Membership

Join Europe’s only professional trade association representing authorised representatives, and shape the regulatory frameworks.

Exclusivity

We are the only professional trade association representing authorised representatives recognised by the European Commission as stakeholder. This gives access to stakeholder briefings by the Commission and to the expert groups set up under the Medical Device Coordination Group (MDCG). The EAAR is therefore consulted on all relevant draft guidance and policy documents before they are formally issued by the Commission and the MDCG.

Contribute

Members of the EAAR contribute to the development of regulatory guidance and policy in the European Union.

Network

Join a network that shares your concerns and enables you to discuss them with other parties and stakeholders.

Reputation

The EAAR is a highly respected group that promotes professional experience and high standards of performance.

Foster change

Finally, we listen to our members. If you have ideas on how to improve the business environment as an authorised representative, the EAAR provides the framework that makes it happen.
Membership types

We offer two types of memberships. See below for fees and eligibility.

Full membership

Our full membership, which among other things grants voting rights, is only available to companies that fulfil the below criteria.

Apply
  • Participate in seminars organised by the EAAR as speakers
  • Draft association opinion papers
  • Be actively involved in deliberations during assembly meetings
  • Propose and vote on new members (two-thirds majority needed)
  • Avoid conflict of interest through their professional activities as well as considering their activities and their responsibilities within the Association
  • Responsible for any amendments of the Articles of Association
  • Vote on the Association’s vision and mission
  • Designation and removal of the Chairperson, Secretary-General and Treasurer (and the members of the Board of Directors)
  • Dissolution of the Association
  • Vote on Association opinion papers to be published
  • Draft Association opinion papers
  • Fiduciary duty – act reasonably, prudently, and in the best interests of the organization; to avoid negligence and fraud
  • Approval of the accounts and budgets, determination of annual fees
  • Be thoroughly prepared before meetings and before making decisions
  • Be actively involved in the Association’s activities, e.g., working groups, committees etc.
  • Abide to the Association’s code of conduct
  • Be actively involved in the development of processes and policies of the Association

Associate membership

Our associate membership provides numerous benefits, although it does not include voting rights.

Apply
  • Participate in seminars organised by the EAAR as speakers
  • Participate in the drafting of association opinion papers
  • Attend General Assembly meetings
  • Suggest members
  • Avoid conflict of interest through their professional activities as well as considering their activities and their responsibilities within the Association
  • May receive commission on suggested new members who are voted by the General Assembly to become members
  • Access to documents obtained by the Association (confidentiality to be considered)
Pricing

The same fees apply to both full and associate memberships, and are contingent on the number of employees.

Number of employees
Annual membership fee
Up to 3
500€
4 to 9
670€
10 to 29
900€
30 to 59
1250€
60 and above
1650€
Eligibility

Each membership has its own conditions

Full membership conditions

  • The activities must be at least partially devoted to authorised representation (a minimum of 3 years experience as an Authorised Representative in the field of medical devices is necessary for this condition to be met)
  • Must represent at least 10 (ten) manufacturers as Authorised Representative
  • Must be a legal person duly registered in the territory of the European Union or of a country with which the European Union has concluded an agreement recognising Authorised Representatives resident there
  • Must be registered for VAT
  • Must have at least one permanent employee with one of the following qualifications
    • A diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study or recognized as equivalent by the Member State concerned in law, medicine, pharmacy, engineering or other relevant scientific discipline and at least one year’s professional experience in the field of regulatory affairs or quality management systems related to medical devices, or
    • Four years of professional experience in regulatory affairs or quality management systems related to medical devices
  • Be covered by liability insurance
  • Have notified their activity as an Authorized Representative to their relevant competent authority (Eudamed, if applicable)

Associate membership conditions

Any regulatory operator who is an expert in the field of medical devices and who fulfils the following conditions:

  • Have at least 4 years experience in the field of medical devices
  • Have worked with at least 10 (ten) customers
  • Be a legal entity duly registered in the territory of the European Union or of a country with which the European Union has concluded an agreement requiring the application of European Union regulations on medical devices in the country in question
  • Have at least one permanent employee with one of the following qualifications:
    • A diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study or recognized as equivalent by the Member State concerned in law, medicine, pharmacy, engineering or other relevant scientific discipline and at least one year’s professional experience related to medical devices; or
    • Four years of professional experience related to medical devices;
  • Be covered by civil liability insurance
  • Sign the Code of Conduct and a declaration confirming that the above conditions are met

Ineligibility

Members (Full and Associate) may not be manufacturers, importers, distributors or Notified Bodies as defined in the Regulations. However, the Board may accept such entities as observers, on a case-by-case basis and for a well-defined purpose.