Why are clinical activities required?
The clinical evaluation is a critical process for a medical device manufacturer who needs to gather all available clinical evidence with the purpose to demonstrate the safety and performance of the device as well as the favorable benefit / risk profile.
Per article 61 and Annex XIV of the (EU) 2017/745, Medical Devices Regulation (MDR), a manufacturer needs to confirm the conformity with relevant general safety and performance requirement (GSPR) based on sufficient clinical data. The sufficiency of clinical data depends on the device type and classification, and requires to be justified per MDCG 2020-6. When no sufficient clinical evidence is available for a specific device, a manufacturer may decide to rely on clinical data specific to devices demonstrated as equivalent. However, the equivalence can only be used under certain circumstances and shall be strongly justified per MDCG 2020-5. The second option for a manufacturer is the implementation of a clinical investigation to collect human data on patients before device commercialization.
The clinical evaluation process starts with a clinical evaluation plan (CEP) that delineates the scope of the evaluation, the clinical development plan, the methods, specifications and parameters to determine the safety, performance and benefit/risk ratio based on the state of the art for the medical conditions treated or diagnosed by the device.
The implementation of the CEP results in the issuance of the clinical evaluation report (CER) that documents the methodological sound procedure implemented to collect favorable and unfavorable data on the device via the scientific literature, clinical investigations, post-market clinical follow-up (PMCF) activities, post-market surveillance (PMS) activities or preclinical data. Generally, a clinical data search protocol is established per the MEDDEV 2.7/1 rev.4 to search literature articles, vigilance, recalls in the (publicly) available databases. The protocol will also result in one or several reports to document the search methodology carried out and results obtained. The process is highly regulated and deviations, lack of justifications, inconsistencies can generate questions from your reviewer who will not trust in the comprehensiveness of data discussed. The MDR requires the clinical evaluation process to be implemented by qualified evaluators with a sufficient background and experience.
For specific products, such as class III or class IIb implantable devices, additional obligations have to be met regarding the need of clinical investigations or constraints to use an equivalent device. In addition, for all class III and implantable devices, a SSCP must be generated using the outputs from CER, Periodic Safety Update Report (PSUR) and PMCF evaluation report. The SSCP needs to be defined using the template and requirements delineated in MDCG 2019-9 and will be publicly available.
