https://health.ec.europa.eu/latest-updates/commission-proposes-extend-transition-periods-certain-ivds-gradual-roll-out-eudamed-and-information-2024-01-23_en
Lees meerhttps://health.ec.europa.eu/system/files/2023-12/mdcg_2023-7_en.pdf Among other things it explains that for class III and implantable devices Thereby giving room to device manufacturers to save time and money in their CE-marking process.
Lees meerThe guidance does not intend to address the typical clinical evaluation aspects, for that it refers to MDCG 2020-1, but does emphasize that For option 1 and 2 MDSW* “the MDSW manufacturer must verify, validate and demonstrate the safety, reproducibility, compatibility and interoperability of the medical device or accessory to a medical device that the […]
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