Membership

A membership with EAAR includes the following benefits:

  • EAAR is the only professional trade association representing authorised representatives recognized 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).  EAAR is therefore consulted on all relevant draft guidance and policy documents before they are formally issued by the Commission and the MDCG.
  • As a member of EAAR, you will have the opportunity to contribute to the development of regulatory guidance and policy in the European Union.
  • You will be part of a community that shares your concerns and enables you to discuss them with your peers.
  • You will join a highly respected group that promotes professional experience and high standards of performance.
  • Finally, EAAR serves its members. If you have ideas on how to improve the business environment as an authorised representative, EAAR will provide the framework that may enable it to happen.

Membership types

Membership fees

The same fees apply to both Full and Associate memberships.

Number of employeesAnnual membership fee
Up to 3500€
4 to 9670€
10 to 29900€
30 to 591250€
60 and more1650€

Membership conditions

Full members

(a) 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).

(b) Must represent at least 10 (ten) manufacturers as Authorised Representative.

(c) 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.

(d) Must be registered for VAT.

(e) Must have at least one permanent employee with one of the following qualifications :

i. 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

ii. Four years of professional experience in regulatory affairs or quality management systems related to medical devices ;

(f) Be covered by liability insurance;

(g) Have notified their activity as an Authorized Representative to their relevant competent authority (Eudamed, if applicable) ;

(h) Sign the Code of Conduct and a declaration confirming that the above conditions are met.

Associate members

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

(a) Have at least 4 years experience in the field of medical devices.

(b) Have worked with at least 10 (ten) customers.

(c) 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.

(d) Have at least one permanent employee with one of the following qualifications :

i. 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

ii. Four years of professional experience related to medical devices;

(e) Be covered by civil liability insurance ;

(f) Sign the Code of Conduct and a declaration confirming that the above conditions are met.

Inelegibility

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.

Apply now

To apply for a membership, please complete the form below. We will get back to you as soon as possible.

    1 — General company and contact information

    Company

    Company name*

    Company address*

    Company phone*

    Company e-mail*

    Company website*

    President, Managing director or equivalent

    President name*

    President phone*

    President e-mail*

    if different: Person responsible for Authorised Representative services

    Representative name

    Representative title

    Representative phone

    Representative e-mail

    Company structure and organisation

    Legal form*

    Number of employees*

    VAT and commercial reg no.*

    Subsidiary of / independent*

    2 — Please tell us more about your activities as Authorised Representative.

    Number of persons involved in authorised representative activities

    Activities of authorised representative in the medical device field for at least 3 years?*
    YesNo

    Are you working for at least 10 medical devices manufacturers as their European authorised representative?*
    YesNo

    Are you a registered legal entity?*
    YesNo

    Do you have available at least one staff member with more than 4 years of regulatory experience in the field of medical devices?*
    YesNo

    Do you have available at least one permanent staff member with a degree in law, medicine, pharmacy, engineering or other relevant scientific discipline?*
    YesNo

    Is your authorised representative activity covered by liability insurance?*
    YesNo

    Have you notified your relevant Competent Authority about your authorised representative activities?*
    YesNo

    3 — Further activities

    What further services do you provide?*
    Distribution/marketingRegulatory consultingQuality systems/auditingClinical investigation servicesReimbursement consulting

    If you provide other services, please specify them. Otherwise, type "No".*

    4 — More information

    How did you learn about EAAR?*

    What are your motives for participating in EAAR?*

    What do you wish to achieve by participating in EAAR?*

    5 — Comments

    Would you like to add anything?

    6 - Legally binding signature

    By submitting this form, I certify that the above information is complete and accurate and that the financial situation of the company identified under question is sufficient to warrant uninterrupted authorised representative services to customers for the foreseeable future. I allow a neutral agent to verify any information represented above, without divulging Company confidential information to EEAR. I understand that if I provide false or misleading information, the membership of my Company in EAAR may be terminated immediately upon discovery of this fact. If accepted as a member I and my company agree to act in accordance with the EAAR Code of Conduct and comply with the Articles of Association of the EAAR.

    Name, title, date and place*

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