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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 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...

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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 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...

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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 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...

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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 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...

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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, 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...

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Brexit: United Kingdom vs Europe

Uscire dall'Europa

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...

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New Italian guidelines for food supplements

Nuove linee guida

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...

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Medical Device Software: between old Directive and new regulation

Regolamento software dispositivi medici

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...

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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 for information on the new Regulation (UE) 2017/746, even if it seems too early. Only to some extent, though, as dealing with this issue now, in spite of the time still available, is part of the business logics and vision. Now, as plans must be made in time, and before they shall be mandatorily applied. Now, because strategies must include more options and allow to understand which one is more suitable for one’s own reality. Now, because in an age of quantitative easing, “haste makes waste” is a technical topic as much as a risk management plan. Still, I...

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Technical standards of electromedicals: between old directives and new regulation

Regolamento Elettromedicali

One of the characteristics defining the healthcare medical devices is the high impact of technological factors. Regardless the technological level of a medical device, mechanic, electrical, electronic, information elements as well as others are commonly present. This peculiarity has imposed that the legislator takes into account the prescriptive will to fix minimum safety limits and the need not to bind further the freedom of technical and scientific progress at the base of any practical solution that a medical device represents for a specific problem. Such is the impact of this aspect, that article 5 of Directive 93/42/ECC, i.e. the basis of the current regulation framework, has already included the introduction of harmonized norms by which the manufacturers have the possibility...

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