16.08.2022
To the attention of all parties interested in devices without an intended medical purpose
Please be advised that the final draft of the Implementing Regulation on reclassification of the groups of active products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, was posted on the European Commission website, DG SANTE: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
All those interested may send comments until 8 September 2022.