Following today’s publication in the Official Journal of the EU, EN ISO 15223-1:2021/A1:2025 is officially harmonised. ISO 15223-1:2021 (Amd. 1:2025) was updated by the International…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations…
EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?
The end of the Mutual Recognition Agreement On May 26, 2022, the new Regulation 2017/746 (IVDR) repealed Directive 98/79/EC on in-vitro diagnostic devices (IVDD), which…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity assessment (MRA) of medical devices started in June 2002 and…