Commission Implementing Decision on harmonized standards for medical gloves for single use

A European Commission Implementing Decision has amended and expanded Implementing Decision (EU) 2021/1195 as regards harmonized standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances. Compliance with this harmonized standard confers a presumption of conformity with the corresponding essential requirements set out in the Medical Device Regulation.

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New MHRA Guidance concerning extended periods of validity of CE Certificates and Declarations of Conformity for some in vitro diagnostic medical devices

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The European Court of Justice clarifies different definitions of a medicinal product and a medical device