a clear specification of intended target groups with clear indications and contra-indications;
—
a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
—
a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
—
an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;
—
an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
—
a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria;
appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device;
(d)
generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and
The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
3.
A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
—
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
—
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
—
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.
The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question.
Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation.
PART B
POST-MARKET CLINICAL FOLLOW-UP
5.
PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
6.
PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
6.1.
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
(a)
confirming the safety and performance of the device throughout its expected lifetime,
(b)
identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
(c)
identifying and analysing emergent risks on the basis of factual evidence,
(d)
ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
(e)
identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
6.2.
The PMCF plan shall include at least:
(a)
the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
(b)
the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
(c)
a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.
7.
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
8.
The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
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Related guidance (28)
Current English catalogue entries that refer to Annex XIV. Guidance is non-binding and kept separate from the regulation text.
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MDCG 2021-24 rev.1Guidance on classification of medical devicesApril 2026⌄
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MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devicesDecember 2019⌄
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MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024⌄
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MDCG 2024-5 MDCG 2024-5 Appendix AGuidance on the Investigator’s Brochure contentAppendix A of the MDCG 2024-5April2024April2024⌄
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MDCG 2024-3 MDCG 2024-3 Appendix AGuidance on content of the Clinical Investigation Plan for clinical investigations of medical devicesClinical Investigation Plan Synopsis TemplateMarch 2024March 2024⌄
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MDCG 2023-7Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalenceDecember 2023⌄
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MDCG 2020-13 - Word versionClinical evaluation assessment report templateJuly 2020⌄
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Show all 28 guidance documentsShow only the first 8
MDCG 2020-8Guidance on PMCF evaluation report templateApril 2020⌄
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MDCG 2020-7Guidance on PMCF plan templateApril 2020⌄
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MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesBackground note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluationApril 2020⌄
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MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020⌄
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MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022⌄
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MDCG 2023-1Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746January 2023⌄
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MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025⌄
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MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025⌄
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MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020⌄
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MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesJuly 2020⌄
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MDCG 2024-6Preliminary re-assessment review (PRAR) form template (MDR)May 2024⌄
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MDCG 2024-7 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexPreliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents)January 2025⌄
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MDCG 2021-15 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)Annex to Application Form & PAR Template MDR (List of documents)January 2025⌄
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MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020⌄
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MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023⌄
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MDCG 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025⌄
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MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022⌄
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Q&A rev.2Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsJuly 2024⌄
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MDCG 2021-25 rev.1Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EECOctober 2024⌄
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SCHEER guidelinesUpdate on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devicescovering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) propertiesJune 2024⌄
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