A trust that I have worked with for some time intends on supplying procedure packs (Article 22) and supplementary items to health clinics and would then be considered as placing devices on the market. We are now unable to use Article 5.5 of the MDR and would be considered as the legal manufacturer. The Trust is ISO13485 accredited and also to Article 12 of the MDD. Can anyone clarify the extent to which the MDR or similar UK adopted regulation, would apply in terms of Technical Files, UDI and PMS? Thanks in advance