Digital Health Life Sciences

Welcome to Mason Hayes & Curran LLP’s Digital Health Annual Review 2021.

In the six months since the publication of our 2021 Mid-Year Review, advancement in the technology and legal regulation of digital health products shows no signs of slowing. Stakeholders continue to acclimatise to a regulatory environment where the Medical Device Regulation (MDR) is now in full effect.

Although the MDR is doubtlessly the most significant development of 2021 for the EU Digital Health sector, the focus on the regulation of artificial intelligence (AI) and the coming into effect of the In-Vitro Diagnostic Device Regulation (IVDR) continue to loom large on the horizon.

In this Review, we will consider key issues such as:

  • In terms of AI, we set out some important considerations to bear in mind when contracting in this space, as a follow on from our recent White Paper that explores the potentially complex interaction between the proposed AI Regulation and the MDR
  • After a prolonged wait, the MDR became fully applicable on 26 May 2021. We take stock of some recent developments, including the adoption of a number of pieces of implementing legislation as well as the adoption of the first harmonised standards and some more key guidance recently published by the European Medical Devices Co-ordination Group (MDCG), which will be particularly relevant to Digital Health companies
  • Amidst all of these developments and changes, we also pause to consider the present challenges faced by manufacturers of wearable health products operating in such a dynamic regulatory environment, along with issues that are set to emerge over the next few years

As we enter 2022, we discuss these issues and much more arising across the Digital Health landscape in 2021. We hope you enjoy the second edition of our Digital Health Annual Review.

Download your copy of the Review via the link below in Related Downloads.