MEDDEV 2.7/1

This topic is part of the SG Systems Global medical device lifecycle, clinical evidence & regulatory compliance glossary.

Updated December 2025 • Medical Device Regulations, EU MDR 2017/745, CE Marking, Medical Device Life Cycle, Medical Device Classes, Medical Device Clinical Trials, ISO 13485, ISO 14971 Risk Management, Medical Device QMS, Design History File (DHF), Verification & Validation (V&V), Postmarket Surveillance, Customer Complaint Handling, Change Control, CAPA, Data Integrity, Audit Trail
• EU legacy directives, EU MDR transition programmes, clinical evaluation (CER), literature review, equivalence, PMCF and lifecycle evidence

MEDDEV 2.7/1 is the EU “how to do it” playbook that shaped modern clinical evaluation for medical devices. It is one of the most cited and most misunderstood guidance documents in European device compliance because it sits in a weird place: it is not a regulation, but it has historically been treated like one. Manufacturers use it to structure a Clinical Evaluation and write a Clinical Evaluation Report (CER). Notified Bodies use it to judge whether your clinical story is real, complete, and defensible.

In practical terms, MEDDEV 2.7/1 defines what “clinical evidence” is supposed to look like when you are trying to demonstrate that your device performs as intended and that the benefits outweigh the risks. It pushes teams away from marketing claims and cherry-picked papers and forces a disciplined, repeatable approach: define the question, identify data sources, appraise quality, analyse relevance, and update over time.

Even though the EU MDR is now the legal foundation for clinical evaluation, MEDDEV 2.7/1 is still embedded in the industry’s habits, templates, audit checklists, and “how we do CERs.” If you build your clinical evaluation programme without understanding MEDDEV 2.7/1, you are likely to repeat the same avoidable mistakes that keep Notified Bodies busy: weak literature search methodology, vague equivalence arguments, stale data, and clinical claims that outpace evidence.

“If your clinical evaluation is a document you ‘finish’ before certification, you missed the point. MEDDEV 2.7/1 treats clinical evaluation as a living lifecycle control — the same way a risk file should be living.”

1) What MEDDEV 2.7/1 Actually Is

MEDDEV stands for “Medical Device Guidance Documents.” These documents were published to support consistent implementation of the old EU medical device directives. Within that series, MEDDEV 2.7/1 is specifically focused on clinical evaluation — the process of collecting and assessing clinical data to demonstrate safety and performance for the intended purpose.

The most commonly referenced version is MEDDEV 2.7/1 Rev. 4, which significantly tightened expectations around:

• the structure and repeatability of the clinical evaluation process,
• how to run and document literature searches,
• how to appraise data quality (not just list papers),
• how to justify equivalence (and where equivalence is weak), and
• how often clinical evaluation should be updated, based on risk and field experience.

It is important to treat MEDDEV 2.7/1 for what it is: a methodology guide. It doesn’t “approve” devices. It defines what good clinical evaluation looks like and, by extension, what poor clinical evaluation looks like. That matters because clinical evaluation is not a side activity — it is part of the evidence chain needed for CE Marking.

2) Where MEDDEV 2.7/1 Sits in the EU Compliance Ecosystem

To understand why MEDDEV 2.7/1 is so persistent, you have to understand how EU device compliance works as a system.

At the top, the law today is the EU MDR 2017/745. Under the old regime, the law was the directives. MEDDEV guidance sat underneath those laws and described how stakeholders could interpret and implement requirements in a practical, consistent way.

In the real world, clinical evaluation is assessed in multiple contexts:

• Conformity assessment: your Notified Body assesses whether your technical documentation and clinical evidence support conformity for CE marking.
• Surveillance audits: your Notified Body expects clinical evaluation to be maintained as part of lifecycle compliance.
• Change control: design or manufacturing changes can trigger a clinical impact assessment, and the CER often needs updates (see Change Control).
• Postmarket: complaints, vigilance and trend signals can force clinical re-evaluation (see Postmarket Surveillance).

So even if you are “done” writing a CER, you are not done running clinical evaluation. That’s the fundamental shift MEDDEV 2.7/1 helped normalise: clinical evaluation is a lifecycle process, not a submission ritual.

3) Clinical Evaluation Is a Lifecycle Control, Not a One-Time Report

MEDDEV 2.7/1 frames clinical evaluation as a continuous activity across the medical device lifecycle. That is consistent with how regulators think: the real world will always generate new data that can challenge your premarket assumptions.

