Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography. The objective behind clinical evaluation of medical devices is to ensure patient/user safety, drive manufacturers and Notified Bodies (NBs) towards evidence-based decision-making, and at the same time inform them about Post-marketing Surveillance (PMS) activities.
Manufacturers are required to deduce and formulate a Clinical Evaluation Report (CER) based on the clinical evaluation process, which is further updated throughout the product’s lifecycle and submitted to the respective NB periodically, depending upon the risk classification of the device.
The very first step in the clinical evaluation process is the Clinical Evaluation Plan (CEP). The CEP is part of the technical documentation and is submitted at the time of the initial application for Regulatory approval. It plays a critical role since it acts as a skeletal framework for the clinical evaluation process and the report. It provides a clear, detailed picture of the entire process to the NBs, in terms of the methodology, the gathering of the clinical evaluation data, data sources, etc. Article 61 (12) and Part A of Annex XIV under EU Medical Devices Regulations (MDR) 2017/745 lay out a detailed explanation of the requirements for CEP. A CEP should include information on the following aspects: -
- Identification of general safety and performance requirements (as per Annex I of EU MDR 2017/745), which requires data support from clinical evaluation.
- Specification of the intended purpose.
- A distinct clarity with respect to the specification of the target group, with clear indications and contraindications.
- Detailed description of the intended clinical benefits to patients.
- Methods of examination of the qualitative and quantitative aspects of clinical safety.
- Indication of how the risk-benefit ratio to a specific component is to be addressed.
- Clinical development plan, which includes information on the clinical investigation plan; this helps reach conclusions about the safety and clinical performance of the device and its clinical benefits.
- Analysis of Post-market Clinical Follow-up (PMCF) requirements.
Much like the CER, the CEP also needs to be updated periodically or as and when required. This ensures that the safety and performance of the device remain intact and in line with the EU MDR 2017/745, even as new information becomes available via PMS, clinical investigations, and other sources. Thus, while updating the CEP for devices that are already CE marked, some of the key aspects that should not be overlooked are:
- Any changes in device design and functionality, addition of new intended uses, claims, equivalence, etc.
- Any additional specific clinical concerns that need to be addressed.
- Updating PMS activities in accordance with new clinical data available for the device under evaluation and/or equivalent device, new knowledge of concerns or hazards, performance, benefits, and claims.
One the one hand, drawing up a CEP can be a daunting task, while on the other, it plays a critical role in the entire Regulatory approval process for the EU region. Keeping a close eye on the information included in the CEP is of immense importance, and hence requires specific Regulatory knowledge and expertise.
Freyr can help you navigate through the Regulatory complexities and produce a high-quality CEP. Schedule your appointment with us today. Stay informed! Stay compliant!