MDR Clinical Evaluation: Article 61, Annex XIV, and the 2026 Exemption List

Updated October 2026. Scope: clinical evaluation under the EU MDR, Regulation (EU) 2017/745, Article 61 and Annex XIV, including the July 2026 change to the list of devices exempt from clinical investigations.

Key takeaways

• A frequent failure: in practice, insufficient clinical evidence or unsupported equivalence claims, which notified bodies raise as nonconformities and which can delay certification.
• What it is: MDR clinical evaluation is a planned, continuous process that collects and assesses clinical data to show a device is safe, performs as intended, and delivers its clinical benefits.
• What Article 61 requires: you set and justify the level of clinical evidence your device needs, then plan, conduct, and document the evaluation under Part A of Annex XIV.
• The July 2026 change: Delegated Regulation (EU) 2026/1451 extends the exemption from clinical investigations to more than fifty additional types of well-established devices, provided the clinical evaluation is based on sufficient clinical data and complies with any relevant product-specific common specification.
• What did not change: an exemption from clinical investigations is never an exemption from clinical evaluation.

What MDR clinical evaluation is

The MDR 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.”

Two words in that definition do most of the work. “Planned” means you write the method down before you collect evidence. “Continuously” means the evaluation does not end at certification.

Clinical data, under the MDR, can come from four sources:

• Own investigations: clinical investigations of the device itself.
• Equivalent-device studies: clinical investigations or other studies in the scientific literature on a device shown to be equivalent.
• Published experience: peer-reviewed literature on other clinical experience with the device or an equivalent device.
• Post-market data: clinically relevant post-market surveillance information, in particular post-market clinical follow-up (PMCF).

What Article 61 requires

Article 61(1) requires the manufacturer to “specify and justify the level of clinical evidence necessary to demonstrate conformity” with the relevant General Safety and Performance Requirements, appropriate to the device’s characteristics and intended purpose. Article 61(3) then requires “a defined and methodologically sound procedure” based on:

• a critical evaluation of the relevant scientific literature, where equivalence is demonstrated and the data adequately show compliance;
• a critical evaluation of the results of all available clinical investigations;
• a consideration of currently available alternative treatment options, if any.

Because the intended purpose sets what has to be proven, getting the intended use and indications right comes before any evidence work.

There is one narrow alternative route. Under Article 61(10), where demonstrating conformity on the basis of clinical data is not deemed appropriate, the manufacturer must give adequate justification based on its risk management and the specifics of the device’s interaction with the body, and must substantiate in the technical documentation why non-clinical testing alone is adequate. This does not affect the clinical investigation requirement for implantable and class III devices.

The clinical evaluation plan and process

Annex XIV, Part A sets out what the plan must contain and how the evaluation runs. The plan must include at least:

• the General Safety and Performance Requirements that need support from clinical data;
• the intended purpose, target groups, indications, and contra-indications;
• the intended clinical benefits, with specified clinical outcome parameters;
• the methods for examining clinical safety, including residual risks and side-effects;
• the parameters used to judge whether the benefit-risk ratio is acceptable, based on the state of the art in medicine;
• how benefit-risk issues for specific components, such as pharmaceutical substances or non-viable animal or human tissues, are addressed;
• a clinical development plan, from exploratory investigations such as first-in-man, feasibility, and pilot studies, through confirmatory investigations and PMCF, with milestones and potential acceptance criteria.

The evaluation then proceeds through a systematic literature review to identify relevant data and gaps, an appraisal of each dataset’s suitability, new clinical investigations where gaps remain, and an analysis that reaches conclusions on safety, clinical performance, and clinical benefit. Annex XIV requires the evaluation to be “thorough and objective” and to take into account both favourable and unfavourable data, with depth proportionate to the device’s classification, risks, and claims.

Equivalence

A clinical evaluation can rely on data from another device if equivalence is demonstrated. Annex XIV, Section 3 requires similarity on three fronts:

The characteristics must be similar “to the extent that there would be no clinically significant difference” in safety and clinical performance, and manufacturers must clearly demonstrate sufficient levels of access to the data on the device they claim equivalence to. MDCG 2020-5 is the guidance on equivalence.

When clinical investigations are required

Article 61(4) states that for implantable and class III devices, clinical investigations shall be performed, unless an exception applies. The exceptions are:

• Own modified device (Article 61(4)): the device is a modification of a device already marketed by the same manufacturer, equivalence is demonstrated under Annex XIV, Section 3 and endorsed by the notified body, and the clinical evaluation of the marketed device is sufficient for the modified device. The notified body also checks that the PMCF plan is appropriate and includes post-market studies.
• Another manufacturer’s device (Article 61(5)): the same route is available for a device equivalent to another manufacturer’s marketed device, but only if the two manufacturers have a contract that explicitly allows full access to the technical documentation on an ongoing basis, and the original clinical evaluation complies with the MDR, with clear evidence of that provided to the notified body.
• Legacy devices (Article 61(6)(a)): devices lawfully placed on the market under the old directives whose clinical evaluation is based on sufficient clinical data and complies with any relevant product-specific common specification.
• Well-established technologies (Article 61(6)(b)): devices on the list set out in that point.

Where a device relies on the Article 61(6) exemptions, the manufacturer must justify this in the clinical evaluation report, and the notified body in its clinical evaluation assessment report (Article 61(7)).

The July 2026 change: Delegated Regulation (EU) 2026/1451

Article 61(8) empowers the Commission, where justified by well-established technologies or by public health, to add device types to the 61(6)(b) list or remove them from it. It used that power in Commission Delegated Regulation (EU) 2026/1451, adopted on 20 March 2026, published in the Official Journal on 29 June 2026, and in force since 19 July 2026.

