+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz

Lingua

EUROPE: The progressive roll-out of the EU Regulation 2017/746 (IVDR) has been published in the official EU journal

The Regulation (EU) 2022/112 has been published in the official European journal on January 28th, thus formalizing the progressive application...

Registration of MDR compliant medical devices: the Italian MoH database has been updated

The database for medical devices of the Italian Ministry of Health has been object of important updates these days: indeed starting from...

The Key to Success: Creativity and Know-how

Il Sole 24 Ore – November 22, 2021 –Di Renzo Regulatory Affairs, a future-oriented company committed to change With 40 years...

Hazardous ingredients in cosmetic products, updates on regulations

The cosmetic market is under continuous expansion, as the care for one’s appearance remains a constant in the groups of...

Molecular and rapid antigen test kits: the role of in vitro diagnostic medical devices in the pandemic of Covid-19

In vitro diagnostic medical devices play a very important role today in the context of the Covid-19 pandemic, in detail...

Medical devices: MDCG 2021-24 guidance on classification has been published

From the 4th October 2021 on the European Commission website can be found the MDCG 2021-24; the guideline uses the same format...

The European Commission proposes a “progressive roll-out” of the Regulation (EU) 2017/746 (IVDR)

The European Commission has proposed a progressive roll-out of the Regulation (EU) 2017/746 (IVDR) to prevent disruption in the supply of these...

GMP validity extension, Distant Assessment and on site audits: AIFA inspection unit slowly back to normal

Audits at medicines and APIs manufacturing sites are certainly one of the pharmaceutical manufacturing activities that were more affected by...

Monacolins from Fermented Red Rice in Food Products, Updates

Last 5th of October 2021, the European Commission gathered in order to discuss the draft Regulation on the use of monacolins...

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24