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Welcome to Mason Hayes & Curran LLP’s Digital Health Mid-Year Review 2021.

In the six months since publication of our 2020 Annual Review, regulatory developments in the digital health sector have continued apace.

Throughout the first half of 2021, we have seen:

  • An increased focus on the proposed regulation of artificial intelligence (AI)

  • The coming into force of the Medical Devices Regulation (MDR) on 26 May 2021

  • Further guidance published by the European Medical Devices Co-ordination Group (MDCG), and

  • Continuing preparations for the coming into force of the In-vitro Medical Devices Regulation (IVDR) on 26 May 2022

We look at these important developments and draw out the key issues for stakeholders to be aware of.

We also consider issues such as:

  • The EU Digital COVID Certificate

  • Key challenges for the application of AI in the medical device sector and how regulators and policy makers are responding

  • The regulation of mental well-being apps, and

  • Recent developments on a proposed EU Health Technology Assessment Regulation

We hope you enjoy the second edition of our Digital Health Mid-Year Review.

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