In a mature programme, clinical evaluation is connected to:

• Design controls: clinical claims must be traceable to requirements and validated outcomes (see DHF and V&V).
• Risk management: clinical data supports benefit–risk conclusions and confirms risk controls are effective (see ISO 14971).
• Labelling: warnings, contraindications and IFU content should align with the clinical evidence base.
• Postmarket surveillance: field data validates whether the benefit–risk profile holds in routine use (see PMS).
• CAPA: clinical or safety signals that reveal systemic issues should feed corrective and preventive action (see CAPA).

If your CER is disconnected from these systems, you will struggle under MDR-era Notified Body scrutiny. The expectation is not just “you wrote a report.” The expectation is “your organisation continuously controls clinical risk using evidence.”

4) The MEDDEV 2.7/1 Process Model: Plan → Identify → Appraise → Analyse → Conclude

MEDDEV 2.7/1 is valuable because it describes a repeatable process. You can think of it as a quality-system approach applied to clinical evidence.

A practical MEDDEV-style workflow looks like this:

• Plan: define device, intended purpose, target population, clinical claims, endpoints, and the strategy for gathering data.
• Identify: collect clinical data sources (literature, investigations, clinical experience, postmarket data).
• Appraise: assess methodological quality and relevance (bias, study design, applicability).
• Analyse: synthesise data to answer safety and performance questions; evaluate benefit–risk.
• Conclude: state whether evidence is sufficient, identify gaps, and define updates/PMCF needs.

This is exactly the kind of structure auditors like because it supports traceability: you can show how you went from a clinical question to a conclusion using controlled methods. It also exposes weak evaluations quickly: if you can’t explain your appraisal criteria or your literature search logic, your conclusions become opinion.

Done well, the process also scales. You can apply it to a single device, a device family, or iterative product versions — as long as your boundaries and assumptions are documented and controlled.

5) Key Deliverables: Clinical Evaluation Plan and CER (and Why Document Control Matters)

MEDDEV 2.7/1 pushes manufacturers toward two core deliverables:

• Clinical Evaluation Plan (CEP): what you intend to evaluate, what data you will use, how you will search and appraise, and how you will decide sufficiency.
• Clinical Evaluation Report (CER): what you found, how you judged it, what it means for safety/performance, and what gaps or follow-up remain.

Even if your organisation uses different names or templates, the logic remains: a plan prevents “evidence shopping,” and a report provides the audited conclusion.

This is where your QMS either helps you or hurts you. If the CER is uncontrolled, inconsistently updated, or not aligned with design/risk outputs, you create regulatory exposure. Your CER should be treated like a controlled quality record: versioned, reviewed, approved, and linked to change control. That’s basic compliance hygiene under a medical device QMS and ISO 13485.

In other words: if you wouldn’t manage your design inputs in a shared Google Doc, don’t manage your CER that way either.

6) What Counts as “Clinical Data” Under MEDDEV 2.7/1

One of the biggest contributions of MEDDEV 2.7/1 is that it broadens what teams consider “clinical data.” It’s not only randomised controlled trials. Clinical evaluation is typically built from a mix of sources, such as:

• Clinical investigations: prospective clinical studies of the device (often necessary for novel or high-risk devices) — closely connected to medical device clinical trials.
• Scientific literature: published studies relevant to the device, equivalent devices, or the state of the art.
• Clinical experience: real-world use data, registries, observational studies, and outcomes collected after marketing.
• Postmarket signals: complaints, vigilance reports, trend data, and field actions (see Complaint Handling and PMS).

The point is not to gather “more” data. The point is to gather the right data to answer the right questions. A low-risk, well-established technology may rely heavily on literature and experience. A novel implant or life-sustaining device should expect a much heavier burden and a stronger justification for why direct clinical investigation is or isn’t needed.

MEDDEV’s approach is fundamentally risk-based, which aligns with modern regulatory thinking: evidence depth should match device risk, novelty, and intended purpose.

7) Literature Search Discipline: MEDDEV’s Quiet “Hard Mode” Requirement

Many CERs fail on literature search methodology. MEDDEV 2.7/1 Rev 4 made it hard to bluff: you are expected to show a structured search strategy, not “we found some papers.”

