Medical device companies have been scrambling to meet the implementation of the new MDR and IVDR. May 26 has been a major deadline for MDR implementation, and the IVDR goes into effect on May 26, 2022.
MedTech Europe called for the institutions to postpone the implementation of the regulations and resume six months after the coronavirus crisis has passed. Although it remains unclear if and when the outbreak will completely pass, the trade association noted that it could be considered passed when the World Health Organization or another relevant authority declares the pandemic to be over.
“Currently and for the next few months, helping healthcare systems to overcome this outbreak is and will be in everyone’s top priority and focus,” MedTech Europe wrote in a statement. “Manufacturers are striving to keep needed medical technologies available to healthcare systems while managing the effects of the pandemic on their organizations.”
The coming implementation of MDR has already faced a slew of obstacles, with reports in September 2019 suggesting that only about a fourth of medical device companies plan to be fully compliant with the new regulations come May. In November 2019, MedTech Europe accused government authorities of dragging their feet on the process, claiming the industry was held back by the slow implementation of the new framework.