Medical device regulation brings new requirements for clinical evaluation
After postponing the implementation for a year, the EU’s medical device regulation (MDR) will replace the current medical device directive (MDD) and active implantable medical device directive (AIMDD) on May 26, 2021.
After the due date, new devices and devices without a valid MDD/AIMDD certificate will have to meet the new requirements. For devices with valid MDD/AIMDD certification, the 3-year transition period lasts until the 26th of May 2024. The MDR also brings new medical devices into the scope of the regulation.
Consequences for clinical evaluation of medical devices
All medical devices need a clinical evaluation, and now the rule for claiming equivalence is stricter than during time with MDD. Manufacturers need to have sufficient levels of access to the data relating to devices whereby they are claiming equivalence.
According to MDD “manufacturers shall plan, conduct and document a clinical evaluation”. Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data on a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use. Manufacturers of class III devices (e.g. implantable devices) need to conduct a clinical investigation.
The safety and performance of the device need to be based on sufficient clinical evidence. This means the confirmation of conformity with relevant general safety and performance requirements, the evaluation of the undesirable side effects, and evaluation of the acceptability of the benefit–risk ratio. The results of the clinical evaluation and the clinical evidence on which it is based, shall be documented in a clinical evaluation report. The target of the report is to support the assessment of the conformity of the device.
However, the clinical evaluation does not end for receiving the CE-mark for the medical device. Clinical evaluation and its documentation are an ongoing process and it shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s post-market follow-up (PMCF) plan. In the PMCF plan, the manufacturer decides the update rule for clinical evaluation report based on new clinical data acquired during PMCF studies or post-market surveillance reports.
Five main points about MDR and clinical evaluation
- Devices with non-medical purposes, e.g. contact lenses, products for cleaning, disinfection or sterilization, fall under the medical device regulation.
- Claiming equivalence to another device is tightened.
- Manufacturers of class III devices (e.g. implantable devices) need to conduct a clinical investigation.
- After receiving CE-mark, the manufacturer needs to proactively collect and evaluate post-market clinical follow-up data and post-market surveillance data.
- Clinical evaluation of the device needs to be updated regularly throughout the lifetime of the device.
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