A defensible MEDDEV-style literature approach includes:

• Search question(s): what you are trying to establish about safety, performance, and state of the art.
• Search strategy: databases used, keywords, controlled vocabulary, time range, language, inclusion/exclusion criteria.
• Screening and selection: how records were filtered, including documented reasons for exclusion.
• Quality appraisal: how you judged study design quality, bias risk, relevance to intended use, and comparability of populations/endpoints.

Regulatory reviewers are looking for the same failure pattern over and over: the manufacturer selects studies that support marketing claims and ignores inconvenient evidence. MEDDEV’s answer is process transparency: if your search and appraisal are structured, reviewers can trust you didn’t manipulate the conclusion.

Practically, this also reduces internal conflict. When R&D and marketing push for aggressive claims, a controlled literature process forces the organisation to confront whether the evidence actually supports those claims.

8) Equivalence Under MEDDEV 2.7/1: Useful Concept, Dangerous Shortcut

Equivalence is one of the most controversial parts of clinical evaluation. MEDDEV 2.7/1 allows manufacturers, in some cases, to use clinical data from an equivalent device to support their own device’s clinical evaluation. In theory, this prevents duplicated studies and speeds access for devices that are truly comparable.

In practice, equivalence becomes a temptation: “We don’t want to run a study, so we’ll call something equivalent.” That is exactly why Notified Bodies scrutinise equivalence claims aggressively.

A credible equivalence argument typically requires demonstrating similarity across multiple dimensions, such as:

• Technical characteristics: design, specifications, performance, materials, energy source, software logic.
• Biological characteristics: contact materials, tissue interactions, biocompatibility-relevant differences.
• Clinical characteristics: intended purpose, indications, user population, site of application, clinical performance endpoints.

MEDDEV’s message is simple: equivalence is not “close enough.” It is “so similar that clinical outcomes are transferable.” If you can’t defend that, your CER becomes a story built on borrowed data — and the first time reality disagrees, you own the consequences.

9) Why Equivalence Got Harder Under EU MDR

Even though MEDDEV 2.7/1 sits in the legacy directives era, its equivalence logic intersects with MDR-era expectations. Under the EU MDR, equivalence is treated more strictly — especially for higher-risk devices — because regulators learned how often “equivalence” was used to avoid generating real clinical evidence.

The practical implications:

• Access to data matters: if you rely on an equivalent device’s data, you often need legitimate access to the underlying technical and clinical documentation (not just public brochures).
• Notified Body scrutiny increases with risk: for Class III and implants, the bar for equivalence is high and easy equivalence narratives collapse fast.
• Clinical evidence gaps become visible: if equivalence is weak, the “gap” usually means PMCF or a clinical investigation.

Bottom line: you can still use MEDDEV 2.7/1’s structured approach to evaluate equivalence, but you should expect MDR-era reviewers to treat equivalence as an exception, not a default pathway. If you choose equivalence, document it like you expect it to be challenged — because it will be.

10) When Clinical Investigation Becomes the Only Defensible Option

MEDDEV 2.7/1 is often used to answer a core question: Do we need a clinical investigation? The honest answer is: sometimes you can justify not doing one, and sometimes you can’t.

Clinical investigation pressure increases when:

• the device is novel or introduces new technology,
• the device is higher risk (implant, life-supporting, life-sustaining),
• there are meaningful differences from existing devices,
• the intended purpose expands into new populations or indications, or
• postmarket data suggests safety/performance uncertainty.

Even for established technologies, clinical investigation may be needed when the clinical claims are ambitious. There is a direct link between what you want to claim and what evidence you must produce. A conservative claim might be supported by literature and experience. A strong claim usually demands stronger, direct evidence.

This is why clinical evaluation must be linked to design and risk management. If your design outputs and risk file imply serious hazards, but your clinical evidence is thin, the inconsistency is obvious to reviewers.

11) Updating Clinical Evaluation: Frequency, Triggers, and the “Living CER” Reality

MEDDEV 2.7/1 Rev 4 emphasises that clinical evaluation must be actively updated with a frequency that is justified based on risk, novelty, and clinical experience.

In practice, there are two update drivers:

• Time-based updates: periodic refresh based on a defined schedule (often aligned with Notified Body surveillance cycles).
• Event-based updates: triggered by changes or signals — new complaints trends, field safety actions, design changes, new published evidence, or new state-of-the-art expectations.

The most dangerous trap is treating updates as “admin work.” Updates are where you discover whether your original clinical conclusions still hold. If new literature shows a risk you didn’t account for, your CER must reflect that and your organisation must decide what to do: label updates, training, design changes, or CAPA.

