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Citing Coronavirus Pandemic, MedTech Europe Seeks Delay in New European IVD Regulations

NEW YORK – MedTech Europe on Monday called for a halt on the implementation of new regulations for the in vitro diagnostic and medical device industries in light of the coronavirus pandemic.

In a statement, the trade association said that during the current crisis, the medical technology industry's ability to meet the deadlines for the new medical device regulation (MDR) and in vitro diagnostics regulation (IVDR) will be severely strained as it attempts to bring technologies to healthcare systems. As a result, MedTech Europe is calling for a six-month postponement in the implementation of the regulations.

The MDR is scheduled to take effect this May, when device makers would need to have their equipment in line with the new requirements. For test makers, the IVDR deadline is May 2022.

They would change the regulatory landscape in Europe by putting in place more stringent requirements for diagnostic tests and a wide range of medical equipment before they could be marketed to the public.

The implementation process has been a bumpy one, and many firms, particularly smaller shops, had already voiced concerns about their ability to meet the new deadlines. For example, the shortage of so-called notified bodies, which certify that tests and devices meet the new requirements, has been an ongoing issue. 

MedTech Europe said that during the current pandemic, the medical technology industry is "working relentlessly" to provide medical equipment to patients, healthcare workers, and hospitals, an effort that will be the top priority for the next few months. In asking for a delay in implementation of the MDR and IVDR, the trade organization, which represents diagnostics, medical devices, and digital health firms, suggested implementation to start, for example, six months after the World Health Organization or a similar "relevant authority" declares the pandemic over.