Clarification of terminology for combination products (medicinal products with a medical device component) – Current status and revision of specification documents

16. Dezember 2022 – The new Regulation (EU) 2017/745 on medical devices (MDR) has been in effect since 26 May 2021. In its publication dated 26 May 2021, Swissmedic provided information on the new requirements for combination products. For practical implementation of Art. 117 MDR, Swissmedic refers to the EMA's “Guideline on quality documentation for medicinal products when used with a medical device” (EMA/CHMP/QWP/BWP/259165/2019). A revised version of this was published on 22 July 2021. Revised versions of Swissmedic's specification documents are also now available.

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