Compliance with the regulations valid in the medical device industry
In May 2021 the EU Medical Devices Regulation (MDR) (2017/745/EU) came into effect and replaced the previous Medical Devices Directive (MDD) (93/42/EEC). Regulations on in vitro diagnostic medical devices 98/79/EC (IVDD) have been changed as well, with the more detailed regulation IVDR 2017/746/EU. A new requirement in the regulations is, among others, to share the translated IFU (Instructions For Use) on the manufacturer's website and in the EUDAMED EU database of medical devices. Along with the instructions for use, the following, among others, should be provided as well: information that can be used to determine when a product should not be used any more, details, warnings or precautions to be taken to facilitate safe disposal of the device, and a warning to bring the user’s attention to the need to report a situation when a serious incident occurs in relation to the device.