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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

Team-NB Position Paper on “Article 117 – NB Opinion template”

Team-NB members approved a new position paper prepared by the “Article 117” internal task force during the General Assemble Meeting with the intention to provide a template for the opinion of the Notified Body. Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1

By | 2021-10-15T10:18:17+00:00 October 15th, 2021|news|0 Comments