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MDR Medical Device Conformity Assessment Training
Practice-oriented, 10-month training
Starting Date: 30 January 2026
MDR: Clinical Evaluation in the focus of Conformity Assessment
It is no exaggeration to say that the MDR has declared war on a number of anomalies by making clinical evaluation the focus of conformity assessment of medical devices.
Even before the MDR Regulation, steps had been taken to introduce clinical validation practices based on objective evidence. The big step was taken in Document MEDDEV 2.7/1 rev. 4, but there are still many open questions.
One thing is for sure: the MDR Regulation has taken those medical devices as the basis for defining the requirements for clinical evaluation which have the most critical features.
Let’s take a look at the requirements for clinical evaluation under the MDR!
I. Requirements of Clinical Evaluation under MDR
The legal requirement is rather narrow: Article 61 (3) of the MDR Regulation.
(3) A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
(a) a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
— it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and
— the data adequately demonstrate compliance with the relevant general safety and performance requirements;
(b) a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
(c) a consideration of currently available alternative treatment options for that purpose, if any.
There is an obvious desire by manufacturers to set (economically) reasonable expectations when clinically evaluating their own products. The manufacturer should develop its own policies for planning, conducting, evaluating, monitoring, documenting and collecting clinical data for clinical evaluation. This regulation should be in line with the legal requirements of the MDR Regulation for clinical investigations, standard requirements (ISO 14971) and existing guidelines.
Regulations are part of the manufacturer’s mandatory quality management system, typically quality management procedures. The procedure developed, together with the clinical evaluation based on it, will demonstrate compliance with the legal requirements. There is an obvious interplay: the more detailed the procedure, the more focused the clinical evaluation itself can be, and vice versa, if the procedure is very sketchy, the clinical evaluation should include detailed justifications.
II. Steps and the Process of Clinical Evaluation
a.) Introduction
The clinical evaluation involves the identification, analysis and assessment by the manufacturer of the relevant clinical data available for the device to determine whether it provides sufficient clinical evidence to demonstrate compliance with the general requirements for the safety and performance of the device.
If the clinical data available for the device do not meet the level of clinical evidence set by the manufacturer, additional clinical data should be collected and evaluated.
Data that do not demonstrate that the general requirements for safety and performance of the device are met do not meet the level of clinical evidence.
It can be a source of clinical data:
- from a clinical investigation on the device,
- from the equivalent device test,
- from the peer-reviewed scientific literature,
- from Post-Market Clinical Follow-up (PMCF) activities
from clinically relevant data.
If the level of clinical evidence is satisfactory, the results of the clinical data evaluation must be documented in the clinical evaluation report, i.e. a clinical evaluation of the medical device must be carried out, which, if satisfactory, will allow the device to be CE marked and legally placed on the market (Important note: for devices classified higher than Class I devices, manufacturers must also have the clinical evaluation reviewed by a notified body designated for this purpose, which carries out the conformity assessment.)
b.) Step 5 of the Clinical Evaluation described in MEDDEV 2.7/1 re. 4.
Figure 1: The 5 steps of the clinical evaluation in MEDDEV 2.7/1 rev. 4.
Step 0:
Step 0 of the Clinical Evaluation Process describes the scope of the evaluation and the trial setting, including which products/models/settings are covered by the clinical evaluation. It describes the technical content on which the device is based, the conditions of use and the intended purpose of the device. Include any statements that relate to the clinical performance or clinical safety of the device.
Step 1:
Step 1 of the clinical evaluation process is the identification of the cornerstone data, which explains the strategy for the literature search and describes the nature and scope of the selected clinical data and relevant preclinical data.
Step 2:
Step 2 of the clinical evaluation process is the assessment of the core data, which describes the criteria used by the evaluators to judge the data sets, summarises the core data sets (methods, results, authors’ conclusions), and assesses the methodological quality, scientific validity, role in the evaluation, weighting associated with the evidence, and any limitations, and justifies the rejection of certain data or documents. Criterion data should be of the quality necessary to demonstrate the adequate clinical performance and clinical safety of the investigational device. The investigation data shall be generated either by the device under investigation, during its normal use / appropriate use, or by an equivalent device.
