Blog

In just over a year, it will be definitively mandatory to affix the UKCA mark on Medical Devices and IVDs to be marketed in the United Kingdom. What to do to ...

2022 is a special year for us at Thema as it is the 15th anniversary of our company. After many years of looking far and wide in the wake of incredible growth, this ...

As is now widely known, as of 26th May 2021, Switzerland became a Third Country for the EU, following Medical Devices Regulatory MDR (EU) 2017/746 full application and in the absence of an ...

It is with great pride and satisfaction that we announce that THEMA is joining to the international Organization RAPS – Regulatory Affairs Professionals Society (www.raps.org). This is further proof of THEMA ...

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 ...