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MedDRA, the importance of harmonisation

In a world that is more and more globalised, managing international issues was made easier by legal and procedural harmonisation in every...

Orthotics and insoles: Are they medical devices? Do they need CE marking?

Some product groups can put manufacturers in a difficult position, as they are not always able to place their product...

How can I tell a PMC from other products?

In supermarkets’ shelves and other kinds of stores, we can find several products labelled as detergents, disinfectants, or that are attributed with...

The regulatory history of food supplements

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

Medical device regulation: first Eudamed module on line

On 1 December 2020 a further step was taken toward the implementation of the Regulations on medical devices 2017/745 EU and 2017/746...

Startups and food supplements, a growing sector

Ideas need to be developed, and the work market is more and more pushing young graduates as well as people...

Distance sales of medical devices

During the pandemic, which forced shops to be opened with limitations and people to stay at home more than before,...

A cosmetic dossier model? No thanks!

According to the European Regulation, for the marketing of cosmetic products, the relevant responsible person is bound to notify the product...

Food Supplements and Brexit

As of 2021, United Kingdom is no more a Member of the European Union; the Brexit transition period has in fact concluded...

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