Two MDR delegated regulations on well-established technologies (WET) published in the Official Journal

Published: 29 Jun 2026

Delegated Regulations (EU) 2026/1451 and 2026/1359 amend MDR 2017/745 to expand the list of well-established technology devices, covering implantable and class III devices exempt from clinical investigations, and class IIb implantable devices exempt from technical documentation assessment for every device. The newsletter states they enter into force 20 days after publication; manufacturers of listed devices may benefit from reduced requirements, while others need not act.

Original title: Medical Devices: Delegated acts on well-established technologies published

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