The regulation replaces point (b). The original list stays: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. More than fifty further types are added. The regulation lists them as a single series; the grouping below is ours:

• Dental and orthodontic: dental implants, orthodontic devices, dental barriers, dental veneers, transpalatal distractors.
• Bone and orthopaedic: bone substitutes, bone fillers, bone wax, bone tacks, nails, anchors, spinal posterior fixations, stem centralisers.
• Vascular access and cardiac: guidewires, pressure wires, pacing wires and leads, lead caps, introducers, dilators, port catheters, endovascular embolisation coils, embolisation particles, internal defibrillation paddles.
• General and surgical: needles, needle holders, forceps, cannulas, stylets and stylet guides, feeding tubes, ventricular drains, gastrostomy buttons, shunts, and reusable surgical instruments.

The full list is in the regulation. The Commission’s stated reasoning is that these devices have common, simple, and stable designs; well-known safety, with no past association with safety issues; well-known clinical performance as standard of care devices with little evolution in indications or the state of the art; and a long history on the Union market. The same condition applies as before: the clinical evaluation must be based on sufficient clinical data and comply with any relevant product-specific common specification.

The regulation’s recitals are explicit that manufacturers of these devices “are nonetheless required to plan, conduct and document a clinical evaluation in accordance with Article 61” of the MDR. MDCG 2023-7 gives guidance on the exemptions and on access to data for equivalence claims; it was published in December 2023, before this amendment, so read it against the new list.

Keeping the evaluation current

The clinical evaluation report must document the evaluation, its results, and the clinical evidence, and, except for custom-made devices, it forms part of the technical documentation (Article 61(12)). It is also a living document. Article 61(11) requires it to be updated throughout the device’s life cycle with data from the PMCF plan and the post-market surveillance plan. For class III and implantable devices, the PMCF evaluation report and, where applicable, the summary of safety and clinical performance must be updated at least annually.

PMCF itself, under Annex XIV, Part B, is the continuous process that feeds the evaluation: proactively collecting clinical data to confirm safety and performance over the device’s lifetime, identify unknown side-effects and emerging risks, confirm the benefit-risk ratio stays acceptable, and identify systematic misuse or off-label use.

Standards and guidance

Two standards matter here, and neither replaces the regulation:

• ISO 14155:2026 covers good clinical practice for clinical investigations, not clinical evaluation as a whole. It is the fourth edition and replaced ISO 14155:2020.
• ISO 18969, Clinical evaluation of medical devices: Principles and process for planning and performing clinical evaluation, is the ISO standard being developed specifically for clinical evaluation. As of 16 October 2026 it is a final draft (FDIS) in the approval phase and not yet published, and it does not apply to in vitro diagnostic devices. See our guide to ISO 18969 and what it changes.

Even once published, it would give a presumption of conformity under the MDR only if its reference is published in the Official Journal as a harmonised standard (Article 8). Until then, clinical evaluation methodology under the MDR is shaped by Article 61, Annex XIV, and MDCG guidance, which supports the regulation but is not law:

MEDDEV 2.7/1 rev.4, written under the old directives, is still referenced, and the Commission publishes a background note on how it relates to MDCG 2020-6.

Frequently asked questions

What is clinical evaluation under the EU MDR?
A systematic, planned, and continuous process to generate, collect, analyse, and assess clinical data on a device, in order to verify its safety and performance, including its clinical benefits, when used as intended. Article 61 and Annex XIV set out how it must be done.

What is the difference between clinical evaluation and a clinical investigation?
A clinical investigation is a study in human subjects that generates new clinical data. Clinical evaluation is the overall assessment of all relevant clinical data, which may include investigations, literature, equivalent-device data, and post-market data. A device can be exempt from investigations but never from evaluation.

Which devices need a clinical investigation under the MDR?
Implantable and class III devices generally do, under Article 61(4), unless an exception applies: qualifying modifications of the manufacturer’s own marketed device, equivalence to another manufacturer’s device with a full-access contract, certain legacy devices, or devices on the well-established technologies list in Article 61(6)(b). Delegated Regulation (EU) 2026/1451 added more than fifty device types to that list from 19 July 2026.

Is there an ISO standard for clinical evaluation?
One is close. ISO 18969, Clinical evaluation of medical devices, is a final draft (FDIS) in the approval phase and had not been published as of 16 October 2026; it will not apply to in vitro diagnostic devices. ISO 14155:2026 covers good clinical practice for clinical investigations, not clinical evaluation as a whole. For now, clinical evaluation under the MDR is governed by Article 61 and Annex XIV, supported by MDCG guidance such as MDCG 2020-5 on equivalence.

How often must a clinical evaluation be updated?
Throughout the device’s life cycle, using data from PMCF and post-market surveillance. For class III and implantable devices, the PMCF evaluation report and, where applicable, the summary of safety and clinical performance must be updated at least annually.

Related guides and services

• Regulatory Affairs support from CENIT Consulting: clinical evidence and gap mapping against the GSPR, PMS and PMCF planning, notified body response support, and a case-by-case review of whether the updated exemption list is relevant to your device.
• Quality management support: the post-market surveillance and PMCF processes that keep the clinical evaluation current.

For the requirements clinical evidence must support, see the guide to the General Safety and Performance Requirements. For devices still transitioning from the directives, see the guide to legacy medical devices under the MDR.

This article is for general information only and is not legal or regulatory advice. Teams remain responsible for regulatory decisions and staying current with applicable regulations and guidance.

Talk to CENIT Consulting about your clinical evaluation: book a 30-minute consult.