Operationally, updating clinical evaluation should be integrated with:

• Postmarket Surveillance (signals and trends),
• Complaint Handling (case investigations and reportability),
• Change Control (clinical impact assessments), and
• CAPA (systemic corrective actions).

This is how “living CER” becomes real: not by rewriting paragraphs, but by connecting clinical evaluation to the operational systems that detect and correct risk.

12) The Notified Body View: What MEDDEV Trained Reviewers to Look For

Notified Bodies have seen thousands of CERs. MEDDEV 2.7/1 pushed them toward consistent review questions, such as:

• Scope clarity: is the intended purpose clearly defined, and does the evidence match that purpose?
• Evidence relevance: are the studies actually about comparable devices, populations, and endpoints?
• Quality appraisal: did the manufacturer critically appraise data quality, or just list citations?
• Benefit–risk logic: are benefits and risks evaluated realistically, including known complications and failure modes?
• State of the art: does the evaluation position the device in context of current clinical practice and alternatives?
• Lifecycle updating: is there evidence of active updating, not a static “one-time” report?

If you want to predict whether a Notified Body will accept your clinical evaluation, ask a brutal internal question: If someone disagreed with our conclusion, could they follow our method and understand why we concluded what we concluded? If the answer is no, the CER is not audit-ready.

Also note: Notified Bodies often evaluate clinical evidence as part of a broader QMS assessment. If your clinical evaluation says “risk is controlled,” but your complaint trends show recurring harm and your CAPA system is weak, you have an integrity gap. Reviewers don’t need to “catch you.” They just need to notice the inconsistency.

13) MEDDEV vs MDR vs MDCG: How to Use MEDDEV Without Treating It as Law

Today, the legal basis for EU device compliance is the EU MDR, supported by MDCG guidance documents. MEDDEV 2.7/1 remains influential, but it is not the regulation.

A practical way to handle this is:

• Use MDR for requirements: define what you must achieve (clinical evaluation, clinical evidence, PMCF expectations, PMS outputs).
• Use MEDDEV for method: apply a structured evaluation methodology (plan, search, appraise, analyse, conclude).
• Use MDCG guidance for current interpretation: especially where MDR-era expectations tighten or clarify topics like equivalence and clinical evidence for legacy devices.

This approach prevents a common failure mode: teams quoting MEDDEV language to justify weaker clinical evidence than MDR expectations. If there is any conflict between MEDDEV-era assumptions and MDR-era requirements, MDR wins — and reviewers will expect your rationale to follow the law.

In other words, MEDDEV is a tool. It is not a shield.

14) Common CER Failure Modes MEDDEV Was Designed to Prevent

Most CER findings and rework cycles are not “complex science problems.” They are process discipline problems. MEDDEV 2.7/1 is essentially a catalogue of how not to fool yourself.

Common failure modes include:

• Claims drift: marketing claims expand, but clinical evidence doesn’t (or can’t) keep up.
• Weak literature methodology: no structured search strategy, unclear selection, no exclusion rationale.
• No critical appraisal: the CER lists papers but never evaluates study quality or bias.
• Equivalence as wishful thinking: “similar enough” language without technical/clinical justification.
• Ignoring negative evidence: studies showing complications or failures are downplayed or excluded without justification.
• No state-of-the-art analysis: the device is evaluated in isolation, not against modern alternatives and practice.
• Stale clinical evaluation: CER not updated despite new field data or literature.

These are not “paperwork issues.” They are patient-safety issues disguised as documentation. If you can’t demonstrate that your device is safe and performs as intended using controlled evidence methods, you don’t have control — and regulators have no reason to trust you.

15) Practical Implementation Tips: Making MEDDEV 2.7/1 Work for You

If you use MEDDEV 2.7/1 as a living operational framework, it becomes an advantage rather than a burden. Practical tips that consistently reduce Notified Body friction:

• Start with intended purpose boundaries. Define what the device is and is not intended to do. Scope creep kills CERs.
• Build an evidence map. Link each clinical claim and risk control to specific evidence sources and appraisals.
• Make literature surveillance routine. Don’t “search once.” Put clinical literature review on a schedule aligned to risk.
• Use consistent appraisal criteria. Define how you judge quality across study types so appraisal doesn’t become subjective.
• Integrate PMS and complaints early. Field data is not an appendix; it is part of the clinical story (see PMS and complaints).
• Control updates through change control. Changes that could impact clinical performance must trigger impact assessment and CER review (see Change Control).
• Write like you expect challenge. Use clear logic, show your method, show your exclusions, show your gaps.

