EU/845
WTO/TBT
CE Europäische Union
  • 11 - Medizintechnik
2021-10-28
2021-10-25

In vitro diagnostic medical devices; Medical equipment (ICS 11.040), In vitro diagnostic test systems (ICS 11.100.10)

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (13 page(s), in English)

Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD Regulation) will apply from 26 May 2022. It establishes a new regulatory framework for in vitro diagnostic medical devices including conformity assessment procedures. It was notified to the WTO as notification G/TBT/N/EU/72.

Due to the additional resources required to address the COVID-19 pandemic, it is now clear that national authorities, health institutions, notified bodies and economic operators will not be in a position to ensure the proper implementation and application of the Regulation from the date of application.

With only six notified bodies designated so far, there is a grave shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time. In addition, due to COVID-19 travel restrictions, notified bodies were not able to carry out the required on-site audits at the manufacturers' premises to verify the manufacturing and other relevant processes. This risks significant disruption in the supply of a multitude of in vitro diagnostic medical devices (e.g. HIV tests, pregnancy tests or SARS-CoV-2 tests) on the European Union market.

The draft measure proposes a staggered set of transition periods for devices that are required to undergo conformity assessment procedures involving a notified body. The length of the transition periods depends on the risk class of the devices, with shorter transition periods for higher risk devices and longer periods for lower risk ones. In addition, the notified draft proposes a deferred application of the requirements for 'in-house devices', i.e. those made and used within the same health institution.