European Commission, Implementing Regulation, Single-Use Medical Devices – Safety and Performance Requirements for Reprocessing (2019)

European Commission, Implementing Regulation, Single-Use Medical Devices – Safety and Performance Requirements for Reprocessing (2019)

“…Regulation (EU) 2017/745 allows reprocessing of single-use devices only where it is permitted by national law. As regards single-use devices that are reprocessed and used within a health institution, Regulation (EU) 2017/745 allows Member States not to apply all of the rules relating to manufacturers’ obligations laid down in that Regulation. One of the conditions for such reprocessing is that it is performed in accordance with common specifications (‘CS’).”

https://ec.europa.eu/info/law/better-regulation/initiative/11888/publication/5715706/attachment/090166e5c601ed28_en

By |2019-09-07T01:17:51+00:00September 7th, 2019|Global Regulatory Resource|0 Comments