On Friday July 12th, 2024, Regulation (UE) 2024/1689 was published in the Official Journal of the European Union (OJEU).
Better known as the “AI Act”, this regulation sets a framework around the development and the distribution of artificial intelligence systems, and applies notably to medical devices.
GMED has been mobilizing its resources for the past months, and created an AI working group, to respond as effectively as possible to these changes in the regulatory and standards landscape. This workgroup is involved in several European standardization committees to follow the evolutions introduced by the AI Act and to comprehend the specific regulatory requirements for the medical field. GMED will thus be able to offer the same level of expertise in supporting the certification of devices integrating AI as for those already within its certification scope.
Article 113 of the new regulation defines the next important dates:
- August 2nd, 2024: date of entry into force
- August 2nd, 2026: effective date for class I medical devices and class A in-vitro devices
- August 2nd, 2027: effective date for high-risk AI systems. This includes the medical devices whose market access must be validated by a notified body conformity assessment.
Until 2027, GMED will continue to certify the medical devices integrating AI under Regulations (EU) 2017/745 and 2017/746.
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