Switzerland medical services are your representative from medical appliances in Europe. Use us as your representative in the EU. Safe way to the European market! SIX

Switzerland medical services are your representative from
Medical equipment
in Europe.

Use us as your representative in the EU. Safe way to the European market!

Six necessary steps

Path to your CE marking

Determine applicable directives

Determine applicable requirements

Product Compliance Evaluation

Drawing up all technical documentation

Creating a CE certificate, enhancing manufacturers in the Swiss Medical Services Branch

CE sign

In particular, due to current changes in circulation and verification of the CE sign, products from non-European countries are checked by supervisory authorities, as well as checking all the requirements related to it. If the manufacturer cannot provide evidence of this, it risks to get significant penalties and loss of the commodity type.

In principle, these problems can be solved only with an authorized representative of the EU, which exercises this activity for the manufacturer in Europe, i.e., on the one hand, it confirms the quality of products by checking the standard in a qualified and accredited test institute, on the other hand, It provides all the requirements of MPG.

Manufacturers who will not be able to prove that they are represented in the EU, it will be much more difficult to access the market.

What we suggest you!

Exit to the market of non-European manufacturers is a complex and long process. In order to register its products in European health systems, medical equipment manufacturers should be familiar with the requirements of registration systems operating in specific countries.

REGISTRATION

Registration of the non-European manufacturer in the competent authorities.

Eudamed

Registration in the European Eudamed database, if possible (2022)

Compliance procedure

Registration of a medical device / implementation of the compliance procedure, if necessary, also in collaboration with the relevant Test Institute (TÜV AUSTRIA).

DATA

Storage and provision of technical documentation for medical equipment to the competent authorities in all EU countries and (if necessary) to the notified authority.

Key person

Contact person of all competent EU bodies. Sending relevant information issued by the competent authorities

Consideration of the case

Coordination in the event of incidents between interested persons, competent authorities, a notified body and manufacturer.
Processing of incidents and organization and monitoring of reviews.

These tasks require deep knowledge of European legislation on medical equipment, the ability to conduct medical and technical assessments and maintain links with the competent authorities throughout the EU.

Swiss Medical has the necessary experience in the medical equipment market and cooperates in the European market exclusively with certified specialists. This is the only way to guarantee the high requirements of EU directives and EU regulations to the so-called placement of medical products on the market.

EU representation costs

SWISS Medical Services is a reliable and competent representative of medical products.

Annual main costs of ensuring the work of the representative office, the security officer and the medical consultant:

Once € 12.000, –
Plus annual revenue
(by agreement)

Conducting a compliance procedure, if necessary, also in collaboration with a notified authority:

In terms of cost with a separate invoice

Coordination in the event of incidents between interested persons, competent authorities, a notified authority and manufacturer:

In terms of cost with a separate invoice

Please feel free to contact us if you have additional questions.

The first placement of the EU representative office in the medical product market!

Non-European manufacturers of medical equipment have the opportunity to work on the non-European market only if they completely delegate these duties to the EU representative.

In accordance with § 5 mpg, the manufacturer or its authorized representative is responsible for the first placement of medical equipment in the European market. If medical equipment is not imported into the European economic zone for responsibility of the authorized representative, the importer is responsible for this. However, only very few dealers are ready to take over this responsibility along with all the consequences provided for by the law on liability (see Casus Wintersun).

Immediately after the conclusion of the relevant Agreement between the Swiss Medical Service and the non-European manufacturer, the EU representative proceeds to work and assigns the responsible for safety according to § 30 mpg, which is registered in the competent authority. This person should be able to provide evidence of the necessary qualifications (usually these are relevant research, for example, in the field of medicine or engineering). It must control the risks associated with medical devices, and take appropriate measures. He must also fulfill obligations to notify.

In addition, in accordance with § 31 mpg, a medical consultant is appointed. This person is responsible for providing information on products to medical professionals and instructs them by proper handling of medical products.