© Obelis s.a CODE OF CONDUCT of Authorised Representative services under the Council Directive 93/42/EEC, Directive 98/79/EC and Council Directive 90/385/EEC 1

© Obelis s.a Presentation Structure 1. Definition 2. Main Changes 3. Purpose of the Code of Conduct 4. Chapters overview 2

© Obelis s.a Code of Conduct definition Definition 1: A Code of conduct is a set of rules outlining the responsibilities of or proper practices for an individual or organisation. Related concepts include ethical codes and honour codes. ( ) Definition 2: Principles, values, standards, or rules of behavior that guide the decisions, procedures and systems of an organization in a way that (a) contributes to the welfare of its key stakeholders, and (b) respects the rights of all constituents affected by its operations.“ (International Good Practice Guidance, Defining and Developing an Effective Code of Conduct for Organizations, (2007))

© Obelis s.a Main changes  Incorporation of new proposal Regulation requirements for AR (COM(2012) 542 final/2012/0266 (COD))  More detailed and explicit due to the enforcement of AR’s role by recent law revisions  Introduction of clear procedures of assessment  Mandatory to all EAAR Members

© Obelis s.a Purpose of the Code of Conduct  to establish a common set of minimum required standards  to define rules on qualification of work and personnel  to ensure a harmonized quality of work amongst the participating AR  assure high quality of service and high ethical standards

© Obelis s.a Implementation and monitoring  AR QMS in compliance with Code of Conduct  Implementation of Code within 6 months upon signature  Assessment procedure via two external auditors  Criteria and procedure for dismissing existing members

© Obelis s.a Nature of Authorised Representatives  Definition of AR  Registered place (legal entity) and availability during all working days  1 AR per generic device group  AR with EUDAMED authorization code

© Obelis s.a Qualification and Assignment  Availability, Knowledge & Confidentiality - availability during office hours - person responsible for regulatory compliance  Independency & Neutrality  QMS & Assessment - ISO CA assessments

© Obelis s.a Role and responsibilities  AR to assess the manufacturer’s ability to fulfill his regulatory obligations  AR to verify if product falls under medical device definition  AR to review conformity of technical documentation (listed i-viii)  AR to rescind the contract in case of manufacturer’s non compliancy  AR to inform CA and NB accordingly

© Obelis s.a Mandate  The mandate must allow and require the authorised representative to perform all tasks mentioned in art. 9 par. 3 of the proposal  Other tasks also mentioned, derived from manufacturers regulatory obligations (Directive, MEDDEV, proposal of Regulation)

© Obelis s.a Rules for Certification  Guidelines on Certification  Technical documentation overview certifies what AR reviewed at the time being (signature date); the AR holds no responsibility in case of any later modification by the manufacturer (same as pre-market notification documentation)

© Obelis s.a Obelis European Authorized Representative Center (O.E.A.R.C.) Registered address: Bd. Général Wahis Brussels, Belgium Registered office address: Av. de Tervueren 34 B Brussels, Belgium Tel: +32 (0) Fax: +32 (0)