You are here Home Guidance and resources Resources Guidance Refinements to the Personalised Medical Device Framework Guidance to assist sponsors and manufacturers comply with new regulations. Last updated 6 October 2022 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... In July 2021, we undertook a public consultation on Proposed refinements to the personalised medical devices framework. The following refinements have now been agreed: Exclusion of specified products Declaration of some products to be medical devices Contents Exclusion of specified products What is the impact of this instrument? Declaration of some products to be medical devices What is the impact of this instrument? Next steps Supporting documents Refinements to the Personalised Medical Device Framework [PDF, 184.08 KB] Refinements to the Personalised Medical Device Framework [Word, 376.44 KB]