Mar 17, 2022
Europe
The article provides an overview of the new rules for placing surgical masks on the market published by the Italian Ministry of Healthcare. Table of Contents The Italian Ministry of Healthcare announced the new procedure for placing surgical masks on the...
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Jan 19, 2022
Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
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Jan 13, 2022
switzerland
The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
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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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Jul 9, 2019
EU MDR/IVDR
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device regulations, the Spanish regulating authority, the...
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