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 [...]
21 09 2021
21 09 2021
UK: postponed the mandatory UKCA marking. What happens now with Medical Devices and IVDs?
On August 24th ,2021, the UK government decided that mandatory UK Conformity Assessed (UKCA) marking would be delayed to January 1st [...]
21 09 2021
21 09 2021
USA: FDA has increased fees for 2022 fiscal year by 2.5%
The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October 1st [...]
21 09 2021
21 09 2021
BRAZIL: ANVISA, kicks off to UDI system for Medical Devices
At the end of June 2021, the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) presented new details on the next UDI [...]
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 [...]
04 08 2021
04 08 2021
EU: first MDR and IVDR harmonised standards published
In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. Harmonised [...]
04 08 2021
04 08 2021
STANDARD: ISO 20916 regulates clinical performance studies for IVD Devices
The ISO 20916:2019 standard “In vitro diagnostic Medical Devices – Clinical performance studies using specimens from human subjects – Good study [...]
28 07 2021
28 07 2021
MEXICO: amendments to the Medical Devices Regulation from 1 June 2021
Since the 1st of June 2021 amendments to the Health Supplies Regulation (Reglamento de Insumos para la Salud RIS, which also [...]
23 07 2021
23 07 2021
USA: public FDA discussion document to improve cybersecurity in the maintenance of Medical Devices
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has published “Strengthening Cybersecurity Practices Associated [...]
