Clinical Evaluation under the MDR: Article 61, Annex XIV, the Plan and the Clinical Evaluation Report

The duty falls on every manufacturer. Where a notified body takes part in the conformity assessment, it records its findings in a clinical evaluation assessment report, and manufacturers of implantable and class III devices face two extra rules: clinical investigations unless an exemption applies, and an update of the PMCF evaluation report and, if indicated, the SSCP at least once a year.

This page sets out the four MDR definitions, the plan, the method, the report and its assessment, the exemptions with the list as replaced in July 2026, the non-clinical route, updates, orphan devices and the MDCG guidance.

What Is Clinical Evaluation under the MDR?

MDR Article 2(44) defines clinical evaluation as a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. The word "continuously" carries weight: the evaluation does not end with a first report, because post-market data keep feeding it.

MDR Article 61(1) requires a clinical evaluation for all devices, whatever their class. The MDR is a regulation, directly applicable in every member state without national transposition; it entered into force on 25 May 2017 (MDR Article 123(1)) and has applied since 26 May 2021 (MDR Article 123(2) as amended by Regulation (EU) 2020/561). For medical devices, clinical evaluation is one of the core obligations of the EU MDR and IVDR framework.

In practice, a clinical evaluation consists of a plan, the clinical data, a critical evaluation of those data, a report and continuous updates from the market. In vitro diagnostic devices follow a different process, performance evaluation, covered at the end of this page.

Clinical Data, Clinical Evidence and Clinical Benefit

MDR Article 2(48) names four sources of clinical data: clinical investigations of the device; clinical investigations or other studies in the scientific literature of a device whose equivalence can be demonstrated; peer-reviewed reports on other clinical experience of the device or an equivalent device; and clinically relevant post-market surveillance information, in particular from PMCF. Two of the four sources therefore admit data from an equivalent device, provided the equivalence can be demonstrated.

Clinical evidence is defined in MDR Article 2(51) as "clinical data and clinical evaluation results of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s)". Clinical benefit is defined in MDR Article 2(53) as the "positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health". The two definitions connect: clinical evidence is judged against the intended clinical benefit.

The Legal Basis: MDR Article 61 and Annex XIV Part A

MDR Article 61, paragraphs (1) to (13), sets the clinical evaluation duty, and MDR Annex XIV, titled "Clinical evaluation and post-market clinical follow-up", gives the method in Part A, Sections 1 to 4, and PMCF in Part B. Both texts are in the consolidated MDR on EUR-Lex. Article 61 holds the duty, the method, the rules for implants and class III devices, the exemptions and the update cycle; Annex XIV Part A holds the plan, the proportionality rule and, in Section 3, the equivalence test.

Two points complete the legal picture as of 6 November 2026. The Article 61(6)(b) list of devices exempt from clinical investigations has been replaced by a delegated regulation, set out in the section on the exemption list below. MDR Article 61(13) allows implementing acts, and none had been adopted as of that date. Article 61 opens Chapter VI of the EU MDR (Regulation (EU) 2017/745), which runs to Article 82.

Clinical Evaluation in Detail: Five Linked Topics

Five pages cover equivalence, evidence for devices certified under the Directives, post-market clinical follow-up, clinical investigations and the summary of safety and clinical performance. Each of them takes one part of Article 61 or Annex XIV further than this overview, as the table shows.

The Clinical Evaluation Plan

Before the evaluation starts, MDR Annex XIV Part A Section 1(a) requires the manufacturer to establish and update a clinical evaluation plan (CEP) with a set minimum content. The minimum content is listed below in the order of Section 1(a).

• General safety and performance requirements that need clinical data.
• Intended purpose of the device.
• Target groups, with indications and contra-indications.
• Intended clinical benefits, with outcome parameters.
• Methods for clinical safety, including residual risks and side-effects.
• Parameters for the acceptability of the benefit-risk ratio, based on the state of the art.
• Benefit-risk issues of components such as pharmaceuticals or tissues, and how they are addressed.
• Clinical development plan, from exploratory to pivotal investigations and PMCF, with milestones and acceptance criteria.

Notified bodies record the plan in section C of their clinical evaluation assessment report, next to the device and the common specifications and standards applied. Its first item links clinical evaluation to the rest of the conformity file: the plan names which of the general safety and performance requirements of Annex I need clinical data.

In the MDR sense, an evaluation plan is therefore the CEP: the document that fixes, before data are collected, which requirements need clinical data, which clinical benefits are claimed, how they are measured, and how benefit and risk will be judged against the state of the art. Because Section 1(a) asks the manufacturer to establish and update the plan, the plan is kept current as the evaluation progresses.

How the Evaluation Is Carried Out

MDR Article 61(3) sets the method: a critical evaluation of the relevant scientific literature, a critical evaluation of the results of all available clinical investigations, and a consideration of the alternative treatment options currently available. The three elements apply to every device. The two sections below explain where the data come from and how deep the evaluation has to go.

