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Market Entry In Europe

The European Union – now counting 27 member states – constitutes one of the largest common markets in the world with a population of about 500 million.

With roughly a 20% share of the world's imports and exports of goods and services, the European Union is one of the key players in international trade. European trade policy is implemented as a result of joint decisions by the European Commission. That means that decisions can only be made at Community level and not by individual EU member states.

Europe is the second largest Medical device market, second only to the US and before countries like Japan, and Australia. This poses attractive opportunities for international companies trying to enter the European market. However, to be successful, it is essential that companies comply with and are able to meet local requirements and regulations.

Free movement of goods and capital is a benefit for all EU member states and all trade partners. Since EU law is fully in force in all member states, conditions are in place to protect investment, intellectual property and employees, and ensure high safety, production and environmental standards.

Enter the European markets or expand your European market share now. You can count on the Admirus expertise for trade and commerce with the European markets. Your market experts for Europe!


    Admirus's industry-savvy consulting services will help guide you to the whether, how and where to start business and the know-how to expand your market share in Europe. We along with our partners in Europe develop smart expansion strategies and go-to-market strategies based on a broad international industrial and management experience. Whether you want to export your products, build up an overseas branch or look for a distributor, you can count on a reliable partner like Us. Admirus

    We can assist you with

    • Export of existing products
    • Partnering with distributors
    • Licensing
    • Franchising
    • Joint venture
    • Overseas branch
    • Subsidiary

    Moreover we combines all aspects of business development, markets, industries, legal, tax, administration, Business Process Outsourcing, human resources, and business location.

    Your profits depend on which business partners you choose to work with. Whether you are just looking for a business partner who would be exactly what you need, or need assistance to get in touch with potential partner, or want to expand your business and need cooperation - we are ready to be there for you. We offer you best services to find your ideal partner. Business buyers, business sellers, business investors, business opportunities - for reasonable prices and on better terms than anywhere else. Full attention to all your requirements concerning goals, objectives, pricing parameters, terms, conditions, timing and confidentiality.

    Focus on European Markets

    The markets are the starting and ending point of all business. Admirus offers broad-based, in-depth expertise and an understanding of all key industries. We can provide you with the kind of high-quality, transparent market feedback you need. Our team is well-versed in the full spectrum of online and offline marketing campaigns - from strategy development to project management, execution and project controlling. There is a power to strategic market design built upon consistent market focus and expertise - power for business success. Admirus, with its broad industrial and management experience, can also help your business harness this power through carefully honed strategies, processes and actions.

    Events and Trade Shows
    • Development and management of booths at national and international trade shows
    • Development, implementation and project management of online events
    • Development, implementation and project management of conferences and events for executives and decision-makers
    • Adaptation/localization based on market-savvy and intercultural expertise
    • Translation of documents, brochures, marketing and communications content into European languages
    • Strategies, project management, management of agencies and service providers, marketing controlling
    • Working with our clients’ online marketing systems
    • Analysis of the market and competition
    • Desk research
    • Development and implementation of market and customer surveys
    Development and implementation of overseas campaigns for European markets
    Your "Extended European Export Department"
    Market positioning
    Authorized Representative

    European law requires companies marketing medical devices within the European union, to have a registered place of business in a Member State or to designate a person(s) responsible to act as a European Authorized Representative who is(are) established in the Community. The European Authorised Representative must inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned.


    The main activities of an authorized representative include:

    • Pre-market phase: Advising non-European manufacturers in the pre-market phase on EU market entry requirements including forming a regulatory strategy, clarifying and assisting with classification , meeting the essential requirements, and conformity assessment to achieve CE marking
    • Post-market Phase: Acting as the main point of contact with competent authorities and notified bodies

    Due to possible conflict of interest with commercial objectives it may make sense not to use distributors as European Authorised Representatives.

    CE Marking

    Three directives the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC), the Medical Devices Directive (MDD) (93/42/EEC) and the In Vitro Devices Directive (IVDD) (98/79/EC), provide the legislative framework within which Member State Competent Authorities and Notified Bodies regulate the so-called European Conformity or Conformité Européenne (CE) marking process. This is a legally binding statement by the manufacturer that the products being placed on the market meet all the essential requirements as described in the annex of the above mentioned directives.