First lists of harmonized European standards under the European Regulations on MDs and IVDs

The European Commission has published in the Official Journal of the European Union, the list of the first harmonized European standards with presumption of conformity to Regulations (EU) 2017/745 and (EU) 2017/746.

Each list has been published in the form of an implemented decision for each regulation and will be regularly updated according to the standardization work at international and European level.

Implementing Decisions (EU) 2021/1182 and (EU) 2021/1195 enter into force on the day of their publication, July 19 and 20, 2021, respectively.

Read more:

• Harmonized European Standards of Regulation (EU) 2017/745, Implementing Decision (EU) 2021/1182 of 16 July 2021
• Harmonized European standards of Regulation (EU) 2017/746, Implementing Decision (EU) 2021/1195 of 19 July 2021