Feb 3, 2020
Europe
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, published guidance aimed to assist medical device manufacturers facing notified body withdrawals. According to the guidance, if a notified body...
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Jan 10, 2020
EU MDR/IVDR
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal Status The new framework introduced by these...
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Nov 27, 2019
Europe
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued a final version of the assessment form intended to be used by designated authorities to select a notified body. Notified Bodies and Conformity Assessment Bodies The MDCG, an...
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Sep 19, 2019
EU MDR/IVDR
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to provide assistance to regulating authorities and...
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Aug 23, 2019
EU MDR/IVDR
All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses. CE Certificate Renewal Requirements According to the...
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