Due to the outbreak of the pandemic of COVID-19, the Medical Devices (MD) manufacturers all along European Union (EU) have had to increase their efforts to supply all the Member States with the vital devices to deal with this crisis. All the healthcare systems are quickly running out of personal protective equipment and ventilators, which is likely to increase both the rate of mortality and the spread of the disease throughout the healthcare professionals.
However, this is not the only matter manufacturers are dealing with, as the Medical Devices Regulation 2017/745 (MDR) will soon fully apply. With all the resources focused on dealing with the pandemic, there is a lot of pressure on the manufacturers and the notified bodies to handle both situations at the same time. That is why the Commission recently announced (25 March 2020) that they are working on a proposal to postpone the application date of the MDR for one year. Their goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.
If you have questions on MDR implementation do not hesitate in contacting us at email@example.com.
Asphalion is here to help you!