© obelis s.a. 2013 code of conduct of authorised representative services under the council...
TRANSCRIPT
© Obelis s.a. 2013
CODE OF CONDUCT
of Authorised Representative services under the Council Directive 93/42/EEC, Directive 98/79/EC
and Council Directive 90/385/EEC
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© Obelis s.a. 2013
Presentation Structure
1. Definition
2. Main Changes
3. Purpose of the Code of Conduct
4. Chapters overview
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1. Code of Conduct definitionDefinition 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. (http://en.wikipedia.org/wiki/Code_of_conduct )
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))
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2. 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
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3. 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
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4. 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
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4. 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
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4. Qualification and Assignment
Availability, Knowledge & Confidentiality- availability during office hours- person responsible for regulatory compliance
Independency & Neutrality
QMS & Assessment- ISO 13485- CA assessments
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4. 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
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4. 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)
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4. 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)
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Obelis European Authorized Representative Center
(O.E.A.R.C.)Registered address:Bd. Général Wahis 53
1030 Brussels, Belgium
Registered office address:Av. de Tervueren 34 B 441040 Brussels, Belgium
Tel: +32 (0) 2 732 5954Fax: +32 (0) 2 732 6003E-mail: [email protected]
www.obelis.net 12