Category - Artificial Intelligence

medicaldeviceslegal

The New Product Liability Directive(s) proposals and medical devices / IVDs

On 28 September the Commission adopted two related proposals for EU regulation of no-fault liability for defective products. One proposal updates the ‘old’ Product Liability Directive (PLD) from 1985 to make it suitable again for the current circumstances. The other proposal provides a complimentary directive for liability specifically for damage caused by AI. You can […]

medicaldeviceslegal

The new EU AI regulation proposal, medical devices and IVDs

Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I, section 17 MDR and Annex I, section 16 IVDR, the Commission proposes new mandatory regulation to supplement the the MDR and the IVDR […]