PMG members may be interested in MHRA’s work on “In House Manufacturing” guidance related to medical devices and in vitro diagnostic medical devices under the Medical Device and In Vitro Medical Device Regulations (IVDR/MDR).

MHRA is now seeking stakeholders’ views on this draft guidance (Health institution exemption for IVDR/MDR) covering the requirements for health institutions under the Medical Devices Regulations.

The deadline for comments is 31st of March 2019.

Please consider the proposal and respond in ways indicated in the consultation webpage, available here.