The EU’s proposal for a new Artificial Intelligence (AI) act could upset the regulation and the supply of medical devices. The current proposal comes in addition to medical device legislation. The additional legislation indicates that manufacturers must make sure that their notified body intends to be designated and notified under the AI act, including the new technology codes which may emerge under that legislation. If not, they may have to look for a new or additional notified body.
Notified bodies have inadequate capacity under the EU regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR). The AI act worsens the situation even more and there could be treacherous consequences for the effectiveness of the healthcare system. The deadline for compliance with the IVDR Class D IVD medical devices eligible to benefit from the grace period is 26 May 2025, Class C is 26 May 2026, and Class B and Class A devices placed on the market in a sterile condition is 26 May 2027.
Since the AI regulation could be adopted before the above deadlines, manufacturers who want to continue placing AI-enabled devices on the market have to perform a conformity assessment under the AI act on them, irrespective of whether the AI act’s date of application is before or after the end of the IVDR grace period.
This could bring additional disturbances to an already troubled medical device industry.
Source: Medtech Insight (an Informa product)