Clinical Evaluation and Technical Documentation are interrelated in medical devices MDR compliance and both are the back born of the compliance process.
Clinical evaluation is a methodologically sound procedure to collect, appraise and analyze clinical data related to a medical device and to assess there is sufficient clinical evidence to confirm compliance with the general safety and performance requirements of the device when it is used as intended by the manufacturer.
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It is done, initially to obtain CE marking of the device and for placing the device in the market but updated thereafter periodically as new information becomes available from ongoing research works or literature published.
Question 1: Are the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis?
Question 2: the original clinical evaluation of that manufacturer device has been performed in compliance with the requirements of this Regulation. Has the manufacturer of the second device given clear evidence thereof to the notified body?
1. Yes, as per MDR Article 61, clause 5, if a contract is in place between two manufacturers, the subject device manufacturer can have full access to the technical documentation of the other manufacturer on an on-going basis. This is specifically required during the equivalency demonstration.
Some online bloggers have pointed out that this practice is going to be expensive for small-scale manufacturers as the second manufacturer might charge hefty amounts for the contract. This expenditure could be reduced by pooling these small-scale manufacturers (subject devices) followed by signing a contract with the second manufacturer.
2. Yes, as per the same article and clause, it is mandatory that the clinical evaluation of the second manufacturer has to follow the requirements of the MDR and that they should convince the Notified Body with clear evidence. Evidence in this context is the clinical data and results of clinical evaluation pertaining to the device of sufficient quantity and quality to enable the assessment of whether the device is safe, and it achieves the clinical benefits as intended by that manufacturer.
1. I agree with all the explanation given here that a contact is mandatory for subject device’s manufacturer to have full access to the technical documentation of the equivalent device to prove the safety and performance of the subject device but if in case there is no contract between the 2 manufacturers, then publicly available similar device data can be the used with justification for clinical evaluation.
2. I also agree here too that clinical evaluation of the second manufacturer has to be performed under compliance with the MDR requirements and notified body should be convinced with clinical evaluation results and clinical data of sufficient quality and quantity to prove the safety and performance of subject device.