Compensation and Insurance for Clinical Investigations
MDR Article 62(4)(g) requires sponsors to arrange financial compensation and insurance for clinical investigation subjects. Here is what that means in practice.
Adverse Event Reporting During Clinical Investigations Under MDR Article 80
MDR Article 80 defines the adverse event reporting obligations during clinical investigations. Here is the timeline, the reportability, and how to operate it.
The Clinical Investigation Report: What to Include After Your Study Completes
MDR Article 77 requires a clinical investigation report after the study completes. Here is what to include and the publication obligation.
First-in-Human Studies Under MDR: Extra Requirements and Precautions
A first-in-human study under MDR demands extra pre-clinical evidence, sponsor rigour, and ethics oversight. Here is what Article 62 actually requires.
How to Run a Lean Clinical Investigation as a Startup with Limited Budget
A MedTech clinical investigation does not have to cost millions. Here is how to scope a lean, GCP-compliant study that satisfies MDR without burning your runway.
Clinical Investigations for Software: Do You Need a Clinical Study for Your SaMD?
Software medical devices sometimes need clinical investigations and sometimes don't. Here is the decision framework for SaMD startups under MDR.
Alternatives to Clinical Investigations: Performance Studies and Usability Data
Clinical investigations are not the only MDR evidence source. Alternatives: performance studies, usability data, registries, retrospective analyses.
Bench Testing and Non-Clinical Evidence: How It Supports Your CER
Bench testing and non-clinical evidence can carry large parts of an MDR CER. When Article 61(10) applies and how to stack the pre-clinical package.
Real-World Evidence Under MDR: Strengthening Clinical Evaluation With Post-Market Data
Real-world evidence under MDR feeds clinical evaluation through PMCF, registries, surveys, and complaints. Here is how to turn post-market data into a defensible CER.
The Clinical Evaluation Consultation Procedure for Class III and Implantable Devices
CECP under MDR Article 54 sends Class III implantables and certain Class IIb actives to an EU expert panel. Scope, timeline, and CER readiness playbook.
How to Update Your Clinical Evaluation Report: Lifecycle Requirements Under MDR
The CER is not a one-time document. MDR requires periodic updates driven by PMS and PMCF data. Here is the lifecycle cadence and what triggers an update.
Clinical Evaluation Timelines for Startups: Realistic Planning from Day One
Clinical evaluation under MDR takes longer than founders plan. Here are realistic timelines from CEP to CER and the things that break them.
Outsourcing Clinical Evaluation: When to Hire a CRO vs. Doing It In-House
When to hire a CRO for clinical evaluation vs. doing it in-house. Decision matrix, RFP playbook, and what MDR Article 10 still leaves on your desk.
The Biggest Clinical Evaluation Mistakes Startups Make Under MDR
The ten clinical evaluation mistakes that appear in almost every MDR startup audit — each anchored to the article they violate and the fix.
Clinical Evaluation for Combination Products: Drug-Device Requirements
Clinical evaluation for drug-device and biologic-device combination products under MDR: CER scope, ancillary substance data, and the EMA consultation route.
How to Handle Missing Clinical Data Under MDR: Gap Analysis for Startups
A GSPR-by-GSPR gap analysis method for MDR startups whose clinical evaluation comes up short — with four options to close each gap.
Literature Search Protocols: Building a Reproducible Search Strategy
A reproducible literature search protocol is a CER prerequisite. Here is how to write one that an auditor can verify and a successor can re-run.
State of the Art in Clinical Evaluation: Benefit-Risk Acceptability
How to establish state of the art in an MDR clinical evaluation, benchmark alternatives, and demonstrate benefit-risk acceptability under Article 61.
Clinical Evaluation of Legacy Devices Transitioning from MDD to MDR
Legacy devices transitioning from MDD to MDR need their clinical evaluations upgraded to MDR Article 61. Here is the gap analysis and how to close it.
How Notified Bodies Review Clinical Evaluation Reports: The Auditor's Checklist
When a Notified Body reviews a CER, they apply a structured checklist. Here is what they check and how to anticipate the review.
Building a Clinical Evidence Strategy for Your Startup's Entire Product Portfolio
Plan one clinical evidence strategy across every SKU in your portfolio. Shared pools, family CERs, and PMCF that covers the whole product line.
Pre-Clinical Trial Readiness Under MDR: The 600–3,000 Test Reality
Before a clinical investigation under MDR Article 62, Annex XV requires a full pre-clinical evidence stack. Here is what that actually looks like.