Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct and document a clinical evaluation. As per Article 61(1) MDR, this evaluation should confirm the conformity of the device with relevant general safety and performance requirements under the normal conditions of the device’s intended use. On the other hand, Articles 62 to 80 MDR also set the requirement to conduct a clinical investigation (or clinical study) for manufacturers to demonstrate ongoing device safety and clinical performance requirements. In this sense, several manufacturers struggle to distinguish between a Clinical Study and a Clinical Evaluation Report under the regulation. Therefore, we will assess each document and explain its differences in this post.
What is a Clinical Study?
A Clinical Study or clinical investigation is defined as any systemic investigation or study involving one or more subjects, undertaken to assess the safety or performance of a medical device. In this context, the MDR specifies different types of clinical investigation whose regulatory pathway depends on the Clinical Development Plan and the use of clinical data.
EU competent authorities are heavily involved in the process of clinical investigations. Depending on the nature of the study, an ethics committee opinion is required according to the national law of the country where the clinical investigation is carried out. The ethics committee must approve the clinical study. Likewise, the national competent authority will also evaluate certain type of clinical investigation application and give its approval.
The MDCG issued guidance on clinical investigation application/notification documents and a Q&A guidance on clinical investigation to support manufacturers. Furthermore, information concerning clinical investigations will need to be entered once EUDAMED is fully functional.
What is a Clinical Evaluation?
A Clinical Evaluation can be defined as a set of activities based on scientific methods that assesses and analyses clinical data to verify the safety, clinical performance, and effectiveness of the medical device when the device is used as intended by the manufacturer. Therefore, as stated in Article 61 and Annex XIV of the EU MDR, the Clinical Evaluation shall:
- Identify the intended purpose and associated clinical benefits of the device, including conditions of use and contraindications;
- Establish achievable outcomes with other state of the art for the same patient populations;
- Justify the data sourced used;
- Establish conclusions on:
- Justify the completeness of evidence to support indications, potential patient populations, variants and combinations of the device, etc;
The manufacturer should compile evidence, perform the benefit-risk analysis and document the Clinical or Performance Evaluation and its output in the Clinical Evaluation (MDR) report.
The results of the clinical evaluation and the clinical evidence on which it is based, shall be documented in a clinical evaluation report, which shall support the assessment of the conformity of the device. 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.
The Clinical Evaluation Report shall be based on the Clinical Evaluation Plan, whose content is defined in Annex XIV part A (point 1.a). Thus, as point 4 of the same Annex states:
What other requirements should manufacturers consider?
Manufacturers also need to implement a post-market surveillance system. As part of this, the Post-market Clinical Follow-up (PMCF Plan) is a continuous process integrated into the PMS plan, which:
- Confirms the safety and performance of the device throughout its expected lifetime;
- Identifies previously unknown side-effects and monitors identified ones;
- Identifies and analyses emergent risks;
- Ensures the continued acceptability of the benefit-risk ratio;
- Identifies possible systemic misuse or off-label use of the device;
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