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In vitro diagnostic medical devices (IVD): from the Directive to the Regulation 2017/746

The transition from the old Directive on in vitro diagnostic medical devices 98/79/EC (IVDD) to the new Regulation 2017/746 (IVDR), which will apply from May 26th 2022, will be more of a landmark than the transition from the Directive on medical devices 93/42/EEC (MDD) to its new Regulation 2017/745 (MDR). Whereas for medical devices, the new MDR represents a systematizing upgrade of many arrangements, positions, procedures and decisions already variously existent in the regulatory landscape (plus new prescriptions that conversely can be also considered as technical extensions rather than new orientations), if not predictable remedies to experiences gained through the years (from scandals to borderline practices), many changes introduced by IVDR with respect to the old IVDD are real novelties...

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Controls on cosmetic sales in Italy

The Italian Ministry of Health has published a communication on their portal, regarding an action by the NAS, the special task force of the Italian ‘Carabinieri’ specialized in the fight against counterfeiting at all levels. Following the controls in shops in several Italian regions, the NAS seized several hundred packs of irregular cosmetic products. The concerned products were of different nature and were recalled as lacking information on their use and any essential information in Italian. Along with the recall of the cosmetic products, the product authorisation holders also received a money fine. Other investigations carried out on the web allowed the NAS to file charges against the holders of a company for the manufacturing and marketing of cosmetics that...

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Regulation on biocides, but there is still a lot to do

Five years elapsed from the date of application of the Biocide regulation, but there is still much to be done both by European authorities and by companies. The review phase of active substances has not concluded yet for the approval of their use in biocide products and many dossiers of products under assessment are still waiting to receive the marketing authorisation. Moreover, in many European countries a transition phase is going on from the local legislation to the European biocide regulation. In particular, in Italy the provisions of the law on Medical Surgical Aids (Presidi Medico Chirurgici - PMC) that applies to some classes of products containing active substance under review are still valid. However, not all the classes of...

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Early problems caused by Regulation 2017/745 on medical devices: MedTech Europe raises the alarm level

The title is not wrong, the new European Regulation on medical devices 2017/745 (MDR) is already causing problems to manufacturers, or better said up to now to manufacturers only, tomorrow who knows, even before coming into application. A first easy question: you are a manufacturer whose medical device CE certificate against the old Directive 93/42/EEC (MDD) has been issued by a Notified Body (NB) designated by United Kingdom, who are you going to apply to for the CE certificate against MDR? Say you choose to change NB, which place do you think you will have, as new customer, in the priority list of your new NB? Say you stay with your British NB, will your current CE certificate be valid...

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No prescription drug advertising, MoH updates

The Italian Ministry of Health has updated its website reporting the appropriate procedures to be followed to apply for the authorisation of advertisements of medicinal products with no need of prescription supplied only by pharmacist (“Senza Obbligo di Prescrizione” - SOP) intended for the public. This is a procedure only recently accepted by the Ministry, that has now become official. The methods for the submission of the authorisation application and the documentation required for the submission essentially correspond to the requirements for the advertising of Over The Counter products (OTCs). However, in compliance with the special type of SOP medicines, there are also specific requirements to be complied with. In particular, each advertising message regarding a SOP product should include...

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Off-label use of medical devices: from the old Directive to the new Regulation

The issue is simple and direct only for the economic operators side (manufacturers, importers, distributors): the lex specialis given by the Directive 93/42/EEC (MDD) and by the new Regulation 2017/745 (MDR) that will apply from May 2020 and will repeal the former, do forbid the off-label use of medical devices.  Art.2 of MDD as well as Art.5(1) of MDR establish that a medical device is placed on the market or put into service, inter alia, if used in accordance with its intended purpose, that equals to no off-label use. An off-label use of a medical device is to all effects a non conform use with respect to the conformity assessment that always precedes the placing on the market of the...

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Agcm fines online sale of not notified food supplements

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...

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Parallel imports of medical devices: changes introduced by the new Regulation 2017/745 (MDR)

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...

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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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