EU: new Regulations
On 15th December 2021, the new Commission Implementing Regulation (EU) 2021 / 2226 on electronic instructions for use of Medical Devices (eIFU) has been published on the Official Journal of the European Union. This Regulation repeals the previous Commission Regulation 207/2012 adapting to MDR (EU) 2017/745 requirements. However, the Commission Regulation (EU) 207/2012 still applies …