Eumed^®

Authorized European Representative, EU Representative

Your gateway to the biomedical market in the European Union

Regulatory and clinical consultancy, support services for regulatory compliance, import and registration of biomedical products

In the medical device sector, regulatory compliance is not just an obligation, but a guarantee of quality, safety and success. Eumed® is the trusted partner to deal with every aspect of regulatory cycle and of compliance for medical and diagnostic medical devices, navigating confidently in the complex panorama of European and international regulations.
We accompany economic operators in the biomedical sector – manufacturers, importers, distributors, assemblers – in process management, offering services such as regulatory consultancy, CE marking, quality and technical file management, as well as in the delicate aspect of the import of medical devices also as EU Representative.
We offer the necessary support to correctly interpret the regulations and ensure smooth management and effective processes. With our work, we facilitate the placing on the market and commissioning of medical devices, in vitro diagnostics and biomedical products in perfect compliance with all regulatory requirements.

Our services

From registration of medical devices to import support

EU leader

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EU leader

Per i non-EU manufacturers who wish to market their products in Europe, Eumed® assumes the role of authorized European representative, representing the manufacturer and assisting him in the management of all regulatory obligations and in relations with the competent authorities and notified bodies.

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Extra EU imports

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Extra EU imports

Eumed® offers complete support for regulatory compliance to those who import medical devices, in vitro diagnostics and other biomedical products into the European market. We manage every detail, ensuring rapid and safe access to the market, including customs, insurance and healthcare logistics contractual aspects.

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CE marking of in vitro medical and diagnostic devices

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CE marking of in vitro medical and diagnostic devices

The CE marking it is a basic requirement to place medical and in vitro diagnostic devices on the European market. From the design phase to the management of post-marketing obligations, we offer support to satisfy every regulatory requirement.

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Technical File for medical devices and in vitro diagnostics

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Technical File for medical devices and in vitro diagnostics

It is the documentary evidence that certifies their compliance with community and national standards. Eumed® supports manufacturers in drafting this documentation by also offering its customers FTE, the first and original tool available on the market to organize and manage all the technical documentation relating to biomedical products including operating room systems and kits.

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Registration of medical devices in the national database and in Eudamed

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Registration of medical devices in the national database and in Eudamed

We follow the entire process and all the necessary documentation, to ensure rapid and compliant registration in the Directory of the Ministry of Health in Italy, in the databases of other European states and in the European Eudamed database.

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Classification of in vitro medical and diagnostic devices

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Classification of in vitro medical and diagnostic devices

We offer support for the correct classification of devices in national databases and in Eudamed, according to the CND in Italy, EMDN, MDA, MDT, MDS classifications for the European Union, ensuring that the device is registered and cataloged in a compliant manner.

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Quality Management Systems (QMS)

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Quality Management Systems (QMS)

We offer support in the creation, implementation and optimization of QMS according to international standards such as UNI EN ISO 13485, ISO 9001, MDSAP, ISO 27001 and in accordance with the provisions of the MDR and IVDR Regulations for Quality Assurance.

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Regulation (EU) 2023/988

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Regulation (EU) 2023/988

Eumed offers support to manufacturers in compliance with the obligations set out in Regulation (EU) 2023/988 on General Product Safety, guiding them in the steps necessary to ensure regulatory compliance.

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Assistance to public administration suppliers

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Assistance to public administration suppliers

Eumed® guarantees correct regulatory assistance to public administration suppliers and national and regional service bodies.

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Who is Eumed®

Eumed® S.R.L. it’s a company founded in 2001 by Dr. Riccardo Dainese, sole director, specialized in regulatory consultancy for the medical device sector. CWith the experience acquired in the field of regulatory affairs, he decided to accompany manufacturers in the process aimed at obtaining the CE marking archive also managing all the resulting obligations, including supervision.

Our experience facilitates the understanding and application of complex national and international European regulations also for the public sector. Eumed® It also offers services for the import and compliance of medical devices, management of quality systems and consultancy for participation in public tenders.
The team is made up of specialists with consolidated experience in the regulatory sector. Each member of our team contributes their skills and constant commitment to ensuring tailor-made solutions for each client.