Feb 4, 2020

The European Commission issued a  “Call for Applications” to industry organizations, urging them to select observers to sit on the sub-group of the Medical Devices Coordination Group (MDCG) devoted to MDR Annex XVI devices. This annex designates “products without an intended medical purpose,” such as contact lenses, liposuction equipment, and electrical equipment used for brain stimulation.

Topics and application deadline

The announcement specifies that the working group will focus on implementing safety and performance requirements specified in MDR Annex I; defining the obligations of economic operators; and producing guidance documents addressing qualification and technical aspects of products, all in reference to Annex XVI devices. The deadline for submitting applications for observer selection is February 28, 2020.

Learn more about European MDR and IVDR compliance at Emergo by UL:

  • European MDR compliance preparation and resource center
  • On-site EU MDR training for medical device manufacturers
  • European Authorized Representative in-country representation
  • EU MDR gap assessment and transition strategy for medical device companies
  • Whitepaper: Understanding Europe’s Medical Devices Regulation