The goal is not to produce a “perfect” CER. The goal is to produce a CER that is defensible, reproducible, and clearly tied to a QMS that continuously manages risk.

16) Data Integrity and Auditability: Why MEDDEV Work Breaks in Spreadsheets

MEDDEV-style clinical evaluation is method-heavy. That creates an evidence management problem: searches, screening logs, appraisal records, updates, approvals, and change rationales must be trustworthy over years.

This is where data integrity and audit trails stop being “IT topics” and become regulatory survival topics.

If your clinical evaluation evidence is scattered across personal drives, email threads, and uncontrolled spreadsheets, you create predictable failure points:

• you can’t prove which version was approved when,
• you can’t prove who changed conclusions and why,
• you can’t reliably reproduce your literature search, and
• you can’t demonstrate controlled updating aligned to PMS and change control.

For devices with long lifecycles, the best compliance investment is often not “more writing.” It’s building controlled systems that keep your clinical evaluation evidence consistent, traceable, and reviewable without heroics.

17) What MEDDEV 2.7/1 Means for V5

On the V5 platform, MEDDEV-style clinical evaluation becomes easier to defend because the supporting evidence is connected and controlled. The practical advantage is not cosmetic compliance. It’s speed and integrity: when a Notified Body asks “show me the link between clinical claims, risk controls, V&V, and postmarket signals,” you don’t have to assemble a narrative from disconnected files.

• V5 QMS
  • Supports controlled documentation, reviews, approvals, and training aligned to ISO 13485.
  • Connects clinical evaluation updates to change control, CAPA, and complaint handling.
  • Enforces auditability through controlled workflows and data integrity expectations.
• V5 MES
  • Strengthens the “real-world” evidence loop by providing traceable manufacturing history when field performance questions arise.
  • Helps connect product changes to clinical impact assessments with better device history context.
• V5 WMS
  • Improves traceability for field actions and postmarket follow-up by linking distributed products to customers and markets.
  • Supports faster, narrower investigations when complaints or vigilance signals trigger clinical re-evaluation.

Net effect: MEDDEV 2.7/1 becomes less about “writing a better document” and more about proving a controlled evidence system. That is what regulators and Notified Bodies are actually trying to assess.

FAQ

Q1. Is MEDDEV 2.7/1 legally binding under the EU MDR?
No. The EU MDR is the law. MEDDEV 2.7/1 is guidance that remains useful as a method framework, but it does not override MDR requirements.

Q2. What is MEDDEV 2.7/1 mainly used for?
It is mainly used to structure clinical evaluation work and to write a Clinical Evaluation Report (CER): defining the clinical questions, running literature searches, appraising data quality, analysing relevance to intended purpose, and concluding on safety/performance and benefit–risk.

Q3. Does MEDDEV 2.7/1 require clinical trials for every device?
No. It supports a risk-based evidence strategy. Some devices can be supported by literature and clinical experience. Others — especially novel or higher-risk devices — may require clinical investigation. The key is that your rationale must be defensible and aligned to risk and intended purpose.

Q4. Why do Notified Bodies reject CERs even when there are many citations?
Because volume of citations is not evidence quality. The common failures are weak search methodology, lack of critical appraisal, poor relevance to intended use, and unsupported equivalence arguments. MEDDEV expects transparent methods and defensible conclusions, not “a bibliography.”

Q5. What’s the fastest way to improve a weak MEDDEV-style clinical evaluation?
Fix the method first: define intended purpose boundaries, implement a structured literature search and selection process, add consistent quality appraisal criteria, and connect the CER to risk management and postmarket data. If those foundations are solid, the report becomes easier to defend and easier to update.

Related Reading
• EU & Lifecycle: Medical Device Regulations | EU MDR 2017/745 | CE Marking | Medical Device Life Cycle
• Clinical Evidence: Medical Device Clinical Trials | Verification & Validation (V&V) | Postmarket Surveillance
• Quality & Risk: Medical Device QMS | ISO 13485 | ISO 14971 Risk Management | Change Control | CAPA
• Data & Auditability: Data Integrity | Audit Trail
• Official Reference (EU): MEDDEV 2.7/1 Rev. 4 – Clinical evaluation: a guide for manufacturers and notified bodies