MEDDEV 2.7/1 Rev. 4 requirements for demonstrating equivalence is more stringent as it is in MDR. Full demonstration of Clinical, Biological and Technical equivalence with respect to medical device characteristics must be performed during Medical Device Clinical Evaluation.
Some key points for manufacturers to consider.
As per latest MDR, for a Class III implantable and few Class IIb device manufactures must have a contract with the owner of the equivalent device for granting permission to access the technical documentation of the equivalent device by applicant ‘s Notified Body. Due to this dilemma to have access to proprietary information of other company, the applicant will need to reconsider different routes for collecting clinical evidence such as Clinical Trials or Post Market Clinical Follow up.
While the MDR does not define parameters for determining equivalence. Guidance document MEDDEV 2.7/1 rev 4 has distinctly identified criteria for evaluation of an equivalent device to be used as clinical evidence. As a result, companies are currently facing the following types of issues from Notified Body review:
- Without serious evaluation addressing all technical, biological, and clinical aspects to claim equivalency.
- Devices not CE Marked are considered as equivalent or similar device for comparison.
- The technology specification is spread across multiple devices.
- Inadequate justification about impact safety or performance characteristics with device in question and equivalent device.