EU Authorized Representation at its best

Need assistance complying with US FDA, European or other global medical device regulations? mdi Europa is your single source for helping you access the largest and fastest growing medical device markets worldwide.

mdi Europa was created in 2000 to provide high quality regulatory affairs services. Our customers are manufacturers, importers, exporters and distributors of medical devices and in vitro diagnostics world-wide. Our high quality compliance solutions, as confirmed by our ISO 9001:2015 certification, include classification, identification of EU standards, technical documentation compilation and review, product registration to national EU Authorities, Labeling Compliance, Free Sales Certificates, market research, translation services, and more – all of these are provided either by our own team or via our extensive network of experts.

Our most important focus in this environment, however, is to provide first class EU Authorized Representation Services as defined by the applicable EU Directives and Regulations, such as

MDR – Medical Devices Regulation 2017/745
IVDR – In Vitro Diagnostic Medical Devices Regulation 2017/746

Choosing the perfect EU Authorized Representative for your specific needs will have a vast impact on a smooth and reliable regulatory status of your products. Ask our team what we can do for you do reduce your time to CE-mark in the best possible way.

The registration of  medical devices confronts the manufacturers with significant challenges. National and international regulatory requirements are continually developed and specified. Alongside the well-known registration and certification procedures in the United States (FDA) and Europe (CE), every month new regulations for many other countries appear. The perfect way to the market is not always easy to define and requires a wide range of experience. mdi Europa offers high quality consultancy service to guide your way to the target market for your company and the products you manufacture.

The CE mark enables free movement of goods within the European Union. However, the national implementations of the regulations for medical devices and in vitro diagnostics partially require a country-specific registration. While the CE mark enables the penetration of the European market, non-EU countries which did not sign the Hague Convention require a so-called Free Sales Certificate (Certificate of Marketability). mdi Europa takes care of the application for a Free Sales Certificate on your behalf and organizes legalization and apostille as and when necessary.

We kindly invite you to visit all areas of the mdi Europa website to find out how mdi Europa can assist your company.

European Authorized Representative

If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint an European Authorized Representative located in Europe to act as your liaison with the national Competent Authorities. mdi Europa acts as independent EU Authorized Representative for hundreds of medical device manufacturers worldwide. Learn more…

CE Consulting Medical Devices

We specialize on regulations for medical devices and in vitro diagnostic medical devices. Find more information on our customized service solutions here. Learn more…

MDR – Medical Devices Regulation 2017/745

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Learn more…

IVDR – In Vitro Diagnostic Medical Devices Regulation 2017/746

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Learn more…

CE Consulting Electrical Equipment

Whilst being focused on regulations for medical devices, we also offer services for overlapping regulations. If you intend to market electrical or electronic devices, please visit this subpage for more information. Learn more…

CE Consulting Environmental Requirements

Simply complying with the medical devices Directives is not sufficient anymore. Environmental aspects become more and more important in the EU. Find more information on environmental requirements applicable to your devices here. Learn more…

Library

Being up to date with regulatory updates is vital to guarantee compliance at all times. mdi Europa provides a vast variety of downloads and links to support you in this matter. Learn more…

Partners & Associates

Offering our clients a world-wide one stop solution is our goal. We have thus identified coorporation partners specialized on specific services. Visit this page to learn more about additional services in the EU, the US, Latin America, China and the Middle East. Learn more…

References

See what our clients have to say about our team and our services. Learn more…

Team mdi Europa

Learn more about our team and identify the right contact person for your query. Learn more…

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