AI in medical devices

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AI in medical devices

How to approach the regulatory “octopus” entangling any new medtech product? Instead of just citing the regulations, we decided to share a hypothetical case study. We answer more than 30 questions from four key areas, but surely this does not exhaust the potential legal issues in this area.

Technology is changing medicine before our eyes—paradoxically, largely due to the Covid-19 pandemic.

On the macro scale, this is one of the pillars for restoring the competitiveness of Europe and Poland on the global market. On the micro scale, this is happening thanks to bold companies, especially medtech and biotech companies, developing innovative solutions and bringing them to the market, creating completely new opportunities in the areas of diagnostics, treatment, and functioning of the healthcare system.

The legal environment in this area is dynamic, and legal challenges are constantly mounting, from regulatory matters (compliance with the Medical Device Regulation and the AI Act) to protection of medical data and intellectual property issues.

Lawyers from the firm’s Life Sciences and Healthcare, New Technologies, Data Protection and Intellectual Property practices write about how to approach the subject.