The draft statutory instrument for post-market surveillance requirements under the new UKCA regime has been published on the World Trade Organisation website. The notification can be found here. The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 is applicable to Great Britain only. It introduces a new part, Part 4A, which defines the post-market surveillance requirements of…
TeheljJuly 28, 2023