The Commission of the European Union (EU) has announced proposed changes to its current medical device and in vitro diagnostic regulations that would reduce regulatory burdens on device manufacturers.
According to an article posted on the Commission’s website, the key changes include simpler rules for medical devices and revised timelines for conformity assessments to help support more efficient access to new devices. The Commission says that the changes are intended to address “unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients.”
A key change would positively impact how medical devices that integrate artificial intelligence (AI) technologies are regulated by limiting the scope of requirements under the EU’s AI Act that apply to devices. The proposed changes would also reduce risk classifications for certain reusable devices or instruments, while also exempting from some requirements certain laboratory-developed tests used exclusively for clinical trials.
The EU Commission’s press release on its proposed changes to its medical device regulations is available at https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077.