The European Union (EU)'s new regulatory framework of the Medical Device Regulation (MDR) came into force today, and the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) has offered a review of the rules in a position paper.
One important aspect is that medical devices must comply with a plethora of other EU legislation, according to the COCIR. Current discussions on cybersecurity requirements under the Radio Equipment Directive or the future Artificial Intelligence Act highlight how the complexity of various regulations requires constant vigilance to avoid duplications and unnecessary burden on manufacturers, it says.
The barriers to the harmonization of standards are another example of the impact of horizontal EU action on the placing on the market of medical devices.
For more details on the paper, go to the COCIR website.
