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Regulation on medical devices 2017/745 (MDR): focus on class I medical devices affected by up-classification

There is a predictably puzzling issue related to class I medical devices according to the present and old Directive 93/42/EEC (MDD) that will be...

Online notification for special food and food supplements

The Ministry of health has reminded all concerned operators that since 2nd July the notification of the products classified as food...

Ministry memorandum letter on improper use of terms and acronyms on food supplement labels

Following some reports, the Ministry of Health has published a memorandum letter to clarify the use of terms and acronyms on...

Regulation on Medical Devices 2017/745 (MDR): conformity assessment procedures

The new Regulation on medical devices 2017/745 (MDR), that will apply from May 2020, introduces a revision of risk classes to be attributed to medical devices and...

Regulation on medical devices 2017/745 (MDR): focus on substance based medical devices

The opportunity to focus attention on the topic of the future that awaits medical devices based on substances (for simplicity,...

Brexit: United Kingdom vs Europe

Everybody knows about the Brexit issue, the exit of the Kingdom of Great Britain and Northern Ireland from the European Union. The...

New Italian guidelines for food supplements

The Ministry of Health has published some updated guidelines on food supplements in its website. In particular, maximum amounts of vitamins...

Medical Device Software: between old Directive and new regulation

The current regulating framework, based on Directive 93/42/EEC, regulated the software intended by the manufacturer to be a medical device (or to be part of...

In Vitro Diagnostics (IVD): an update in view of Regulation 2017/746

At least until May 2022 we will remain in the era of Directive 98/79/EC, started 20 years ago. Many clients ask...

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