Starting on May 26th 2021, integrally-combined DDCs will fall under Article 117 of the MDR, which means that compliance of the device component with the applicable General Safety and Performance Requirements (GSPRs, Annex I of MDR) must be demonstrated, prior to submitting the initial Marketing Authorization Application (iMAA) for the DDC.
This new regulation will also have an impact on the life-cycle management of integral DDCs, including those already in the market, especially with regards to substantial changes of the device component.
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👉 Medical Device Regulation (MDR) impact in Pharma Industry: Article 117
📅 28th April 2 p.m. CET (30’ webinar + 15’ Q&A)
👥 Asphalion Medical Device’s expert team