Within Europe, the regulatory framework for medical equipment is currently the Medical
Devices Regulation (Regulation (EU) 2017/745) which aims “to ensure the safety and performance of medical devices while supporting innovation and maintaining a high level of protection for health”.
This means that medical devices must undergo conformity assessment to show that they meet legal requirements before the CE marking (Conformité Européenne) can be placed on the device and it can be legally marketed. For certain high-risk devices, third party certification by an authorized Notified Body is required.
In order to reduce regulatory burdens on device manufacturers, the EU Commission has now announced proposed changes to the current medical device regulation and also to the In Vitro diagnostic Regulation (EU) 2017/746 (IVDR).
The key proposed changes include simpler rules 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 such as certain laboratory-developed tests used exclusively for clinical trials.
The EU Commission’s press release about the proposed changes can be seen at this link: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077.