Do you want to import a medical device from a non-EU country?

What responsibility do I have as an importer? 

What documentation should I request from the manufacturer? 

Can I trust this non-European manufacturer? 

Can Eumed act as an agent?

...


We can give you clear and effective answers.

Contact us


Eumed is a company prepared to manage the regulatory, administrative, technical and legal issues related to the marketing, commissioning and management of the supervision of biomedical products and services (including outsourcing), also as an Authorized European Representative (authorized representative in the European Union pursuant to Directives 93/42, 2007/47/EC, MDR 2017/745). 

Eumed follows all the activities of registration and listing of medical devices with a view to their distribution in Italy and in the European Union, the presence of qualified personnel in dealing with issues relating to labelling, instructions for use, management of non-conformities, complaints and accidents is a further and qualifying added value for the customer, preventing potential risks in this regard and avoiding burdens arising from the timing and costs of the staff of the customer involved in reporting, treatment and resolution of these issues. The collaboration with an important law firm specialized in administrative and civil law allows us to offer qualified legal advice in private and public contracts, including the management of trademarks and patents.  

Eumed offers its clients a complete service, aimed at companies that manage transactions with non-EU countries, for the import of medical devices, medical and surgical devices, drugs and biomedical products in the European Union.  

Eumed's expertise also allows less structured companies to take advantage of all the opportunities offered by producers in areas of strong growth or already well established (USA, Canada, countries in the B.R.I.C. area, China and the Far East) for:  

  • support for the management of relations with suppliers and the drafting of contracts;
  • management of import procedures and transport organisation;
  • insurance coverage;
  • compliance with regulatory and regulatory requirements;
  • documentary and inspection checks on compliance with European regulations;
  • vigilance.

Eumed's competence as Authorised European Representative and Authorised Representative in the European Union has the primary objective of relieving the distribution company of the responsibilities that European legislation places on the person who places products from third countries on the Community market. 

This creates a precise point of reference that, in the event of litigation or serious problems such as accidents or recalls from the market, can manage with high professionalism the relationships between authorities, manufacturers, retailers and end users of products, without any involvement of distributors. Our partners and customers can benefit from our expertise and all the complex specialist services (administrative, legal, regulatory, logistical, commercial) concerning the marketing of their products in the European Union and in Italy, to be able to proceed to a safe commissioning of the same in the national and EU, in full awareness of their responsibilities and maintaining the autonomy of management of their business. 


Elements of the service 

First of all, we can clearly separate the responsibility of the importer from that of the distributor. The regulatory framework on product liability, in fact, identifies the importer within the Union as the ultimate party responsible in the event of damage to third parties (art. 3, 113 and 115 of Legislative Decree no. 206/2005 "the Consumer Code"), in addition to the provisions of civil, administrative and criminal national rules and Directives 93/42/EEC and 2007/47/EC, pending the further specific rules that will be imposed by the new European Regulation on medical devices which is expected to be approved by the end of 2016. 

Secondly, importation may involve high financial exposure in connection to risks, especially those related to the conditions of return imposed by suppliers. The separation of responsibilities, also in this case, serves to prevent the current distribution company in the event of problems with the import procedures.  

Eumed is indifferent to the choice of suppliers and products, which remains the sole responsibility of the customer. The fist step of the negotiations is therefore made by providing Eumed with the indications of the suppliers, products and elements of the supply for which an agreement in principle has been reached, it being understood that the conduct of commercial negotiations falls within the scope of Eumed's activity. 

The stipulation of purchase contracts with suppliers identified by the client is an activity that can be delegated to Eumed, which may request, if necessary, the assistance of a manager of the client during the phase of commercial negotiation. Other elements already agreed upon, but not essential (for example, guarantees, commercial support, methods of placing orders), represent the minimum level of contractual conditions that Eumed is delegated to deal with, considering that in any case it will be entitled to obtain better conditions than those officially proposed to the client. Return conditions, transport contracts, insurance, terms and conditions of payment are aspects that can be negotiated with the assistance of Eumed. 

The contracts, before they are signed, will be subject to approval by the client and will remain at his complete disposal. Any changes to the contract must be agreed between the client and Eumed, which will formalise them to the supplier.