Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devi
A legislative proposal to amend EU regulations on medical devices (2017/745 and 2017/746) to simplify and reduce regulatory burden, amend the EMA support regulation (2022/123), and update the AI Act (2024/1689) regarding the list of Union harmonisation legislation in its Annex I. The proposal is not yet in force and touches the AI Act among other monitored acts.
What changed
- Amendment to Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices to simplify and reduce regulatory burden
- Amendment to Regulation (EU) 2022/123 regarding EMA support for expert panels on medical devices
- Amendment to Regulation (EU) 2024/1689 (AI Act) regarding the list of Union harmonisation legislation in Annex I
Who is affected
Manufacturers and distributors of medical devices and in vitro diagnostic medical devices; the European Medicines Agency; organizations subject to AI Act requirements
- Language
- EN