Clinical evaluation and PMCF is the continuous process required by the MDR with which manufacturers use clinical data to demonstrate the safety, performance and clinical benefit of a device (Art. 61, Annex XIV Part A). The PMCF updates this evidence after placing on the market (Part B).
Definition and legal basis
Clinical evaluation is, under Regulation (EU) 2017/745 on medical devices (MDR), a systematic and planned process. It continuously generates, collects, analyzes and assesses clinical data pertaining to a device in order to verify the safety and performance of the device, including its clinical benefit, when used as intended by the manufacturer (Art. 2(44)). It is regulated in Art. 61 and in Annex XIV Part A. Under Art. 10(3), manufacturers carry it out, and it also covers post-market clinical follow-up.
This clinical follow-up after placing on the market is called post-market clinical follow-up (PMCF) and is described in Annex XIV Part B. As a continuous process, it serves to update the clinical evaluation and is addressed in the manufacturer's post-market surveillance plan (see post-market surveillance). Clinical evaluation and PMCF are therefore not separate obligations but one coherent body of evidence across the entire life cycle of the device.
Course of the clinical evaluation
The clinical evaluation is based on clinical data that provide sufficient clinical evidence. The manufacturer specifies and justifies the level of this evidence. It must be appropriate in view of the characteristics of the device and its intended purpose (Art. 61(1)). Annex XIV Part A, Section 1 names five steps:
- establishing and updating a clinical evaluation plan,
- identifying the available clinical data and the gaps in the clinical evidence through a systematic scientific literature review,
- assessing whether the data are suitable for demonstrating safety and performance,
- generating new data through clinical investigations where questions remain open,
- analyzing all data with conclusions on safety, clinical performance and clinical benefit.
Under Art. 2(48), clinical data come from four sources: clinical investigations of the device, studies of a demonstrably equivalent device, clinical experience published in peer-reviewed scientific literature, and clinically relevant information from post-market surveillance, in particular from the PMCF. The evaluation is thorough and objective and takes both favorable and unfavorable data into account. Its thoroughness and extent must be proportionate to the nature, classification, intended purpose and risks of the device (Annex XIV Part A, Section 2).
Anyone relying on data of another device must demonstrate its equivalence, on the basis of technical, biological and clinical characteristics, and must have sufficient access to the data (Annex XIV Part A, Section 3). Clinical investigations are in principle foreseen for implantable devices and Class III devices. Exceptions are regulated in Art. 61(4) to (6). The notified body reviews the clinical evaluation as part of the conformity assessment and documents the result in an assessment report, for which the MDCG provides the template MDCG 2020-13 (July 2020).
Clinical benefit, clinical performance and clinical evidence
The MDR distinguishes three concepts that are often mixed up in reports:
| Term | Meaning under the MDR | Reference |
|---|---|---|
| Clinical benefit | The positive impact of a device on the health of an individual, expressed in terms of meaningful, measurable, patient-relevant clinical outcome(s), or a positive impact on patient management or public health | Art. 2(53) |
| Clinical performance | The ability of a device, resulting from its technical or functional characteristics, to achieve its intended purpose so that, when used as intended, it delivers a clinical benefit | Art. 2(52) |
| Clinical evidence | Clinical data and clinical evaluation results that are sufficient in quantity and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit | Art. 2(51) |
The clinical evaluation plan describes the intended clinical benefits for patients with relevant and specified clinical outcome parameters. It also specifies parameters to be used to determine the acceptability of the benefit-risk ratio for the indications and for the intended purpose (Annex XIV Part A, Section 1(a)). The link to risk management arises from Art. 61(1), which refers to Annex I Sections 1 and 8.
PMCF under Annex XIV Part B
In PMCF, the manufacturer proactively collects and evaluates clinical data from the use of its CE-marked device in or on the human body. The objectives are to confirm safety and performance throughout the expected lifetime, to identify previously unknown side effects and emerging risks, to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use (Part B, Sections 5 and 6.1).
For this purpose, the PMCF plan specifies at least general methods such as gathering clinical experience, obtaining feedback from users and screening of literature, as well as specific methods such as registries or PMCF studies, their rationale, the objectives, a reference to the clinical evaluation and to risk management, and a timeline (Part B, Section 6.2). The manufacturer documents the results in the PMCF evaluation report. Its conclusions feed into the clinical evaluation and risk management, and any necessary preventive or corrective measures are to be implemented (Sections 7 and 8).
The update is not a one-time task. Under Art. 61(11), the clinical evaluation and its documentation are updated throughout the life cycle using the PMCF data and the post-market surveillance plan. For Class III devices and implantable devices, the PMCF evaluation report and, where applicable, the summary of safety and clinical performance are to be updated at least annually.
