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Presidio medico chirurgici

From PMCs to Biocides – An Ariadne’s thread to navigate the labyrinth of Italian and European legislation

Let’s face it, the introduction of a European directive on biocides has greatly confused and frightened the many interesting industries...

Disinfettanti

Safety and efficacy of everyday products

How can we be sure that a common disinfectant is really effective against bacteria and harmful organisms? And the doubt...

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...