MedTech Europe has now been calling for the urgent clarification of a proposed regulation of artificial intelligence because it has been using an overly broad definition and it is also misaligned with all the existing regulatory frameworks.
The European Commission has also outlined that, it is now planning to regulate the artificial intelligence technology, which is including the medical devices and in the vitro diagnostics, that have been featuring the artificial intelligence technology.
Under the proposal, the European Union is also going to require the high-risk artificial intelligence systems for the purpose of complying with the certain compulsory requirements before it will be launched into the market, and the European Commission has also been acknowledged by a risk for overlapping with the already existing regulations, but it has also envisioned the framework for the purpose of complementing the requirements like the Medical Devices Regulation.
Although, MedTech Europe have been maintaining the proposal falling short of the vision, and while giving the feedback to the European Commission, the medtech trade group of the European Union has also highlighted multiple examples for the perceived misalignment between the Artificial Intelligence Act (AIA), IVDR and MDR, and the MedTech Europe is seeing the misalignments are going to have some serious consequences.
MedTech Europe said, there had been concerns that, the Artificial Intelligence Act (AIA) is going to be responsible for creating the need for the manufacturers for undertaking the duplicate certificate or conformity assessment through the two bodies along with maintaining the two sets of the technical documentation.