Reports and documents at a glance
| Document | Purpose | Reference |
|---|---|---|
| Clinical evaluation plan | Specifies intended purpose, target groups, intended clinical benefit, methods and clinical development plan | Annex XIV Part A, Section 1 |
| Clinical evaluation report (CER) | Records the results and the clinical evidence; part of the technical documentation, except for custom-made devices | Art. 61(12), Annex XIV, Section 4 |
| PMCF plan | Describes methods and procedures of the PMCF; part of the post-market surveillance plan; template MDCG 2020-7 | Annex XIV Part B, Section 6 |
| PMCF evaluation report | Documents the results of the PMCF; part of the CER; template MDCG 2020-8 | Annex XIV Part B, Section 7 |
| Summary of safety and clinical performance (SSCP) | For implantable devices and Class III; publicly accessible via EUDAMED | Art. 32 |
| Periodic safety update report (PSUR) | For Classes IIa, IIb and III; states the main findings of the PMCF | Art. 86 |
The CER and the PMCF evaluation report are part of the technical documentation (see CE marking and technical documentation). By their own statement, the MDCG templates are not legally binding and are intended to facilitate a consistent and complete presentation. The Commission page on MDCG documents continues to list MDCG 2020-7, 2020-8 and 2020-13 as templates for clinical evaluation and PMCF (as of October 2026).
Usability in the clinical evaluation
The MDR does not require a separate usability section in the CER. Several requirements do touch on the topic, however, and these links can be documented:
- Target groups and intended purpose: The plan must specify the intended target groups precisely. This requires reliable information on user profiles and intended users.
- Annex I, Section 5: Manufacturers reduce risks resulting from use errors by taking into account ergonomic features and the environment of use, as well as the knowledge, experience and training of the intended users, whether lay persons or professionals. The clinical evaluation confirms conformity with the relevant general requirements (Art. 61(1)).
- Assessment by the notified body: According to MDCG 2020-13, the clinical evaluation is to be aligned with risk management, post-market surveillance, the PMCF plan and the instructions for use. The assessment grid asks, among other things, whether the device is intended for professionals or lay persons, whether the instructions for use contain all relevant information for the intended user, and whether training is necessary as a risk control measure.
- Data from the market: An incident also includes a use error due to ergonomic features (Art. 2(64)). The PMCF is to obtain user feedback and identify systematic misuse. Under Art. 83(3)(f), post-market surveillance also serves to improve usability. MDCG 2025-10 (December 2025) emphasizes the link to design and development in this respect.
For context: The summative evaluation under IEC 62366-1 (see summative usability evaluation) remains a separate piece of evidence within the usability engineering process. The MDR and the MDCG templates mentioned do not require its results to be included in the CER. Use errors from the field, for example from complaints or PMCF data, should, however, flow back into the use-related risk analysis and risk management (see use error). In the US, the comparable level of evidence for Class III is based on the PMA.
Under the MDR (Art. 61, Annex XIV Part A), clinical evaluation is a planned, continuous process. The manufacturer evaluates clinical data from investigations, literature and post-market surveillance and uses them to demonstrate safety, performance and clinical benefit of its device. The result is recorded in the clinical evaluation report.
Post-market clinical follow-up (PMCF, Part B) proactively collects clinical data from the market. The PMCF keeps the clinical evaluation up to date across the entire life cycle and is part of post-market surveillance.
For usability, the MDR names no separate section in the report. Points of contact are target groups, Annex I Section 5, the alignment with risk management and instructions for use, and feedback from users in the market.
Frequently asked questions (FAQ)
What is the difference between clinical evaluation and a clinical investigation?
Clinical evaluation is the entire systematic process of collecting, analyzing and assessing clinical data. A clinical investigation is only one possible data source, namely a systematic investigation with human subjects. Data can also come from scientific literature on an equivalent device and from post-market surveillance.
What is PMCF, and is it always required?
PMCF stands for post-market clinical follow-up. Under Art. 10(3) MDR, the clinical evaluation also covers the PMCF. If no PMCF is carried out, the notified body, according to MDCG 2020-7, also assesses the justification for this.
How often must the clinical evaluation be updated?
The MDR requires an update throughout the life cycle of the device based on the PMCF data and post-market surveillance. For Class III devices and implantable devices, the PMCF evaluation report and, where applicable, the summary of safety and clinical performance are to be updated at least annually.
Who reviews the clinical evaluation report?
The notified body reviews the clinical evaluation as part of the conformity assessment and documents its assessment in an assessment report. For this purpose, the MDCG has published the template MDCG 2020-13, which is not legally binding.
Does usability play a role in the clinical evaluation?
Yes, indirectly. The clinical evaluation confirms conformity with the relevant requirements of Annex I, which include reducing risks from use errors. The notified body's assessment asks about intended users, instructions for use and training. The summative evaluation under IEC 62366-1 nevertheless remains a separate piece of evidence.
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More about our usability engineeringSources
- Regulation (EU) 2017/745 on medical devices (MDR)
- EUDAMED, European Database on Medical Devices
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971:2019, Medical devices, Application of risk management to medical devices
- MDCG 2020-7, Post-market clinical follow-up (PMCF) Plan Template (April 2020)
- MDCG 2020-8, Post-market clinical follow-up (PMCF) Evaluation Report Template (April 2020)
- MDCG 2020-13, Clinical evaluation assessment report template (July 2020)
- MDCG 2025-10, Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025)