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Monday, January 10th

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New harmonised European standards under Regulation (EU) 2017/745

The European Commission has published in the Official Journal of the European Union the Implementing Decision (EU) 2022/6 which amends the Implementing Decision (EU) 2021/1182 on harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy devices.

This Implementing Decision entered into force on January 5, 2022.

This list will be updated according to the standardization work at international and European level.

DOWNLOAD IMPLEMENTING DECISION (EU) 2022/6

New harmonised European standards under Regulation (EU) 2017/745

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