The Clinical Evaluation Report (CER) became a required part of European Union medical-device technical documentation under Regulation (EU) 2017/745, adopted
The IVDR was adopted on 5 April 2017 and has applied since 26 May 2022 (Regulation (EU) 2017/746). In December
Free sale certification has changed on both sides of the Atlantic. Since 2 January 2024, FDA's Center for Devices and
The AI Act, Regulation (EU) 2024/1689, was adopted on 13 June 2024 and applies generally from 2 August 2026. Regulation
The investigational device exemption (IDE) is the framework that allows an unapproved device to be used in a clinical investigation
A Form FDA 483 and an FDA Warning Letter are not the same document. A 483 lists the investigator's observations
For medical devices, an FDA adverse event report is a Medical Device Report (MDR) under 21 CFR Part 803. The
A De Novo review is FDA's risk-based classification route for a novel device that has no legally marketed predicate, but
Device listing is the part of FDA registration that most teams touch once a year and otherwise forget. That is
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