MedDRA, the importance of harmonisation

Traduzione Meddra

In a world that is more and more globalised, managing international issues was made easier by legal and procedural harmonisation in every field. Tools such technical harmonisation and mutual recognition agreements were actually very important to streamline and speed up the approval of medicines, manufacturing processes, reference standards. At global level, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) represents a precious tool: in fact, the ICH gathers the regulatory authorities and pharmaceutical industries of several countries and organisations to discuss and harmonise technical and scientific aspects regarding human medicines, generating harmonised guidelines to be used as a reference point in all adhering countries. Established by the European Commission, the US FDA and the...

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

Marchio CE solette ortopediche

Some product groups can put manufacturers in a difficult position, as they are not always able to place their product in the appropriate legal context. Possible errors of evaluation can also occur for categories such as orthotics and insoles that, as a start, can be considered as simple clothing accessories. However, it should be specified that in many cases insoles and orthotics are to be placed in the category of medical devices. According to the legislation currently in force, i.e. Directive 93/42/EEC as adopted by the single EU Member States, these are products intended to be used with a medical purpose. Consequently, if orthotics and insoles claim either any improvement for the health of the user or that they prevent...

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How can I tell a PMC from other products?

Riconoscere disinfettanti

In supermarkets’ shelves and other kinds of stores, we can find several products labelled as detergents, disinfectants, or that are attributed with similar properties. However, it is not often easy for consumers to make a conscious choice, as some indications look alike, even if the products present different characteristics. It is therefore essential to be familiar, even generally, with the regulations, and be aware of what we are looking for. If we need a disinfecting product (for hard surfaces such as floors, tables, etc.; or for our hands) then we should find, stated in its label, that the product is registered as PMC (Presidio Medico Chirurgico, medical surgical aid). There is no dedicated symbol identifying PMCs. Companies often include a...

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The regulatory history of food supplements

Normativa degli integratori

According to the definition of Legislative Decree 169/2004, food supplements are “foodstuffs intended to complete ordinary diet and constituting a concentrated source of nutrients, such as minerals and vitamins, or other substances with a nutritional or physiological effect including, but not limited to, amino acids, essential fatty acids, fibre and herbal extracts, with either one or more ingredients in their composition, in pre-dosed forms”. The European Food Safety Agency (EFSA) stresses that food supplements can contain “a wide range of nutrients and other ingredients”, including vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts. In the European Union, food supplements fall into the wider category of foods, and therefore they follow all European regulations on...

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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 EU (MDR and IVDR). It is the entering into function of the first module of Eudamed, the single European database introduced by the Regulations, that follows Eudamed2, a much less extended database existing under the current directive, with access reserved for Member States competent authorities. Eudamed can be accessed directly from the European Commission website; in fact, it was designed to be an interconnected and multifunctional database, made of a web page that can be consulted by the public as well as of the following 6 modules: Actors registration UDI/Devices registration Notified Bodies and Certificates Clinical Investigations and...

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Startups and food supplements, a growing sector

Startup integratori alimentari

Ideas need to be developed, and the work market is more and more pushing young graduates as well as people with good ideas to step up their game and launch a startup. In the last few years, startups in the field of food supplements have been markedly growing. To create a company operating in the field of food supplements, however, legal requirements should be complied with, and specific registrations should be performed. For many “new entrepreneurs” the first issue is to collect the funds required to launch their idea. Actually, the first step to take should be to trust regulatory professionals that can suggest solutions to avoid any surprise on a project that could turn into a disaster at the...

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Distance sales of medical devices

Vendita a distanza

During the pandemic, which forced shops to be opened with limitations and people to stay at home more than before, a real boom in online sales has been observed. Distance sales involve medical devices, which can be purchased both by means of platforms including products of several commodities sectors and by directly contacting manufacturers and distributors through their websites, if any. Since the beginning of the pandemic the availability in the e-commerce of specific medical devices, such as surgical masks or pulse oximeters, substantially increased due to the importance of these medical devices in fighting the disease. However, online sales do not always meet all the requirements according to the legislation specific to the MDs. The Directive 93/42/EEC does not...

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A cosmetic dossier model? No thanks!

Esempio di PIF Cosmetici

According to the European Regulation, for the marketing of cosmetic products, the relevant responsible person is bound to notify the product into an online portal and prepare a dossier (PIF - Product Information File). What is the PIF of a cosmetic product? It is a dossier needed to demonstrate the safety and efficacy of the cosmetic product through data, calculations, references and studies. The Regulation provides indications on what should be reported in the PIF. Some European guidelines are also available and can be useful to assess the characteristics of the product. However, there is no standard form to be filled in for the drafting of each product. Indications and guidance on the PIF preparation can also be found in...

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Food Supplements and Brexit

Integratori alimentari Bexit

As of 2021, United Kingdom is no more a Member of the European Union; the Brexit transition period has in fact concluded on 31 December 2020. The consequences on norms and regulatory affairs are many, and affect all sectors. For food supplements and food subject to notification, the Italian Ministry of Health will not accept any notification by Food Business Operators (FBOs) legally located in the UK, as this is now a third country outside EU. In general, in order to market food supplements on the Italian territory, it is required that FBOs perform the relevant notification in the online portal of the Italian Ministry of Health enclosing the label of the product. After a positive evaluation by the authority,...

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The false myths of Regulatory Intelligence

Regulatory Intelligence

Regulatory Intelligence: the world of regulatory affairs has been talking of nothing else. And if, on one hand, this is certainly a key tool available to the professionals of this sector, on the other hand there is much misinformation on this regard. Regulatory Intelligence is none other than a set of information, especially of regulatory nature, that can support the development of drugs, but also of guidelines or health policies, and whose knowledge allows companies to shape their strategies, avoiding any waste of time and resources, thus aiming at the goal directly. An example of the application of the Regulatory Intelligence is collecting information on local regulations for marketing authorisation procedures of medicines and other products, whose critical examination allows...

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