ISO published ISO 9001:2026 (Edition 6) on 16 September 2026, and ISO 9001:2015 is now listed as withdrawn. ISO 13485:2016
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
Cookies help us improve your experience on our website. By using our site, you consent to the use of cookies as described in this policy.
