CMC


New MDR and IVDR requirements won


From 25 May 2017, there are some new regulations for Medical Devices and In-Vitro Diagnostic Devices. However, these new regulations won´t be applied to MDR until 26 May 2020 and to IVDR until 26 May 2022. From now to these dates, devices could meet the actual EU medical device directive, or the new regulation, but never use both.

CE certificates issued in this period under the MDD will be valid up to 4 years (MDR) or 2 years (IVDR) from the date of issue.

After the 26 May 2020 (for MDR) and 26 May 2022 (for IVDR) all devices must meet the new regulation.  

New regulations includes:

  • new classification categories of medical devices and in vitro diagnostic devices
  • new classification of unregulated products (products without an intended medical purpose)
  • new regulation for classes of devices that are under a conformity assessment
  • steps that manufacturers must take to meet the MDR/IVDR before placing their device on the market
  • new obligations for different operators in the medical device supply chain (manufacturer, importer, distributor or authorised representative)
  • new post-market surveillance requirements