Healthtech Regulatory

Current issues in Healthtech Finland's Regulatory Affairs groups: AI, Brexit and US emergency use

Wed, 09/23/2020 - 19:33
Regulation serves as a gateway to the healthtech market, both in Finland and elsewhere in Europe and in third countries outside of the EU. The selected market area has direct effects on regulatory strategies and the depth and extent of product development. The September agendas of the Regulatory Affairs groups of Healthtech Finland have now been published!

RA1/software and data: 29 Sept 2020, 10am –12.30pm

  • Case: Top Data Science and examples of AI solutions in the healthtech field
  • Analysis by Cocir of artificial intelligence and its relationship with MD/IVD regulation
  • Opinion of MedTech Europe on AI regulation
  • Schrems judgement and data transfers of personal data to third countries
  • Introduction to the QAiRA toolkit 

RA2/MDR: 29 Sept 2020, 13.30pm –16.30pm

  • Brexit impacts on the export and registration of medical devices in the United Kingdom and the UK Government Communication on “Hard Brexit”
  • Brexit concerns expressed by healthtech companies in Finland
  • US emergency use
  • Introduction to the QAiRA toolkit
  • Current: notified bodies and materials published by the Commission
  • Business presentations: Innokas Medical and Clinipower

The working groups are free of charge and open to all member companies of Healthtech Finland as well as their personnel. 

Interested in participating or suggesting a current topic? Contact:

Sandra Liede, tel. +358 40 700 1658,

Twitter: @sj_liede and @HealthtechFi