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Harmonised standards published

The Commission implementing decision (EU) 2022/15 has been published. It concers harmonised standards for 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 and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and [...]

By | 2022-01-12T11:12:32+00:00 January 12th, 2022|news|0 Comments

Harmonised standards published

The Commission implementing decision (EU) 2022/6 has been published. It concers 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 equipment [...]

By | 2022-01-12T11:07:38+00:00 January 6th, 2022|news|0 Comments

EUDAMED gradual roll-out

Here is the summary of decisions taken : • the UDI/Device module will be released in Production in September 2021. Voluntary use is possible and workable. • the NBs and Certificates module will be released in Production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in [...]

By | 2021-07-09T09:48:52+00:00 July 9th, 2021|news|0 Comments