Literature, Study Results and Alternative Treatments

Literature counts for the device itself or for a device whose equivalence is demonstrated under Annex XIV Part A Section 3; the conditions for that are set out on the equivalence page listed above. Clinical investigations count with all their available results, not a selection of them. The consideration of alternative treatment options links the method to the benefit-risk parameters the plan sets on the basis of the state of the art.

Read together, Article 61 and Annex XIV give the evaluation a sequence of five stages, listed below.

1. Establish the clinical evaluation plan under Annex XIV Part A Section 1(a).
2. Identify clinical data from the four sources of MDR Article 2(48).
3. Evaluate the literature and the clinical investigation results critically, and consider alternative treatments (MDR Article 61(3)).
4. Document the evaluation and its conclusions in the clinical evaluation report.
5. Update the evaluation with PMCF and other post-market data.

Depth Proportionate to Device Risk and Claims

MDR Annex XIV Part A Section 2 makes the depth and extent of the clinical evaluation proportionate to the nature, classification, intended purpose, risks and claims of the device, and the evaluation covers both favourable and unfavourable data. Classification is one of the five factors named, and the class comes from the 22 rules of MDR Annex VIII.

The same logic runs through MDR Article 61(1): the manufacturer specifies and justifies the level of clinical evidence. A simple, well-known class I device and a novel class III implant therefore differ in the amount of evidence, not in the duty itself. For devices certified under the Directives, MDCG 2020-6 (April 2020) explains what the MDCG considers sufficient clinical evidence.

The Clinical Evaluation Report (CER)

The clinical evaluation report documents the clinical evaluation, and MDR Article 61(12) makes it part of the technical documentation under Annex II for every device except custom-made devices. The report carries the conclusions of the evaluation and the justifications Article 61 asks for in the exemption cases. Under MDR Annex XIV Part B Section 7, the PMCF evaluation report also becomes part of the clinical evaluation report.

Where the CER Sits and Who Reads It

MDR Annex II Section 6.1(c) and (d) list the clinical evaluation plan, the clinical evaluation report and the PMCF plan and evaluation report among the verification and validation documents. They sit next to the pre-clinical data of Section 6.1(b), such as biocompatibility, electrical safety and software verification, and the full structure is set out under MDR and IVDR technical documentation.

The notified body is the first reader of the CER, as the next section shows. For implantable and class III devices, the summary of safety and clinical performance (SSCP) required by MDR Article 32 summarises the clinical evaluation and the PMCF in a public document.

The Clinical Evaluation Assessment Report: MDCG 2020-13

MDCG 2020-13, published in July 2020 and current on the Commission's MDCG list as of 6 November 2026, is the template notified bodies use for their clinical evaluation assessment report (CEAR), and its 11 sections A to K show what an assessor records about a CER. The MDCG 2020-13 template is published on the Commission's health website. The table maps each section to the MDR provision this page explains.

Section letters from MDCG 2020-13 (July 2020), current as of 6 November 2026.

MDCG 2020-13 is a guidance template, and its legal weight is explained in the MDCG section further down. A manufacturer can read the 11 sections as a checklist of what the assessor will examine, from the literature search to the PMCF data, and organise the CER so that each section finds its evidence quickly. The bodies that do this work are described under notified bodies for the MDR and IVDR.

Implants and High-Risk Devices: New Clinical Data and the Exemptions

MDR Article 61(4) requires clinical investigations for implantable devices and class III devices, unless one of the exemptions of Article 61(4), (5) or (6) applies.

The duty attaches to the device being implantable or in class III. A class IIb device falls under Article 61(4) only where it is implantable; the general Article 61(1) duty covers every other class IIb device. How investigations are applied for and run (MDR Articles 62 to 82 and Annex XV) is covered on the clinical investigations page listed in the table above.

The Article 61(4), (5) and (6) Exemptions

Four routes avoid a new clinical investigation: a modification of the manufacturer's own marketed device where equivalence is demonstrated and endorsed by the notified body (Article 61(4)); reliance on another manufacturer's device under the conditions of Article 61(5); a device lawfully placed on the market under Directive 90/385/EEC or 93/42/EEC whose clinical evaluation rests on sufficient clinical data and complies with product-specific common specifications where available (Article 61(6)(a)); and the devices listed in Article 61(6)(b). The conditions of the Article 61(5) route are set out on the equivalence page.

Each exemption case is justified in the clinical evaluation report and in the notified body's clinical evaluation assessment report (MDR Article 61(7)). Manufacturers of class III devices and of class IIb devices covered by Article 54(1)(b) may consult an expert panel on their clinical development strategy before the clinical evaluation or investigation (MDR Article 61(2)). Class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product (MDR Annex VIII Rule 12) go through the clinical evaluation consultation procedure of MDR Article 54, and how the panels work is set out under expert panels under the MDR and IVDR.

