EU Regulatory Roundup, April 2020: MDR Delayed As EU Manages COVID-19 Crisis
COVID-19 is now entirely dominating the world of medtech. It has forced the commission to delay the MDR. While the sector tries to grapple with the impact, it is also having to adjust to a healthcare market that is driven by coronavirus demands.
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Non-CE-marked products on the EU market, virtual notified body audits, free standards and the Commission bid to pause the MDR. March has seen unprecedented developments as COVID-19 has railroaded through the sector decimating regulatory rules and plans.
Those marketing products covered under the EU’s MDR and IVD Regulations have plenty of reading this month to help them prepare. More details have also emerged about the UK’s regulatory future.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?