Health Tuesday is a series of networking events addressing topical health and wellbeing themes, usually organized on the first Tuesday of each month. Health Tuesday offers participants an excellent opportunity to discuss with professionals of health, well-being and health tech companies, decision makers, investors and representatives of the public sector. Oulu takes part in Health Tuesday events via webcast. However, in May this event will not be streamed. 

Next Health Tuesday will be held online as a Teams meeting and there will be no separate local program.

Health Tuesday: New European medical devices regulation

Time: 5 May 2020
Place: Teams meeting

Medical devices are expected 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 relieve the pressure of national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. (Source: European Comission).

Health Tuesday invites two Finnish medical companies to tell their stories about how they have implemented the essential European regulatory requirements.  

Find out more information and register via the event webpage.

 

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