Registration in Italy
Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC).
While this Directive is a law to all 27 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.
An example of such local implementation of the Directive is now present in Italy which requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14) only in Italy it is applicable for all classes, not only Class I.
Medical devices introduced to Italian market must obtain the sanitary certificate and be registered.
In order to apply for the Sanitary Certificate for your medical devices, Legal Representative must submit a request for health authorization to import. The documentation accompanying the goods must be attached to the online request – except when the current legislation on the matter provides for the delivery of original documentation.
Furthermore, all non-EU manufacturers of medical devices are required to have an EU legal representative to register their medical device with the Italian database. Non-Italian manufacturers that are based in the EU are also required to complete this registration themselves or appoint a legally-mandated representative to perform a registration for them.
Obelis, as you EU representative will register your devices with the Italian Ministry of Health, on your behalf. The registration can only be done with granted access to the Italian Database, and with the required “smart card” for the actual registration. Your legal representative needs to have access to both.
As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Italian database. Non-Italian (European) manufacturers are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.
This representative will communicate with the Italian Ministry of Health on your behalf. The registration can only be done with granted access to the Italian Database, and with the required “smart card” for the actual registration. Your legal representative needs to have access to both.
Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:
- By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Italy
- If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Italy for a second (third, fourth, etc.) time
- Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.
- For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
- The manufacturer should register their medical devices with the Italian database through his appointed Authorized Representative
Local Legislations like the example of Italy are common in Europe (such as in Portugal) and strengthen the need for a professional European Authorized Representative present at all times.
On 26 May 2021, Medical Device Regulation (EU) 2017/745 will repeal Medical Device Directive 93/42/EEC. Until EUDAMED database allowing registration at EU level is functional, current- Directive registration process will continue. Nevertheless, Member States might continue requesting a separate registration to their national database.
If you are directly importing cosmetics product to Italian ports be aware that your Legal Representative must submit a request for health authorization to import called Nulla Osta Sanitario (NOS), also known as the Sanitary Certificate. The procedure consist of an online request on the Electronical Italian Ministry of Health database, and includes several data like information on Manufacturers, Importers, Goods, documents and the provision of TAX.
Food supplements may be subject to the requirements of the national registration as a pre-market authorization. For more information, contact us today!
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