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Lingua

Labelling and Readability in the regulated sectors: human medicinal products, biocidal products, medical devices and cosmetics

Human medicinal products The importance of readability in package information leaflets and drugs’ packs is a topic that is becoming...

Cosmetic labelling 2025: 7 rules you need to know to avoid fines

Cosmetic labelling will be the subject of growing controls by competent authorities. The growing attention of the European Union toward...

The Importance of Statistics in Post-Market Surveillance of Medical Devices

Statistics has a central role in the post-market surveillance and in the evaluation of medical device safety. After being placed...

Biocides Things to Know

What Companies should know about PMCs and Biocidal Products

Companies distributing Medical Surgical Aids (Presidi Medico-Chirurgici, PMCs) have been facing for a long time a significant change in regulations:...

Food supplements regulation in Italy.

Food supplements regulation in Italy. A brief guide for 2025

According to the definition of Legislative Decree 169/2004, food supplements are “foodstuffs intended to complete ordinary diet and constituting a concentrated source...

Pharmacovigilance

Pharmacovigilance: MA holder responsibilities beyond authorisation

The responsibilities and obligations of MA holders of human medicines are not limited to the marketing authorisation; on the contrary,...

Data Mining

The use of Data Mining in PMCF data analysis and real-world questionnaires

Data mining is a set of advanced techniques and methods used to analyse huge amounts of data, with the aim...

Legislative Decree 4 September 2024, n. 138

Cybersecurity: the Impact of Legislative Decree4 September 2024 no. 138 on Medical Device Manufacturers

Legislative Decree 4 September 2024, no. 138, adopting Directive (EU) 2022/2555 (NIS 2), introduces important obligations on the subject of...

Step certificazione MDR

MDR Certification Process with a Notified Body (NB)

The certification according to the MDR Regulation (Medical Device Regulation) requires a series of complex phases, that must be followed...