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The new EU Medical Device Regulations has taken effect as of May 26th. While the MDR was announced in 2017, and given a 5 year transition period to avoid disruptions to the market, there are still those that worry there may be disruption to product supply.
Some worry that there is limited capacity among the notified bodies and also non-harmonized interpretation of the rules through the EU.
An unforeseen, but obvious challenge has been the ongoing Coronavirus Pandemic, making manufacturers unable to complete certain MDR projects because the cannot complete on-site audits.
The Eruopean Commissioner for Health and Food Safety stated in a Press Release that, “The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges.”
