Trade association MedTech Europe has called for a pause on the implementation of new EU MDR and IVDR regulations following the outbreak of COVID-19.
MDR is due to come into force on 26 May this year, with IVDR scheduled to be implemented two years later. It is calling on European institutions to postpone implementation and resume the process six months after the crisis has passed – saying it could be considered passed when “the World Health Organization or other relevant authority (where critical preparedness activities are ongoing) declares the pandemic to be over.”
MedTech Europe has said that a postponement could help safeguard healthcare systems as they work to tackle the pandemic.
A statement from the organisation, said: “The industry is working relentlessly to provide personal protective equipment (PPEs), diagnostics, respiratory devices and other critical medical equipment to patients, healthcare workers, and hospitals on the COVID-19 frontline.
“At the same time as fighting COVID-19, it is critical to maintain the seamless availability of all other medical technologies needed daily to diagnose, treat and monitor patients suffering from other critical or chronic health conditions.
“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. Manufacturers are striving to keep needed medical technologies available to healthcare systems while managing the effects of the pandemic on their organisations.
“This severely disrupts healthcare stakeholders’ efforts to implement the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) within the fixed transition timelines, which expire on 26 May 2020 and 26 May 2022 respectively.”
You can read MedTech Europe's statement in full, here.