Step 3:
Step 3 of the clinical evaluation process is the analysis of the clinical data, which shows whether and how the information listed as reference (e.g. evidence of compliance with the requirements of harmonised standards and clinical data) and the clinical data constitute sufficient clinical evidence of the clinical performance and clinical safety of the investigational device. The analysis of clinical data will also demonstrate whether adequate data are available for all aspects of the intended purpose and for all products/models/adjustments reviewed by the clinical evaluation. The analysis shall describe the benefits and risks of the device (their nature, likelihood, magnitude, duration and frequency) and demonstrate the acceptability of the benefit/risk profile in the light of current knowledge/ state of the art in the relevant medical specialties. The analysis shall refer to applicable standards and guidelines, available treatment alternatives and shall support the conclusion that all general requirements for the clinical characteristics of the device are met.
Step 4:
Step 4 of the clinical evaluation process is the finalisation of the Clinical Evaluation Report (CER). The clinical evaluation report summarises the assessment of all relevant clinical data recorded or referred to in the full technical documentation. The Clinical Evaluation Report (CER) and the relevant clinical data constitute the clinical evidence for the conformity assessment.
c.) Step 5 of Clinical Evaluation under Annex XIV of the MDR
Annex XIV of the MDR also identifies 5 elements for clinical evaluation:
a. Establishing and updating a Clinical Evaluation Plan (CEP) in accordance with the current state of the art.
b. Identification of available clinical data relevant to the device and its intended purpose, and any gaps in clinical evidence, through a systematic review of the literature.
c. Evaluating all relevant clinical data for their suitability for establishing the safety and performance of the device.
d. Generating new or additional clinical data necessary to address outstanding issues, through properly designed clinical investigations in accordance with the clinical development plan.
e. Analysing all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.
Figure 2: The 5 steps of the clinical evaluation according to Annex XIV of the MDR
III. The Clinical Evaluation Plan (CEP)
The evaluation of clinical data should be planned by the manufacturer, by preparing a so-called clinical plan. The requirements for the Clinical Evaluation Plan (CEP) are set out in Annex XIV, Part A, point 1 of the MDR Regulation.
The manufacturer must develop and maintain a Clinical Evaluation Plan (CEP), which is necessary to ensure systematic and unbiased assessment of the data, describing the process of assessment,and the criteria to be used.
The Clinical Evaluation Plan (CEP) should be part of the content of the technical documentation.
The requirements for the content of the Clinical Evaluation Plan (CEP) are:
- Definition of general safety and performance requirements, that require the use of relevant clinical data.
- The intended purpose of the asset is defined.
- Identification of target groups and indication of indications and contraindications.
- Description of the expected clinical benefits for the patient using relevant clinical outcome indicators by specifying.
- To be used to assess quantitative and quality aspects of clinical safety a description of the methods used (with an identification of any residual risks and side effects).
- Indication of whether, in the light of the current state of medical knowledge, it is acceptable to list and describe the parameters necessary to determine the benefit/risk ratio for the different indications and intended purpose(s) of the device.
- Issues related to the risks and benefits of specific starting materials (e.g. pharmaceutical use, non-viable animal or human tissues).
- Clinical Development Plan (CDP) – must include all the steps from exploratory studies to proof-of-concept investigators, PMCFs.
IV. Checking the content of the Clinical Evaluation Plan (CEP)
With regard to the content of the Clinical Evaluation Plan (CEP), it should be checked that a clinical evaluation plan is available for all medical devices. In addition, it must be checked that the content of the Clinical Evaluation Plan (CEP) complies with the requirements of Annex XIV, Part A, point 1(a) of the MDR Regulation. Continuous process of updating the Clinical Evaluation Plan and checking that the Clinical Evaluation Plan is part of the technical documentation.
It should also be checked whether the “gap analysis” under the MDR Regulation has been carried out for Legacy devices in accordance with the MDCG 2020-6 guide [“Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and notified bodies”] and whether a Clinical Evaluation Plan (CEP) has been prepared on this basis. This plan should include a reassessment of alternative treatment options, a reinterpretation of the relevant clinical data, whether, where appropriate, the demonstration of equivalence is still appropriate and whether the manufacturer has taken into account the experience gained and complaints about the device during the PMS.
