There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro Diagnostic Regulation; this is why having a well documented clinical evaluation plan is of fundamental importance to properly support regulatory submission and CE marking process.
We have already been extensively previously discussed about clinical process according to EU MDR, talking about ISO 14155 , clinical evaluation, Summary of Safety and Clinical Performance and Post-Market Clinical Follow-up.
In this article we will discuss about the requirements related to Clinical Evaluation Plan according to the requirements set in the European Medical Device Regulation.
Before entering into the details of the requirements associated to the Clinical Evaluation Plan, we remind that 4EasyReg offers a Clinical Evaluation Procedure fully aligned with the requirements of the EU MDR 2017/745. The procedure is designed to cover all the necessary parts of the clinical evaluation process, including literature search, equivalence and clinical investigation.
Requirements for Clinical Evaluation Plan
The specific requirements for clinical evaluation are set within Annex XIV of the regulation. In this specific Annex, the requirements for the Clinical Evaluation Plan are described in point 1. We are now going through all the specific requirements that need to be covered by the Clinical Evaluation Plan.
1. General safety and performance requirements and clinical evaluation plan
The first item that need to be mentioned in the clinical evaluation plan is the list of General Safety and Performance Requirements (GSPRs) that need support from clinical data in order to demonstrate compliance. As reminder, the GSPR are reported in Annex I of the Regulation (either MDR 2017/745 or IVDR 2017/746) and they are the basic requirements needed to demonstrate the safety and performance of the device on the European Market. Although compliance to some of these requirements can be demonstrated by respecting the requirements of specific (harmonised) standards, such as for example ISO 14971, ISO 62366 or ISO 10993, other GSPR need to be supported by clinical data.
For this reason, in the clinical evaluation plan it is necessary the highlight the GSPRs which need to be supported by clinical data, to make sure all the identified inputs are properly identify in the planning phase of the clinical evaluation.
2. The intended purpose of the device
The clinical evaluation plan shall include the intended purpose of the device. It is very important to mention that the device needs to fulfil the definition of medical device set in Article 2 of the EU MDR. Moreover, the device should not fall in the list of devices specified in Annex XVI of the regulation, the so-called devices without an intended medical purpose. In fact, for these devices, clinical evaluation may not be necessary to evaluate their performance.
3. Target Population, Indications and Contraindications
Another fundamental point in the context of an efficient clinica evaluation plan is the description of the target population, the indications for use and contraindications applicable to the specific device. This information shall be fully aligned with what is mention with IFU and labelling, in compliance with ISO 20417.
4. Description of the Intended Medical Benefit and clinical outcome parameters
The medical benefit of the devices need to be properly mention within the Clinical Evaluation Plan. Typically this benefit may already been properly described in the context of the risk-benefit analysis, as part of the risk management process.
5. Methods to be used for examination of qualitative and quantitative aspects of clinical safety
Going more in details into the clinical aspects of the clinical evaluation plan, it is necessary to properly specify the qualitative and quantitative aspects needed to be evaluated from clinical stand point in order to properly demonstrate the safety of the device. This is obviously related to the design a clinical investigations study; for example if specific endpoints have been selected, it is necessary too mention them in the clinical evaluation plan as these will be used to demonstrate safety and performance of the device.
6. List of Parameters to be used to determine the acceptability of the benefit risk analysis
This point is again linked to the risk management process and the so-called risk benefit analysis. In fact, it is necessary to define specific threshold needed to determine the acceptability of the risk-benefit ratio, to ensure the device is safe and the potential risks are justified by the clinical benefit of the device.
7. Management of benefit-risk ratio related to specific components such use of pharmaceutical, non-viable animal or human tissues
A specific section of the clinical evaluation plan shall be dedicated to the management of benefit risk analysis in relation to specific medical device used in combination with pharmaceutical products or devices that contain non-viable animal or human tissues. in fact these devices have specific requirements to respect, mainly related to ISO 22442. Devices containing pharmaceutical compounds need special considerations in relation to the metabolism of the specific pharmaceutical compounds (ADME: absorption, distribution, metabolism, and excretion).
8. Clinical Development Plan
The last requirements mentioned in the point 1 of Annex XIV of the EU MDR 2017/745 is related to the necessity to document the so-called the clinical development plan.
The requirements for the clinical development plan can be summarised below, reporting the text of the regulation that explains what shall be included in this document :
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.
Clinical Evaluation Plan and Legacy Devices
Thee requirements for clinical evaluation of legacy devices have been further explained within the guideline MDCG 2020-6. We are not going in details over the content of this specific guideline, it is however important to mention that it is generally assumed that legacy devices have already an adequate level of clinical safety properly demonstrated, as these devices are already on the market.
Clinical Evaluation Training
An in-depth online and self-paced training focused on clinical evaluation topics has been developed by QualityMedDev Academy and it is fully available at this link (click in the image below for a full description of the course):
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