The Exemption List as Replaced in July 2026

Commission Delegated Regulation (EU) 2026/1451, adopted on 20 March 2026 and published in OJ L, 2026/1451, 29.6.2026, has replaced the MDR Article 61(6)(b) list since 19 July 2026. The text of Delegated Regulation (EU) 2026/1451 keeps the 12 types of the original list (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) and adds new entries, such as cannulas, port catheters, introducers, dilators, dental implants, nails, anchors, spinal posterior fixations, bone substitutes, reusable surgical instruments, guidewires, pressure wires, pacing wires and leads, endovascular embolisation coils, shunts and internal defibrillation paddles.

Recital 2 names four criteria behind the entries: a common, simple and stable design; well-known safety, not associated with safety issues; well-known clinical performance, as standard of care with little evolution; and a long history on the Union market. Recital 5 adds that manufacturers must still plan, conduct and document a clinical evaluation under Article 61. A listed device is exempt from the clinical investigation, never from the clinical evaluation.

When Clinical Data Are Not Appropriate

Where demonstrating conformity on clinical data is not deemed appropriate, MDR Article 61(10) lets the manufacturer justify the non-clinical route from the risk management, the device-body interaction, the intended performance and the claims, but not for implantable or class III devices. Section J of the notified body's assessment report records this justification.

Products without an intended medical purpose follow MDR Article 61(9). For the Annex XVI products, clinical benefit is understood as the performance of the product, and clinical investigations are required unless reliance on clinical data of an analogous medical device is duly justified. The product groups are listed under Annex XVI MDR products without a medical purpose.

Keeping the Evaluation Current with Post-Market Data

Clinical evaluation never ends at certification: MDR Article 2(44) calls it a continuous process, and for class III and implantable devices MDR Article 61(11) requires the PMCF evaluation report and, if indicated, the SSCP to be updated at least annually.

Post-market clinical follow-up is the main engine of the update. Under MDR Annex XIV Part B Section 5, PMCF is a continuous process that updates the clinical evaluation, and the manufacturer addresses it in the post-market surveillance plan. The PMCF plan, its methods and the PMCF evaluation report are covered on the PMCF page listed in the table above.

The update draws on the fourth source of clinical data in MDR Article 2(48): clinically relevant post-market surveillance information, in particular from PMCF. The data come from the system described under post-market surveillance under the MDR and IVDR.

Orphan Devices and MDCG 2024-10

MDCG 2024-10, published in June 2024 and current as of 6 November 2026, explains how the MDCG reads the clinical evaluation of orphan devices. Under section 4.1 of the MDCG 2024-10 guidance, a device counts as an orphan device where it is intended for a disease or condition that affects not more than 12,000 individuals in the EU per year, and where alternatives are insufficient or the device is expected to bring a clinical benefit compared with them.

Both criteria are guidance, and MDCG 2024-10 leaves the Article 61 duty unchanged: an orphan device still needs a clinical evaluation under Article 61 and Annex XIV Part A.

The MDCG Clinical Evaluation Set: Templates and Explanations

MDCG guidance documents explain how the MDR's clinical evaluation rules are applied, but they are not legally binding (MDR Articles 103 and 105), and notified bodies take them into consideration under MDR Annex VII Section 1.6.2. The table lists the documents this page and its linked pages rely on, and the full register is under MDCG guidance.

Documents current on the Commission's MDCG list as of 6 November 2026, with the month the list gives.

On the Commission's list of MDCG endorsed documents, MDCG 2020-13, MDCG 2024-10 and MDCG 2020-6 sit under the heading "Clinical investigation and evaluation, performance studies and evaluation", and MDCG 2020-1 under "New technologies", as of 6 November 2026.

Clinical Evaluation Beyond the MDR Text

Three questions sit at the edge of MDR clinical evaluation: what applies to IVDs, what the pending revision would change, and how the older MEDDEV guidance and templates relate to it. Each is answered briefly below.

How IVDs Are Assessed Instead

IVDs do not undergo clinical evaluation: under the IVDR (Regulation (EU) 2017/746) Article 56 they undergo performance evaluation, built on scientific validity, analytical performance and clinical performance (Article 56(3)). How the three pillars are demonstrated and documented is explained under IVDR performance evaluation.

Software sits at the border of the two regulations. MDCG 2020-1 (March 2020) covers the clinical evaluation of medical device software under the MDR and its performance evaluation under the IVDR, built on valid clinical association, technical performance and clinical performance.

What the Pending Proposal Would Change

Pending: Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)) is at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026, with a draft report of 30 June 2026; it is not law. The stage is recorded in the Legislative Observatory procedure file.

The proposal would delete the Article 61(5) contract condition, allow "same or similar" materials in the equivalence test and add a definition of a well-established technology device. Every amending act and the proposal are listed under MDR and IVDR amendments.

Is MEDDEV 2.7/1 rev.4 still relevant?

MDCG 2020-6 (April 2020) comes with a background note on its relationship with MEDDEV 2.7/1 rev.4; the requirements themselves are in MDR Article 61 and Annex XIV.

Is there an official template for the clinical evaluation report?

The MDCG publishes a template for the notified body's assessment report (MDCG 2020-13) and templates for the PMCF plan and PMCF evaluation report (MDCG 2020-7, MDCG 2020-8, April 2020).