What is a Clinical Evaluation?
As per the EU MDR, a Clinical evaluation “means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer”.
There is increased importance, focus and scope with clinical evaluations. Manufacturers must identify and rationalise the level of clinical evidence needed to demonstrate conformity with the relevant general safety and performance requirements as per Annex I of the MDR and must plan, conduct, and document a clinical evaluation in accordance with Article 61 and part A of Annex XIV.
Clinical evaluation is a continuous process completed throughout the entire lifecycle of a medical device and all manufacturers are obliged to perform them. They are part of medical device development and demonstrate compliance to attain approval and become CE marked. Clinical evaluation conclusions are documented in a Clinical Evaluation Report (CER). It consists of analysed clinical data gathered either from clinical investigations of the device, and/or results of other studies on considerably equivalent devices.
The CER demonstrates that the device achieves its intended purpose without subjecting users and patients to further risks. CERs are required for all medical devices in Europe and must be submitted to the designated Notified Body as part of the European CE Technical File. EU MDR has imposed stricter requirements for CERs, such as the basis of establishing an equivalence with another device and the quality of data considered in the clinical evaluation.
Clinical evaluations must also include a continuous clinical follow-up of the medical device in the market referred to as a Post-Market-Clinical-Follow-Up, (PMCF) which should be performed in accordance with the requirements set out in Article 61 and Annex XIV. Manufacturers should collate and assess clinical data from the use of the device in the market with the intention of confirming safety and performance whilst ensuring the continued acceptability of identified risks and any potential emerging risks based on factual data.
There are many plans, reports and documents that a manufacturer must consider and maintain and can include the following with guidance located here:
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation report (CER)
- Post Market Clinical Follow-up (PMCF)
- Clinical Follow-Up Report for Class I devices as part of PMS
- A plan for clinical investigations as part of PMCF or rationale why it may not be applicable.
- Periodic Safety Update Report (PSUR) for Class IIa, Class IIb and Class III devices
- PMCF Evaluation Report with annual updates for Class IIIa and implantable devices
- Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices
- Clinical Evaluation Assessment Report (CEAR) prepared by the Notified Body.
Clinical evaluations can vary considerably, however, the result should be the same. It should include appropriate detail to understand the data, analysis and conclusions achieved to demonstrate device safety. In summary and as per the EU MDR, all manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. This is placing a greater duty upon manufacturers and their representatives and can be a major challenge. This is where Med-Di-Dia can help.
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- Main Blog
- Factors to keep in mind preparing for Clinical Evaluation.
- Steps by Step guide for Clinical Evaluation reporting – Medical Devices in the European Union
- Clinical Evaluations and Challenges