General Approach to the Medical Device Regulation
The present MDCG guidance is intended to introduce a harmonized approach to clinical evidence as a concept of the medical devices’ regulatory framework.
First of all, the new guidance provides definitions for additional terms that are not defined in the MDR, namely:
- Legacy devices – all medical devices duly marked with the CE mark under the regulatory framework established by the Directives,
- Level of clinical evidence – a concept introduced to describe the amount and quality of evidence, that also includes the level of evidence as one of the integral parts,
- State of the art – developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience (as defined by the IMDRF, the International Medical Devices Regulators Forum, a voluntary association of medical devices regulating authority),
- Intended use – having the same meaning as the “intended purpose” already defined by the MDR.
The guidance describes the general approach to clinical data providing sufficient clinical evidence that is necessary for assessing compliance with the General Safety and Performance Requirements (GSPR) for medical devices already marked with the CE mark under the regulatory framework established by the Directives before the implementation of the MDR. It is also intended to assist medical device manufacturers in compliance with the requirements set forth by the MDR that will substitute the aforementioned Directives. At the same time, the present MDCG guidance covers only general aspects related to clinical evaluation and is not exhaustive.
According to the MDR, compliance with the GSPR should be confirmed by providing clinical data representing clinical evidence sufficient to demonstrate compliance of the medical device in question with the applicable safety and performance requirements. The particular level of clinical evidence used should be justified by the medical device manufacturer, depending on the nature of the device, its intended use, design and characteristics. At the same time, in accordance with Article 61(10) of the MDR, non-clinical data could be also used to demonstrate compliance with the safety and performance requirements, providing that the manufacturer of the device properly justifies the use of such data. It is also important to mention that such approach could not be used in the case of Class III medical devices, and also for implantable ones.
General Aspects of MDCG Clinical Evidence
There is no appropriate definition for “sufficient clinical evidence” in the Regulation 2017/745, while with the term is used in several articles of the aforementioned regulation. To provide additional legal clarity, the MDCG guidance contains the definition of sufficient clinical evidence as the present result of the qualified assessment which has reached the conclusion that the device is safe and achieves the intended benefits. In accordance with this definition, the process of clinical evaluation should include the qualified assessment as an integral part.
It is also mentioned that the requirements for clinical evaluation set forth by the MDR are quite detailed and also cover certain additional aspects. The regulatory approach for clinical evidence utilized by the MDR is based on the following key elements:
- The benefit-risk assessment used to evaluate the alternative treatment options available,
- The acceptability of the benefit-risk ratio,
- The use of not only clinical data but also post-market surveillance data in the process of clinical evaluation in accordance with the PMS plan to be developed and implemented by the manufacturer,
- The implementation of the new definitions for “clinical data” and “equivalence”.
According to the guidance, both pre-market and post-market clinical data initially intended to be used under the regulatory framework established by the Directives, could be also used in the course of conformity assessment under the MDR. Medical devices already placed on the marked (legacy devices) are deemed as ones being properly supported by clinical data since they have already passed the appropriate conformity assessment. At the same time, from the date of the actual MDR implementation, the appropriate requirements for post-market surveillance set forth by the MDR should be applied for the device approved and placed on the market under the Directives during the period of validity of the certificate.
Specific Aspects of Clinical Evaluation
The present MDCG guidance also describes in detail certain specific aspects of clinical evaluation for medical devices already placed on the market under the Directives. In particular, the document provides the following:
- Clinical evaluation plan. The medical device manufacturer shall develop and implement a clinical evaluation plan in order to maintain compliance with the applicable requirements set forth by the MDR. The appropriate plan should cover both pre-market and post-market elements, including the identification of the relevant general safety and performance requirements, specification of the intended purpose of the device, its target groups and indications for use, an information on intended clinical benefits containing the details on the clinical outcome parameters, the details on qualitative and quantitative aspects related to the safety and performance.
- The identification of the clinical data available. According to the guidance, all sources of clinical data should be identified for both the pre-market and post-market phases, including not only the data related to the device in question and provided by its manufactures but also the data generated for the similar device or equivalent properly placed on the market. In accordance with Regulation 2017/745, clinical data is required to demonstrate compliance with the relevant general safety and performance requirements. It is stated that the pre-market sources of clinical data include clinical investigations reports for the device itself and also for equivalent devices, the reports based on the scientific literature, and also other data, such as case reports describing the use of the device. The post-market sources of clinical data include the post-market surveillance clinical data, complaints and adverse events reports, the data generated in the course of additional independent clinical studies, the information from the registries of medical devices, as well as the data from the scientific literature.
- Appraisal of the clinical data. According to the guidance, it is important to evaluate the relative contribution of the particular data sets to the overall clinical evaluation. This includes quality analysis and also the assessment of the level of evidence.
- Generation of new clinical data. For the devices already placed on the market, the new clinical data should be generated in the course of the post-market surveillance procedures in accordance with the appropriate plan developed and implemented by the manufacturer of the device.
- Analysis of the clinical data. It is stated that when confirming compliance with the relevant safety and performance requirements the following points should be taken into consideration:
- The analytical methods used (they should be reliable and justified),
- The results of the comprehensive analysis performed,
- Any missing data and/or any gaps identified.
Summarizing the information provided here above, the present MDCG guidance on clinical evidence describes the general approach to be used by medical device manufacturers and notified bodies when collecting and evaluating the clinical evidence based on the clinical data.
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