We all expect medical devices to be safe and to incorporate the latest progress in science and manufacturing technology. Since the EU’s rules on the safety and performance of medical devices were laid down in the late 1990s, however, there have been discrepancies in their interpretation across Europe. Issues have also arisen in some categories of medical devices, for instance breast implants and metal-on-metal hip implants.
To reflect progress over the last 20 years, the EU has therefore revised the legal framework. Two new regulations – one on medical devices and the other on in vitro diagnostic medical devices – were adopted by the Council and the Parliament, and entered into force in May 2017.
The new rules will only fully apply after a transitional period. That period lasts for 3 years after the entry into force of the regulation on medical devices MDR (i.e. until May 2020), and 5 years after the entry into force of the regulation on in vitro diagnostic medical devices IVDR (i.e. until May 2022).
The Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by the end of May. This postponement will relief the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. (Source: European Commission).
Health Tuesday invites two Finnish medical companies to tell their stories how they have implemented the essential European regulatory requirements.
8.00 Opening Words
Sampo Sammalisto, Program Manager, Business Finland
8.05 Medical Device Regulations; Startup Perspective
Sakari Soini, CTO, Disior
8.25 Agile co-creation and manufacturing of next generation medical devices - how to ensure the practical application of the regulatory requirements are met throughout the device whole life cycle
Tiina Kotipalo, Head of QA&RA, Innokas Medical
8.45 Questions and Answers
8.55 Closing words
9.00 Health Tuesday event ends
Please find the presentations below: