3030 Auditorium 01/04 - DEKRA Certification

MEDICAL DEVICES
Advance agreement on
specific aspects
Re-labelling an existing product is clearly
the least of the problems here. None of
the other key parts of the product
creation process, however, is managed
by the private label manufacturers themselves.
In order to comply with medical
device law it is therefore imperative to
Internet download
(only available in German):
■ www.zlg.de
■ “Download”
■ “Antworten und Beschlüsse des
Erfahrungsaustauschkreises der
nach dem Medizinproduktegesetz
benannten Stellen (EK-Med)”
■ Document 3.09 A 5: “Auditierung
von Subunternehmern –
Zertifizierung von OEM Produkten”
Your contact regarding
further questions:
Jürgen Bozler
DEKRA-ITS
Certification Services GmbH
Tel. +49.711.78 61-27 78
juergen.bozler@dekra-its.com
Conformity of
OEM products
To remain competitive, sales organisations, retailers and medical device manufacturers
often buy ready-made medical devices from OEM producers and
then distribute them under their own name as “private label manufacturers”
(also known as “quasi-manufacturers”). What impact does this have on conformity
audit as defined in the 93/42/EEC Medical Device Directive?
include all the relevant pre-production
and manufacturing stages in the conformity
assessment procedure. A final
examination by the appointed Notified
Body is only possible if responsibilities
have been clearly defined between the
OEM producer and the private label
manufacturer.
The scope of the actual conformity requirement
here pivots on the certification
status of the product concerned and on
approval of the OEM producer’s quality
assurance system. Typical scenarios are
described by the official ZLG accreditation
body (appointed accreditation
authority in Germany) in its eight-page
“Auditing of Sub-contractors – Certification
of OEM Products” document
which can be downloaded from the
Internet (see box).
Responsibilities on both
sides
Under the terms of medical device law,
the overall manufacturing responsibility
lies with the private label manufacturer.
He cannot therefore transfer all responsibilities
to the OEM producer. It is, however,
possible to divide up the obligations
arising from the existing quality management
systems between the two partners
in the form of a “list of responsibilities”.
Also,responsibilities for stipulations in
the Medical Device Directive such as the
following are to be defined in a binding
agreement:
■ Generation/approval of instructions
and labelling
■ Generation, approval and updating
of technical documentation:
“Basic requirements” checklist
(Appendix I of 93/42/EEC Directive),
documentation of clinical assessment
and risk analysis, regulations on
location/availability of technical
documentation
■ Sterilisation process validation
(where applicable)
■ Subcontractors of the OEM producer
■ Monitoring/reporting system
(vigilance)
■ Other special national requirements
The “list of responsibilities” provides
exclusive specification of the implementation
responsibilities which must be
accepted in order to fulfil the manufacturing
obligations. A written agreement
also regulates the aspects which
the private label manufacturer cannot
fulfil by himself. This OEM agreement
is always checked and evaluated by the
Notified Body. Examples for the precise
contents of the agreement can be seen
in the ZLG document mentioned above.
The download information is given on the
left.