July 19th the (EU) COMMISSION DELEGATED REGULATION 2026/1451 entered into force, extending the list of implantable and class III devices exempted from the obligation to perform pre-market clinical investigations. Whereas the list of devices exempted from pre-market studies has been extended, the conformity-assessment framework continues to apply, including the need for a clinical evaluation that:
Lees meer23rd of March 2026 ISO published the new version of ISO 14155. Changes include In other words all involved in medical device clinical trials regardless whether pre-market or post-market, interventional or observational should take note of it. https://www.iso.org/standard/83968.html
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 […]
Lees meer