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Harmonised standard list for process standards Exploring the Harmonised Standards List MDR IVDR Our objective with the Harmonised Standards List MDR IVDR is to provide you with an in-depth overview of both the current status and the anticipated future updates. We have meticulously curated this list by aligning it with the MDR and IVDR requirements and the Commission’s harmonisation plan. However, it’s important to note that the harmonised standards list is a work in progress, as elaborated below. The Standard Harmonization Plans Mandate M/575 - C(2021)2406 : 2021-03-12 M/575 Amd 1 – C(2023)694 We have devoted significant effort to ensure the accuracy of this list, although its creation involves meticulous manual work. If you happen to spot any errors, we would greatly appreciate your feedback so that we can make the necessary corrections. We extend our gratitude to SWITEC and SNV for their invaluable expert contributions. Publications in the Official Journal Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council Amendment of 4 January 2022 to Implementing Decision (EU) 2021/1182 Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1182 Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1182 Amendment of 6 March 2024 to Implementing Decision (EU) 2021/1182