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UDI tracking of medical devices and in vitro diagnostics: new rules in January 2024

On 8 January and 15 January 2024 the obligations on the traceability of some types of in vitro diagnostics and...

Are you really ready for the Regulation?

With the increasing requirements to obtain the MDR conformity, much more than for the MDD as well as the reduction...

Il tempo per gli MDR

Timetable for the compliance with the MDR/IVDR and Notified Bodies: where we stand

In July 2023 the European Commission has published the first results of the survey carried out by Gesundheit Österreich GmbH...

Importare parallelamente

Here what should be done by company wishing to import drugs from parallel markets

Parallel market (importation) is founded on the principle of free movement of goods inside the inner (European) market. In the...

Do you want to market your medical devices in the united kingdom?

    Following Brexit, the United Kingdom has started to introduce new rules for the marketing of medical devices (MDs)...

Cannabidiolo ad uso orale

CBD preparations for oral use derived from cannabis extracts in the narcotic tables, the Ministry Decree and the Regional Administrative Court suspension

The decree of the Ministry of Health of 7 August 2023 “Revocation of decree 28 October 2020 of «Suspension of...

dispositivi medici su misura

New registration procedure for manufacturers of custom-made medical devices

A “custom-made device” means any device specifically made in accordance with a written prescription (…) which gives specific design characteristics,...

Digitalizzazione farmaci

EU RA procedures go digital: the new application form format (eAF) and the new product data format (PMS) – update July 2023

The European Medicine Agency (EMA) is working on the digitalisation of regulatory processes for medicines with the aim of facilitating...

Use of forbidden claims on food supplements

The use of food supplements in Italy is increasingly widespread, but at the same time the presence on the market...