The Clinical Evaluation Plan (CEP) should include:
- To define general safety and performance requirements that require the use of relevant clinical data.
- The intended purpose of the asset is defined.
- Identification of target groups and indication of indications and contraindications.
- Description of the expected clinical benefits for the patient, with relevant clinical outcome indicators.
- A description of the methods to be used to assess quantitative and quality aspects of clinical safety (with identification of residual risks and adverse reactions).
- A list and description of the parameters necessary to determine the benefit/risk ratio for the different indications and the intended purpose(s) of the device, according to the current state ofknowledge.
- Information on the risks and benefits of specific raw materials (e.g. pharmaceutical use, non-viable animal or human tissues).
- A Clinical Development Plan (CDP) from exploratory first-in-man studies through proof-of-concept clinical trials to post-market clinical follow-up.
V. Evaluation of Clinical Data
The manufacturer should assess, identify, analyse and evaluate clinical data (as set out in the previous paragraphs) and justify the relevance and any limitations of the data identified in terms of compliance with the general requirements for safety and performance and risk analysis. The manufacturer shall identify all clinical data relevant to the device, both favourable and unfavourable, and shall use a well-established, reproducible and systematic search strategy. The intended safety, patient benefit and clinical performance should be supported by clinical data.
The manufacturer must specify the construction characteristics and intended purpose of the device in order to demonstrate compliance with each relevant general requirement. The manufacturer shall carry out a critical assessment of the relevant scientific literature and data relating to the safety, benefits, performance, design characteristics and intended purpose of the device.
When analysing and evaluating clinical data, the acceptable risk/benefit profile, performance requirements and requirements for the acceptability of adverse reactions should be supported by appropriate clinical evidence during the device conformity assessment.
The clinical evaluation should demonstrate that the risks associated with the intended purpose are minimal, acceptable in relation to the benefits and that a high level of health and safety protection is ensured.
The instructions for use (IFU) should adequately describe the intended use of the device and should be supported by sufficient clinical evidence. The instructions for use (IFU) shall contain appropriate information to reduce the risk of use error, provide information on residual risks and how to manage them, and be supported by sufficient clinical evidence. The positive impact of the device on the health of the individual should be relevant and measurable for the patient. The nature, magnitude, likelihood and duration of the benefits should be considered.
Examples of such benefits include:
- a positive clinical outcome,
- improving the patient’s quality of life,
- to improve the accuracy of diagnosis,
- favourable public health indicators.
The risk management documents should make decisions on the risks associated with the instrument and how they will be managed. The clinical evaluation should address the significance of any risks that remain after the manufacturer has taken measures to mitigate the risks.
When assessing the acceptability of the risk/benefit profile of an instrument, several criteria need to be considered:
- Are the clinical data on benefits and risks acceptable in relation to the current state of the art in the relevant scientific field?
- Are they applicable to all health conditions and populations defined as the intended purpose?
- What restrictions should be proposed for specific populations and/or health conditions?
It is therefore necessary to identify and define the current state of knowledge, including the relevant tools and alternative treatment options available to the target audience.
For devices, it must be demonstrated that they meet the parameters and fulfil the purpose specified by the manufacturer.
This includes any direct and indirect health effects on humans, as well as clinical therapeutic and diagnostic benefits for patients, resulting from the technical or functional properties of the device when used as intended (e.g. the number of independent imaging directions, the reproducibility of image processing, and the diagnostic sensitivity and specificity of a test in key clinical indications).
Any adverse event must be of acceptable risk compared to the intended performance.
Clinical data are needed to assess the acceptability of adverse reactions and to evaluate the nature, severity and frequency of any adverse reactions. In order to assess the acceptability of adverse reactions, clinical data should be based on an adequate number of observations and should take into account the current state of the art. In judging acceptability, consideration should be given to the current treatment alternatives available to patients and to objective performance criteria set out in relevant standards and guidelines. If there is a lack of clinical data or insufficient number of observers, the device does not meet the requirement for acceptability of adverse reactions.
Author: Tímea Markóné Németh (NoBoMed Zrt.) and György Balázs (EMKI-Cert kft.)
This is an excerpt of the training materials of the NoBoVersum course ‘MDR Medical Device Conformity Assessment Training‘.