New MHRA Guidance concerning extended periods of validity of CE Certificates and Declarations of Conformity for some in vitro diagnostic medical devices
MHRA, Single Use, In vitro diagnostic Medical Devices Elisabethann Wright MHRA, Single Use, In vitro diagnostic Medical Devices Elisabethann Wright

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

Reflecting the 2024 revisions to the EU in vitro diagnostic Medical Devices Regulation, the UK MHRA has published a legislation extending acceptance of CE-marked in vitro diagnostic medical devices (IVDs) on the Great Britain (GB) market (Registration of certain in vitro diagnostic devices - GOV.UK).

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Commission Implementing Decision on harmonized standards for medical gloves for single use
Medical Devices, Single Use Elisabethann Wright Medical Devices, Single Use Elisabethann Wright

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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