Category: Blog

The Italian antitrust authority (AGCM) has fined three companies located in Portugal, Slovenia and in the United Kingdom for a total of 400.000 euros by three sentences published last June. The reason behind the sentences is the online sale of food supplements without the relevant notification to the Ministry of Health on websites in Italian. Following a report of the ESSNA (the European body specialised on sport nutrition), the AGCM investigated the sale of food supplements on the web and identified the concerned supplements. These products are sold for muscle building up and improvement of sport performance, for which the AGCM has found that the notification to the Ministry of Health as missing, although mandatory for the sale of food...

Leggi tutto ›

Parallel imports of medical devices is a concept transferred de facto to the medical sector from the pharmaceutical one. The underlying activity is given by the placing on the market of medical devices by a third party different from the legal manufacturer on the Member State territory (importing country) where the legal manufacturer has already placed on the market the medical devices. This is usually possible when the third party purchases the manufacturer devices in another Member State (exporting country), where as well the devices have already been placed on the market by the manufacturer. The concept of parallel imports, when placed in the context of the regulatory framework related to medical devices (old Directive 93/42/EEC or MDD), is not...

Leggi tutto ›

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 up-classified according to the new Regulation 2017/745 (MDR): there is no transitional period established, contrary to what happens for those medical devices that are already today in upper classes and thus come with a CE certificate released by a Notified Body (NB) according to the old DDM. The transitional phase in MDR is addressed in the prescriptions of Art.120. Of the twelve paragraphs comprising it, only paragraph 4 is applicable to class I medical devices. It establishes that a class I medical device according to the current MDD, placed on the market prior to 26 May...

Leggi tutto ›

The Ministry of health has reminded all concerned operators that since 2nd July the notification of the products classified as food for special groups, gluten-free products formulated for people suffering from celiac disease, food added with vitamins and minerals and food supplements shall be done through the electronic system “Alimenti Soggetti a Notifica” (Food subject to notification) only. Through the online portal it will also be possible to submit applications of variation of products already notifies and request Free Sale Certificates In this way, the Ministry of Health intends to make the process more intuitive thanks to automatization of several procedures and allows a better control of the notifications. The process of submission of applications includes the online access through...

Leggi tutto ›

Following some reports, the Ministry of Health has published a memorandum letter to clarify the use of terms and acronyms on food supplement labels. A review has in fact pointed out that forbidden information is reported on the labels of some food supplements, that could cause confusion in the consumers about the appropriate classification of the products. In particular, the acronyms “IBS” (Irritable Bowel System) and “HDL” (Hight Density Lipoprotein), that have a clear medical meaning, have been used, but the competent unit of the Ministry of Health considers them as not appropriate for a food supplement. These acronyms represent in fact a actual indication of the effects of the product and are not supported by suitable claims approved according...

Leggi tutto ›

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 it also takes into account in a more direct and explicit way some types of devices that were previously not fully addressed (software, integrated systems, nanomaterials, etc.) In addition, it was made the choice to modify the conformity assessment procedures on medical devices, both in case a CE certificate by a Notified Body must be obtained and in case no third party evaluation is needed in order to put the device on the market. It is out of scope of the present article to discuss all changes introduced by MDR and differences between...

Leggi tutto ›

The opportunity to focus attention on the topic of the future that awaits medical devices based on substances (for simplicity, SMD), as consequence of the entry into application of the new European Regulation 2017/745 on medical devices (set for May 2020), starts already with Preamble (59), that underlines the lack of sufficient prescriptions in the matter of invasiveness and potential toxicity of SMD in the context of the current regulatory framework (European Directive 93/42/EEC), as well as the lack of classifications that reflect their risk levels. Thus, it was right away imaginable that MDR would have tackled some aspects with more details and it would have provided for an increase of the risk classes related to SMD. Another reason to...

Leggi tutto ›

Everybody knows about the Brexit issue, the exit of the Kingdom of Great Britain and Northern Ireland from the European Union. The Kingdom that is actually an Empire if you consider also the subsidiaries of the Commonwealth and some islands spread into the oceans, with some generous tax system (like Cayman and Bermuda islands). Everybody knows because in the era of the global tribe, the butterfly effect is not any more the typhoon produced in New York due to the a butterfly wings beat in China, but a river of tweets, fake news and instagram photos. It is this very congestion of concepts, meanings, fantasies and realities expressed above in few words that opens up a very simple question: beyond...

Leggi tutto ›

The Ministry of Health has published some updated guidelines on food supplements in its website. In particular, maximum amounts of vitamins and minerals were reviewed along with the list of other substances with nutritional or physiological effect as well as the guideline on probiotics and prebiotics. Changes include the maximum amount accepted for vitamin K, vitamin B6 and selenium, and the inclusion of D-mannose among the substances reported in the list of other admitted ingredients. The updated guideline on probiotics and prebiotics reports the acceptable methods to be used for the identification of the bacterial strain and for the characterisation of yeasts for the identification of both their species and strain. Some components that can be used as prebiotics were...

Leggi tutto ›

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 it) quite marginally. The Directive mentions it seven times: just once to establish that it is to be considered as an active medical device (e.g. as an electro-medical device), and two more times in the definition itself of medical device. Actually, the only explicit provision, representing an Essential Requirement, is given by point 12.1a of Annex I. This subordinates the validation of the software to the state of the art of the reference sector, taking into account the principles of development lifecycle, risk management, validation and verification. All other provisions regard active medical devices and...

Leggi tutto ›