2022 12 19 | FDA
FDA has recognized IEC 81001-5-1 Edition 1.0 2021-12
Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle. Recognition Number 13-122
2023 03 20 | MDR IVDR
Regulation (EU) 2023/607 was adopted in Europe. The new regulation allows legacy medical devices that fulfill the additional conditions of Article 120 (as amended) to remain in the market till 2027/2028, depending on the class of the devices according to the Medical Devices Regulation (EU) 2017/745 (MDR).
2024 08 13 | AI Act
13 June 2024, Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence) provides AI developers and deployers with clear requirements and obligations regarding specific uses of AI. At the same time, the regulation seeks to reduce administrative and financial burdens for business, in particular small and medium-sized enterprises (SMEs).
August 1, 2026: Many of the law’s obligations kick in on this date (the “Application Date”)
2024 08 13 | NIS2
14 December 2022, Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive)
By 17 October 2024, Member States must adopt and publish the measures necessary to comply with the NIS 2 Directive.