Delegated Regulation (EU) 2026/1359 and Delegated Regulation (EU) 2026/1451

29-June-26

We would like to bring to your attention an important regulatory development under the Medical Device Regulation (EU) 2017/745 (MDR). On 29 June 2025, two Commission Delegated Regulations were published in the Official Journal of the European Union:

Delegated Regulation (EU) 2026/1359 - Art.52(4) - expanding the list of Class IIb implantable devices exempt from the requirement to perform an assessment of the technical documentation for every device.
Delegated Regulation (EU) 2026/1451 - Art.61(6) point (b) - expanding the list of implantable devices and Class III devices exempt from the requirement to perform clinical investigations.

The Regulations will enter into force 20 days after publication.

Access the full News article for further information.