Harmonised standards for medical devices
List of harmonised standards for medical devices
Harmonised standards provide methods to document that devices conform to the essential requirements of the legislation. This means that when these standards are used, a presumption of conformity comes with it.
Use of the standards is voluntary for manufacturers. However, if manufacturers choose not to use the relevant standards, they must document that the essential requirements of the legislation are complied with in some other way.
The below links are to harmonised standards applicable to the medical devices regulation:
Harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
The below link is to the list of harmonised standards applicable to the medical devices directives: