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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017. [ 11 ]
Medical Devices regulations cover all the topics related to the laws, ... 2017/745; Regulation (EU) 2017/746; Regulatory affairs; S. Substance-based medical device; T.
Medical Device Regulation ("MDR") — Regulation (EU) 2017/745 [5] — and in vitro diagnostic Medical Device Regulation — Regulation (EU) 2017/746 [6] — increase obligations of E.A.R in the field of surveillance of medical devices. [5]
Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union; Medical Device Regulation Act of 1976 in the United States
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When Michael Adams was researching health insurance options in 2023, he had one very specific requirement: coverage for prosthetic limbs. The roughly $50,000 leg with the electronically controlled ...