The MDR (Regulation (EU) 2017/745 of 5 April 2017) requires risks to be acceptable "taking into account the generally acknowledged
Regulation (EU) 2017/745 of 5 April 2017, the MDR, introduced the summary of safety and clinical performance (SSCP) in Article
The MDR (Regulation (EU) 2017/745) was adopted on 5 April 2017 and has applied since 26 May 2021. Article 84
The Medical Device Amendments were signed into law on 28 May 1976. Devices first distributed on or after that date
On 22 December 2025, FDA added AAMI CR515:2025 to its Recognized Consensus Standards database under recognition number 13-153. AAMI TIR45:2023
ISO published ISO 9001:2026 (Edition 6) on 16 September 2026, and ISO 9001:2015 is now listed as withdrawn.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
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