RegDesk Regulatory Roundup

MHRA on borderline products Europe

MHRA on borderline products

The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...

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MHRA on MD registration (overview) Europe

MHRA on MD registration (overview)

The article provides a brief overview of the way medical devices should be registered when placed on the UK market. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has...

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