WHO IS THE CH REP?
Following the failure to achieve an institutional agreement between Switzerland and the European Union, Switzerland made the CH REP nominee [...]
18 10 2021
18 10 2021
08 10 2021
08 10 2021
Which acronyms and terms must a Quality&Regulatory professional know?
In the field of medical and in vitro diagnostic devices, being familiar with acronyms and most used definitions regarding Regulatory Activities [...]
07 09 2021
07 09 2021
IVD: the MDCG publishes the IVDR Implementation and Preparation Plan (EU) 2017/746
In June 2021 the Medical Device Coordination Group (MDCG) published on the website of the European Commission the IVDR Preparation and [...]
08 06 2021
08 06 2021
European Authorised Representative, Swiss Authorised Representative and UKRP: roles and responsibilities
The regulatory regimes of the Old Continent are undergoing great change: the scenario is fairly heterogeneous and far from a standardization [...]
31 05 2021
31 05 2021
MDR: Switzerland becomes a Third Country in the Medical Device Sector
UPDATE 31/05/2021 Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the [...]
18 05 2021
18 05 2021
Adverse Events: what should MD and IVD Manufacturers do according to FDA?
In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR), the Food and Drug Administration (FDA) requires [...]
01 02 2021
01 02 2021
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 that [...]
19 01 2021
19 01 2021
Impending deadlines: what do you need right now?
Discover Thema services to reach your objectives in time! Impending deadlines: what do you need right now? The regulation of Medical [...]
02 12 2020
02 12 2020
May 26, 2021 MDR: time to act now!
Short time to May 26, 2021 which is the date of full implementation of the Medical Devices Regulation MDR (EU) 2017/745. [...]
08 09 2020
08 09 2020
In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746: main changes
The Regulation on In Vitro Diagnostic Medical Devices IVDR (EU) 2017/746, published on May 5, 2017 and entered into force on [...]
