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Custom-made devices and Regulation 2017/745

Article 1, section 2 of the Medical Device Directive 93/42/EEC defines as “custom-made device” any device specifically made in accordance with...

Cosmetic products advertising: harmonised rules in the EU

Cosmetic products are regulated at European level by a regulation that is applicable directly to all Member States. Even if...

Advertising of medicinal products to health professionals means more protection for patients

“Advertising of medicinal products” means any action informing, searching for customers or any exhortation, intending to promote the prescription, supply, sale...

Medical devices made of substances and Regulation EU 2017/745

The date of application of Regulation EU 2017/745 as amended was officially postponed of one year (May 2021), also postponing the abrogation...

How to obtain the CE marking for personal protection equipment (PPE)

PPE is a class of products with essential relevance in the management of the COVID-19 emergency: this includes filtering masks and...

Incidents, safety corrective actions and safety warnings: the vigilance system of medical devices.

The main scope of the vigilance system is to increase the safety profile of medical devices (MDs) and to improve the users’...

DPI, telematic transmission activated for validation waivers

As of 13 May, a new method of telematic transmission is active on the website of the National Institute for...

Drug traceability, all subjects involved

Drug traceability is a relevant but delicate aspect of pharmaceutical management. It allows the univocal identification of each single pack of...

Indication of the origin of a primary ingredient of a food

The Commission implementing regulation (EU) 2018/775, laying down rules indicating the country of origin or place of provenance of the primary ingredient of...

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