- 13 April 2022
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 ...
- 13 April 2022
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 ...
- 10 March 2022
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 ...
- 15 February 2022
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 ...
- 8 October 2021
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 ...
- 8 October 2021
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 ...
- 7 September 2021
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 ...
- 8 June 2021
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, ...
- 31 May 2021
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 ...
- 18 May 2021
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 ...