Navigate the clinical requirements for your medical device.
Navigate the clinical requirements for your medical device.
Clinical Data
Clinical data is the evidence to demonstrate and continuously support clinical benefit, safety, and performance that is generated from the use of a device(s) and is sourced from the following:
Clinical Data sourced from Scientific Literature
A clinical evaluation may be based on clinical data published in scientific literature relating to the device under evaluation or to a device for which equivalence to the device under evaluation was demonstrated.
For the appropriate literature search, a search protocol is necessary. Here the manufacturer should clearly identify the adequacy of search terms: for example, it should be sufficiently broad to establish benchmarks, determine the general state of the art, determine potential risk, adverse events, and undesirable side-effects, as written in MDCG 2020-13.
Following this guidance, more aspects of an appropriate and transparent literature search and literature appraisal shall be considered, such as multiple databases should be used, both favorable and unfavorable data must be included.
For further guidance see MDCG 2020-13.
Equivalence under MDR
The following technical, biological and clinical characteristics MUST be considered for the demonstration of equivalence (MDR Annex XIV part A 3):
Technical: the device is of SIMILAR design, conditions of use, 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 and 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 leachable.
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 (age, anatomy and physiology) has the SAME kind of user and SIMILAR relevant critical performance.
For further guidance see MDCG 2020-5.
Clinical Evaluation Consultation Procedure (CECP) and Article 54
A CECP will be mandatory in cases when performing a conformity assessment of certain high-risk devices. A CECP (MDR Article 54.1) is applicable for class III implantable and IIb active devices intended to administer and/or remove a medicinal product according to Rule 12, unless article 54.2 can be applied. Here, an independent panel of experts in the particular medical field will provide a scientific opinion.
For further guidance see MDCG 2019-3.
Clinical Data sourced from clinical investigation of the device under evaluation
Clinical investigation of medical devices is any systematic investigation, undertaken to assess the safety, performance, and clinical benefit. Clinical investigations shall be based on a plan that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of the clinical investigation.
The MDR sets the legal framework in Annex XV on clinical investigation of medical devices including the involvement of the competent authorities and the ethical committees.
For further guidance see ISO 14155, MDCG 2021-6 and MDCG 2024-3.
Clinical Evaluation
Article 61 and Annex XIV of the MDR outline the necessary steps and requirements for conducting a clinical evaluation. Regardless of their classification, all medical devices that shall be subject to a conformity assessment under the MDR require a clinical evaluation. Clinical evaluation is a systematic and planned process to continuously generate, collect, appraise, analyse, and evaluate the clinical data to demonstrate the safety and performance, including clinical benefits, of the medical device under assessment when used as intended by the Manufacturer. A clinical evaluation may also be based on clinical data relating to a medical device for which equivalence to the device under evaluation can be demonstrated.
A clinical evaluation must be thorough and objective and must consider both favourable and unfavourable clinical data. The manufacturer shall specify and justify the level of evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. Its depth and extent shall be proportionate and appropriate to the classification, intended purpose and risks of the medical device in question, as well as to the Manufacturer’s claims.
In addition, there are multiple MDCG guidelines that can be taken into consideration, specifically MDCG 2020-13.
Clinical Evaluation Plan (CEP)
The CEP is the backbone of clinical evaluation and outlines the methodology, objectives, and criteria for conducting clinical evaluation providing a structured approach to gathering, appraising, analyzing, and interpreting clinical data. CEP must follow the requirements laid out in Annex XIV, Part A, 1.a of the MDR.
Clinical Evaluation Report (CER)
The results of the clinical evaluation and the clinical evidence must be documented in a clinical evaluation report which is part of the conformity assessment of the device under evaluation.
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.
The clinical evaluation shall be kept up to date throughout the lifecycle of the device under evaluation (MDR Art 61.11).
For further guidance see MDCG 2020-13.
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