Happy that an ISO standaard for the clinical evaluation of medical devices is progressing. Especially given there is no MDCG guidance available yet apart from the ones for orphan medical devices, equivalence, medical device software, and sufficient evidence for legacy devices. So we are still stuck with MEDDEV 2.7.1 and the IMDRF MDCE WG/N56 for […]
Lees meerhttps://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf By nature ‘orphan devices’ are intended for use in a small number of individuals. This leads to specific challenges for manufacturers and notified bodies on the clinical evidence requirements for the purposes of MDR certification. This MDCG guideline presents guidance on circumstances where it is acceptable to place an orphan device on the market […]
Lees meerTo date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have no intention repeating that, but rather want to focus on the things we CAN do […]
Lees meerHow do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR) applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]
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