Before obtaining CE Marking for medical devices in the EU, medical device manufacturers must prove to the competent authority that their device meets safety and performance standards and hence, the EU MDR requires the clinical evaluation of their device. Clinical evaluation is a required for all the medical devices regardless of the classification of device.
According to EU MDR – “Clinical Evaluation means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a medical device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer”.
Is the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements?
In this situation, it is essential for notified body to verify the PMCF plan is suitable which incorporates the post market studies to establish the performance cum safety of the device.
Additionally with obedience to above stated, there is no prerequisite to carry out the clinical investigation by the manufacturer of the device which has exhibited equivalence to the marketed device which is already marketed and not manufactured by them fulfilling below requirements:
– Manufacturer of the existing marketed device has complete access to official documentation on continuous basis with comprehensive contractual agreement in place.
– Clinical assessment of marketed device has been done in accordance and compliance to the
MDR [Medical device regulation] requirements and the manufacturer of the second device produces the necessary proof thereof to acquainted body.
And also in some cases as per the Article 61, chapter VI for all devices of class III and II b, the manufacturers are allowed to consult an expert panel prior to clinical evaluation / investigation for reviewing the intended clinical development plan and proposals. The manufacturer will consider the views stated by the expert panel and same will be documented in the clinical evaluation report.
Yes, the clinical evaluation of the marketed device is sufficient to demonstrate the conformity of the modified device with the relevant safety and performance requirements, provided the following conditions are maintained:
• There should not be any major design changes so that the intended purpose or the mechanism of action differs from that of the marketed device.
• There should not be any changes to the materials and manufacturing procedures
• There should not be any changes to the information materials (labels or IFU or brochures) or other claims
• There should not be any changes to the claims of the equivalence to an existing device
Alternatively, if there are any changes in the above-said conditions, for the CE-marked devices, it should be reflected in their Clinical Evaluation Plan, the CER as well as in the PMS activities.
Yes, I agree with the above comment.
Most of the modified devices cannot be considered to be novel since the modifications are done in increments. Therefore it is possible to establish its conformity to safety and performance requirements by using the clinical evaluation of the marketed device as long as there are no major changes in the design, manufacturing process, information materials and claims of equivalency to an existing device.
Clinical evaluation of marketed device would suffice to prove the safety and performance of modified device for the purpose of CE marking, if marketed by same manufacturer without any major changes in device design, material and manufacturing process, IFU, labels, equivalency claims.
If still there is any gap to fulfill the EU MDR requirements, proper justification should be provided with post marketing data and PMCF.