Dive Brief:

• MedTech Europe has joined with trade groups representing other manufacturing industries to warn that the Artificial Intelligence Act could have a “significant impact” on companies that are already under “regulatory strain.” 
• The trade group is concerned that “overregulation and misalignment” could create uncertainty and stop products from coming to market. 
• The organization, noting that the AI Act may impose “technical and financial burdens” and exacerbate notified body capacity constraints, is calling for changes to align the proposal with the existing New Legislative Framework (NLF).

Dive Insight:

The NLF is a cross-industry set of measures intended to improve market surveillance and the quality of conformity assessments. According to the trade groups, the AI Act modifies fundamental parts of the NLF, such as its definition of “economic operator,” and lacks a clear definition of “risk,” a key factor in conformity assessments. 

While the trade groups support incorporating NLF concepts into the AI Act, they want the extra layer of AI-specific requirements to be consistent with the existing text. MedTech Europe and its counterparts are worried about the impact of the current proposal. 

“Changing NLF concepts would only result in regulatory distortion and misapplication of baseline requirements for manufacturers, exacerbating already existing economic and administrative burdens on Member States and responsible national authorities, but most importantly, adversely impacting European citizens,” the trade groups wrote.

The potential issues stem from the fact that the AI Act will apply to products that are already regulated under legislation such as the Medical Devices Regulation and the In Vitro Diagnostic Regulation. As such, the trade groups want legislators to “be aware of the NLF concepts and the evolution of sector-specific concepts when negotiating legislative proposals to ensure consistency and alignment.”

Specifically, MedTech Europe wants the AI Act to respect specifications such as what qualifies as a “substantial modification.” The trade groups also want quality management systems for AI to be integrated and compatible with existing product-level systems.