A number of technical standards have been updated during the last months. Some of them with the objective of addressing the requirements of MDR 2017/745 – especially fulfilling the GSPR (Annex I). The latest list of these so-called harmonised standards is available here: https://ec.europa.eu/docsroom/documents/58477
The application of harmonised standards for implementation of GSPR requirements allows presumption of conformity. Harmonised standards should therefore also be applied if previous versions are still valid based on transitional regulations.
The implementation naturally needs to be prioritised. A gap analysis should therefore be carried out between the harmonised standard and the previous version as well as a synchronisation with the affected GSPRs. On this basis, the necessary measures and their implementation priority can accordingly be determined.
In general, it should be noted that not each GSPR requirement can be fully covered by a single harmonised standard. Many GSPR requirements need to be covered by several harmonised standards or even by a combination of harmonised, non-harmonised standards and/or common specifications. In addition, the harmonisation of technical standards with the requirements of MDR 2017/745 has not yet been completed. Therefore, the list of harmonised standards will continue to expand in the future.
