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Medtech Industry Says Latest EU AI Act Revisions Insufficient As Questions Remain

 
• By Eliza Slawther

Recent revisions to the European Commission’s proposed AI Act have failed to resolve uncertainties around its interaction with medtech regulations, leaving crucial parts of the legislation open to interpretation. Industry representatives have said further steps must be taken.

Unclear
• Source: Shutterstock

The EU Council adopted its common position on the draft Artificial Intelligence (AI) Act on 6 December, representing a nudge closer to the adoption of the new horizontal regulation across the EU.

Although revisions have been made to the latest version of the AI Act, the potential for misinterpretation in the context of its impact on medtech is

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• By Amanda Maxwell

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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

More from Geography

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.