The Official Journal of the European Union L 090I, Volume 63, dated 25 March 2020 includes a new list of harmonized Standards for:
- 93/42/EEC Medical Device Directive
- 90/385/EEC Active Implantable Medical Devices
- 98/79/EEC In-Vitro Diagnostic Directive
but these standards are NOT intended to be used for the MDR! The official wording is:
Article 3:
The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745.
New standards are:
- EN ISO 10993-11:2018,
- EN ISO 11137-1:2015/A2:2019
- EN 11608-7:2017,
- EN ISO 11990:2018,
- EN ISO 13408-2:2018
- EN ISO 13485:2016/AC:2018
- EN 13795-1:2019,
- EN 13795-2:2019
- EN 13976-2:2018,
- EN 14683:2019+AC:2019
- EN ISO 15747:2019.
- EN ISO 15883-4:2018,
- EN ISO 17664:2017
- EN ISO 21987:2017
- EN ISO 25424:2019
- EN ISO 81060-2:2019