The MDR (Regulation (EU) 2017/745) was adopted on 5 April 2017 and has applied since 26 May 2021. Article 84
On 22 December 2025, FDA added AAMI CR515:2025 to its Recognized Consensus Standards database under recognition number 13-153. AAMI TIR45:2023
The Clinical Evaluation Report (CER) became a required part of European Union medical-device technical documentation under Regulation (EU) 2017/745, adopted
Free sale certification has changed on both sides of the Atlantic. Since 2 January 2024, FDA's Center for Devices and
The investigational device exemption (IDE) is the framework that allows an unapproved device to be used in a clinical investigation
For medical devices, an FDA adverse event report is a Medical Device Report (MDR) under 21 CFR Part 803. The
Manufacturers have been able to register in EUDAMED, the European database on medical devices, since December 2020 for the Actor
Post market surveillance (PMS) for medical devices is the system a manufacturer uses to collect and analyse data on its
A new development in healthcare cybersecurity is the publication of IEC TS 81001-2-2:2025, which provides updated guidance on the implementation,
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