Get Endorsed

Become a Best Economic Operator

Who can apply

Best Economic Operator endorsement is open to:

  • Authorised Representatives

  • Importers

  • Distributors

Applicants must be actively operating within the EU medical device regulatory framework, carrying out their legal responsibilities in line with MDR or IVDR expectations.

Becoming a Best Economic Operator means demonstrating regulatory competence in practice - not just in theory.

Apply Here

What the Assessment Focuses On

The Best Economic Operator assessment looks beyond policies and claims.

It evaluates how regulatory responsibilities are actually carried out in practice.

The aim is not to judge intent, but to verify performance.

Assessment criteria include:

  • Demonstrated regulatory competence

  • Documented and maintained processes

  • Understanding of MDR / IVDR obligations

  • Vigilance and communication capability

  • Ability to respond effectively in regulatory situations

How the Endorsement Process Works

  • 01

    Initial enquiry
    Submit an enquiry to confirm eligibility and scope.

  • 02

    Assessment scheduling
    A remote assessment is arranged at a mutually agreed time.

  • 03

    Independent assessment
    Regulatory responsibilities are reviewed against defined best-practice criteria.

  • 04

    Outcome and feedback
    You receive a written outcome, including any recommendations.

  • 05

    Endorsement and listing
    Successful applicants are listed as Best Economic Operators.

Apply Here

Code of conduct

Best Economic Operator endorsement is earned, independent, and evidence-based. It is not a membership, self-certification, or marketing badge.

All endorsed operators commit to our Code of Conduct, which reflects the standards expected under EU medical device regulations:

  • Put patients first - safety, wellbeing, and accessibility always come first.

  • Be transparent - open, honest, and clear in all communications.

  • Act with integrity - objective, documented, and accountable processes.

  • Stay compliant - follow all applicable laws, regulations, and industry standards.

  • Respect & include - treat everyone fairly and foster a responsible, inclusive environment.

Read our full Code of Conduct

Ready to apply?

Fill out the form to start the Best Economic Operator endorsement process. We’ll be in touch to confirm the next steps.