Is CE certificate on Medical Devices valid in Switzerland?
Since Switzerland is a Third Country, there is no CE certificate which is valid in Switzerland, that is to say …
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First MDR Certificate for 3DIEMME with the support of Thema
Great satisfaction for the 1st MDR Certificate obtained by 3DIEMME with Thema support With great pride and satisfaction, we communicate …
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What is the “period of grace” and how can I take advantage of it?
The “period of grace” is the time interval, which coincides with the due date, during which a CE certificate issued …
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What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?
The “market surveillance” (performed by the Competent Authority) is the set of activities carried out and the measures taken to …
How can I continue to sell my devices after the full implementation of MDR?
The MDR certificate is a new certification and not an amendment of the Medical Device Directive (MDD) 93/42/EEC. However, pending …
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When will the IVDR 2017/746 enter into force?
The IVDR came into force in May 2017, but there are five years to adjust, until May 26, 2022. During …
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