somes

Transitional Provisions for In Vitro Diagnostics and In-house Devices

Summary

This regulation extends transitional periods for certain in vitro diagnostic medical devices and delays the application of requirements for in-house manufactured devices to prevent supply shortages.
9 14.02.2022
Other
health
european union
administrative law

Key points

  • Extension of transitional periods for specific in vitro diagnostic medical devices currently on the market.
  • Deferral of the application of stricter requirements for 'in-house' medical devices produced within healthcare institutions.
  • Mitigation of potential supply shortages for essential medical diagnostic tests.
  • Provision of additional time for manufacturers and healthcare providers to comply with updated EU safety regulations.

Speeches

1 Speech in total

Pro
Contra
Roberta METSOLA
Roberta METSOLA
PPE
0:24 min
11. Signing of acts adopted in accordance with the ordinary legislative procedure (Rule 79)
Documents (PDFs)
Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices ***I
These raw data are provided by the Open Data Portal of the European Union (data.europa.eu) and are licensed under ODC-BY 1.0.