MHRA Guidelines: Navigating Borderline Products
MHRA Determining Medical Device Status and Appropriate Risk Classification
Determining Medical Device Status and Appropriate Risk Classification
This guide provided by the Medicines and Healthcare products Regulatory Agency (MHRA) delves into the intricacies of borderline products. It sheds light on the process of discerning whether a product qualifies as a medical device and outlines the criteria for assigning the appropriate risk class to such devices.
Insight into MHRA Decision-Making
The document elaborates on the rigorous decision-making process undertaken by the MHRA when evaluating products that straddle the boundary of medical device classification. By offering transparency into these evaluations, it aims to provide manufacturers and stakeholders with clarity regarding the regulatory status of their products.
This information is current as of the 11th of July, 2023, ensuring that you are equipped with the latest guidance to navigate the complex landscape of medical device classification and risk assessment.