Industry View: EU Plans To Extend Product Liability Rules Bad News For Medtech
A proposed revision to the European Commission’s Product Liability Directive that will extend user compensation eligibility to products such as medical smartphone apps could “needlessly disrupt” innovation in the EU, trade group MedTech Europe warns.
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The provisionally agreed EU’s Product Liability Directive is set to place the burden of proof on medtech companies and extend the latent damage clause from 10 to 25 years. Both updates will have financial and operational impacts on the medtech industry.
While recently proposed amendments to the draft EU legislation on Artificial Intelligence are a step in the right direction for medical devices, trade associations MedTech Europe and COCIR warn that the potential for regulatory conflicts remains.
An expert from the European Union Agency for Cybersecurity (ENISA) has told Medtech Insight that although the new EU Medical Device and IVD Regulations will push developers to make more secure products, regulation is not enough to prevent cyberattacks on devices and digital health systems.