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Following the failure to achieve an institutional agreement between Switzerland and the European Union, Switzerland made the CH REP nominee compulsory. CH REP is a physical or legal person with ...

In the field of medical and in vitro diagnostic devices, being familiar with acronyms and most used definitions regarding Regulatory Activities and Quality is very important, if not vital, in ...

In June 2021 the Medical Device Coordination Group (MDCG) published on the website of the European Commission the IVDR Preparation and Implementation Plan (EU) 2017/746 for in vitro Diagnostic-Medical Devices ...

The regulatory regimes of the Old Continent are undergoing great change: the scenario is fairly heterogeneous and far from a standardization process. In particular with regard to the European Union, ...

UPDATE 31/05/2021 Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered ...

In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR), the Food and Drug Administration (FDA) requires Manufacturers of Medical Devices (MD) and In Vitro Diagnostic ...

Great satisfaction for the 1st MDR Certificate obtained by 3DIEMME with Thema support With great pride and satisfaction, we communicate that our Customer 3DIEMME srl has obtained its first MDR (EU) ...

Discover Thema services to reach your objectives in time! Impending deadlines: what do you need right now? The regulation of Medical Devices has changed for a long time but the date of ...

Short time to May 26, 2021 which is the date of full implementation of the Medical Devices Regulation MDR (EU) 2017/745. If you are a Manufacturer, an Economic Operator or ...

The Regulation on In Vitro Diagnostic Medical Devices IVDR (EU) 2017/746, published on May 5, 2017 and entered into force on May 26, 2017, provides rules and requirements for placing ...