On August 24th ,2021, the UK government decided that mandatory UK Conformity Assessed (UKCA) marking would be delayed to January 1st [...]
The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October 1st [...]
At the end of June 2021, the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) presented new details on the next UDI [...]
In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. Harmonised [...]
The ISO 20916:2019 standard “In vitro diagnostic Medical Devices – Clinical performance studies using specimens from human subjects – Good study [...]
Since the 1st of June 2021 amendments to the Health Supplies Regulation (Reglamento de Insumos para la Salud RIS, which also [...]
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has published “Strengthening Cybersecurity Practices Associated [...]
In June 2021, the Medical Device Coordination Group (MDCG) published the Q&A Guide to answer some of the most significant questions [...]
On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal [...]
One month has passed since the date of full application of the MDR Regulation (EU) 2017/745 for Medical Devices and there [...]
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