EUAR Services
from MeddiQuest Limited
Welcome to the MeddiQuest website - your first stop on the path to CE Marking, 510(k) clearance, PMA / PDP Approval and ISO 13485 / ISO 14971 Quality Systems! Make Regulatory Compliance part of your Competitive Advantage!
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Our Mission is to provide all the support services necessary for your company to enter the European Market, and through simple and effective strategies
speed healthcare advances to market.

EU Authorized Representative services are provided by
MeddiQuest

Our Objective is to be your Single Source for European Market Entry supplying every service you will need to enter the European market, not just supplying the legal requirements of the EUAR.

From Translation Services to Market Research.

From Exhibition Planning to Product Support.

From Complaint Management to Finding a "European Warehouse".

Through our networks of specialist and local partners, we can to the organization for you!

The European Union is a family of democratic European countries, committed to working together for peace and prosperity. It is not a state or intended to replace existing states. The EU is unique because its Member States have set up common institutions to which they delegate some of their powers so that decisions can be made in member's joint interest.

Directives are issued to member states requiring them to adopt mutually agreed policies into their national laws. Many of these are about trade to ensure a "level playing field" for trading between member states, and a number of these establish the need for someone within the EU to act as a representative for a non-EU based manufacturer.

The Role of the EUAR (European Union Authorized Representative) is specified in several directives and simply establishes a legal entity within the EU who can act on behalf of the manufacturer.

Additional Services are generally required by a manufacturer to ease their entry into the complex European Trading Environment. At MeddiQuest we pride ourselves on having designed a service that does not just meet the minimum legal requirements but also can include a range of other services to help our customers make a painless entry into Europe.

There are five key EU Institutions: the parliament (elected), the council (nominated by governments of the member states), the commission (the executive), the courts of justice and the court of auditors.

Three key treaties comprise the Primary Legislation of the EU. The Single European Act (1987), The Treaty of the European Union, Maastricht Treaty (1992) and the Treaty of Amsterdam (1997, came into force 1999).

Secondary Legislation comprises: Regulations, Directives, Decisions and "Recommendations and Opinions".

The Tertiary Legislation, the acquis communautaire, consists of case law including judgements of the Court of Justice and the Court of First Instance.

EU Market EUAR Legal Requirements EUAR Options EUAR Services Contact Us
email us at info@meddiquest.com

The information given on this website is provided in good faith, however it should not be used in any regulatory or other context without reference to the current legislation and regulation.

Every precaution has been taken to ensure the accuracy of content; however, we can not accept responsibility for the correctness of the information supplied, any advertising claim or opinion expressed.

It is good regulatory practice never to act on the basis of any secondary information, but to always refer to publications by the regulatory agencies. Many publications are now available on line.

Uploaded March 14, 2005 - Last updated April 12, 2005
MeddiQuest Limited: Incorporated in England under number 4226188 at 116-SG8 9DY