The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect necessary safety data to support the relevant claims included in the premarket submission.
RegDesk Regulatory Roundup
The article addresses specific aspects to be taken into consideration concerning premarket submissions for orthopedic devices with metallic or calcium phosphate coating, including the ones related to clinical testing, labeling, and modifications.
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
The article provides a general overview of the regulatory concepts associated with demonstrating substantial equivalence for specific products intended to be marketed and used in the EU.