Code of Conduct version 2014-09-09
Basic principles
We recognise that the Commission's wish for a Code of Conduct is based on a perceived need to
police all authorised representatives, not just the members of EAAR. Consequently the Code is
available to all ARs, although signing it does not automatically imply membership in the EAAR.
However, adhering to the Code is an essential condition of being a member, although there will be
other requirements.
The implication of the above is that the Code should not contain any requirements that are specific
to EAAR membership.
There is an implication that the effect of the Code will be to put pressure on the EAAR to open up
the membership. However, this issue will be worked on as a separately from the Code of Conduct.
In developing the Code we must first consider requirements arising from the directives and the
interpretation of these requirements (the MEDDEV guidance document). The WG did complete that
review and therefore the bulk of the contents of the Code presented below has been inspired by
these sources.
At the moment we cannot be sure what the new Regulations will say about ARs. There is some
evidence that the review in the Council may result in substantial changes that may increase the
responsibilities of ARs significantly. Therefore the current version of the Code cannot cover the
requirements of the future Regulations.
We also agreed that we would try to initially build consensus on issues on which agreement is likely
to exist. We have therefore prioritised for instance the contract between the manufacturer and the
AR, access to the manufacturer's technical documentation and the qualifications of the AR whereas
we have deprioritised the verification and enforcement of the Code.
The text that would actually go into the Code is given in italics below. However, we need to
reconsider the style of the document by rereviewing similar codes (Notified Bodies, Reach) and
giving consideration to the Code of Conduct of being used in the future as the document against
which authorised representatives will be audited.
Additional work to consider
Consider also the Blue Guide & decision 768/2008/EC,
– Self-assessment questionnaire
An established (or QS customised for authorised representation) quality system that implements the
requirements of this Code of Conduct.
Best practices guide
WG consensus text so far
Introduction
TBD (this would explain the purpose of the Code. It would be best to write this once the main body
of the Code has been written).
It would include the following statements.
General requirements
The AR must be set up and operate in compliance with applicable European and national legal
requirements (Add legal and MEDDEV references). The primary role of an authorised representative
(AR) is to provide the competent authorities with a contact person established in the Community,
particularly in cases of emergency (Ref Recital 16 (MDD), Recital 14 (Directive 2007/47/EC), and
Recital 29 (IVDD). In addition, ARs may be requested by manufacturers to assist the manufacturer in
achieving and maintaining compliance with regulatory requirements.
ARs and their personnel shall carry out their activities with a high degree of professional integrity and
the requisite technical competence in the specific field and shall refrain from and seek to avoid
conflicts of interest of a business or financial nature.
. ARs shall not engage in anti-competitive actions. [Not sure what is meant to be in the CoC and
what is not here - italics vs non-italics]
ARs should further the interests of the authorised representatives within the European
Economic Area by advocating such interests to the European Commission, authorities of the
Member States and other interested parties.
Contract between the manufacturer and the AR
The requirement that the AR is "explicitly designated by the manufacturer" should be understood as
meaning that there shall be a mutually agreed written contract that clearly describes the
responsibilities and rights of the AR in relation to the manufacturer's regulatory compliance
obligations.
The contract should contain at least the following elements:

Description of the following operational modalities:
o Rapid access to manufacturer’s up-to-date technical documentation and information
requested by a CA.
o Corrective action to eliminate the risks posed by devices.
o Informing the manufacturer when the AR becomes aware that an adverse incident
may have occurred or a new risk has emerged.
o Transmission of communications received from users, Competent Authorities and
third parties relating to the medical devices represented.
o Provision of information by the manufacturer to the AR in all matters that may be
connected to the devices placed on the market in the EU. At the minimum this must
cover information on requests for information from CAs and action taken by them as
o
o
o
o

well as information received on suspected adverse incidents that the AR would not
be aware of otherwise.
Terms covering the duration, amendments to and termination of the contract,
including provisions covering the possibility that one of the parties ceases operations
covered by the contract.
Approach to be taken when a CA intends to carry out enforcement action and/or
when a CA requests the AR directly to take corrective action related to the
manufacturer’s products, e.g. requesting the AR to carry out a recall.
Dispute resolution.
Change of authorised representative, including transfer of contract to another party.
Confirmation that the manufacturer will provide access to all relevant technical
documentation needed for the fulfilment of the tasks of the authorised representative1,
which may include2, but not be limited to
o Declaration of conformity
o Copy of the label, packaging and instructions for use (in all languages requested by
the countries where the device is marketed),
o Notified Body certificates (where relevant),
o Post market surveillance process and data, vigilance reports and complaints,
processes and data,
o Technical documentation relevant to market surveillance investigation being
undertaken by the Member State,
o Relevant clinical data / notification,
o Details of any distributors / suppliers putting the CE marked devices on the market,
o Incident reports and reports on corrective actions taken.
Operations of an AR
The AR should establish that there is evidence of compliance by the manufacturer (e.g. declaration of
conformity as well as NB certificates or for Class I devices the availability of an Essential
Requirements checklist and a clinical evaluation report) when inducting a new client and verify this
periodically especially when the manufacturer introduces a new product.
The AR should warn clients of any actual or potential regulatory and legal violations that
may result from their activities or plans.
1
This may be specified as an actual list of documents, or by reference to MEDDEV 2.5/10 “GUIDELINE FOR
AUTHORISED REPRESENTATIVES”
2
Include ref to MEDDEV
The AR shall terminate the contract if the manufacturer acts contrary to his obligations under the
regulatory requirements. The AR shall then notify his Competent Authority and the manufacturer’s
Notified Body of this.
ARs are bound to observe confidentiality with regard to all information obtained in carrying out their
tasks, except when required to disclose such information by law
ARs shall contract for sufficient liability insurance pertaining to Authorised Representative
activities, in order to protect their clients and themselves
Maintain good relationships with Competent Authorities, and be responsive to their
enquiries.
Capabilities of an AR
The AR shall be able to assess manufacturer’s technical documentation and determine if it provides
sufficient substantiation of compliance;
The AR shall have available
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At least one person responsible for regulatory compliance who possesses the requisite expertise
in the field of medical devices in the Community. This person will have a diploma, certificate or
other evidence of formal qualification awarded on completion of a university degree or of an
equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or
another relevant discipline.
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At least one staff member with more than 5 [or 3?] years of proven medical device regulatory
experience. Staff should have knowledge and experience of the European regulatory system for
the products covered by the mandate.
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Seek and follow further education in areas relevant to Authorised Representatives as
well as maintain awareness of relevant developments.
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Sufficient communication capability to meet its obligations under the contract with the
manufacturer, to be capable of processing in a timely fashion any requests from CAs and to
react to any external communications that imply that an adverse incident may have occurred
or that a new risk has emerged.
ARs shall be incorporated as a legal person and assume all the legal responsibilities
that this entails. [Again, not sure what is meant to be in the Code here]
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The AR should be set up in such a fashion that a CA can easily contact it and interact with it.
The address of the AR should be provided with medical devices placed on the Community
market by its contracted manufacturers in accordance with the specific requirements of the
directive concerned and in conformity with EN 1041. The address used shall be the place of
business where the AR is physically located.
Verification of compliance with the Code of Conduct
Signatories of the Code of Conduct attest by their signatures that they comply with the Code.
Additional work to consider
Consider also the Blue Guide & decision 768/2008/EC,
– Self-assessment questionnaire
An established (or QS customised for authorised representation) quality system that implements the
requirements of this Code of Conduct.
Best practices guide