Answers and Resolutions by EK-Med

Conformity Assessment 3.9 B 16

Zentralstelle der Lnder fr Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Sebastianstrae 189 53115 Bonn Germany
Telefon +49 228 97794-0 Fax +49 228 97794-44 E-Mail zlg@zlg.nrw.de Website www.zlg.de
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Certification of OEM Devices
Often identical medical devices are placed on the market under different manufacturers' names,
although a single producer makes them. In such cases the company under whose name the
device is placed on the market does not control large parts of the devices design and
manufacturing process. Dealers or sales organisations who place medical devices on the
market under their own name are, however, manufacturers in the meaning of the Medical
Devices Directives and must conduct a corresponding conformity assessment procedure
regardless of what influence they have on the development and/or production of the devices. In
such cases the Notified Body will only be able to audit a few aspects of the conformity
assessment procedure selected directly at the manufacturer's premises in the meaning of the
Directives.
If Original Equipment Manufacturers (OEM) carry out relevant design or manufacturing steps,
the Notified Body must include these steps in the assessment. This arises from the provisions of
Medical Devices Directives.
The extent to which the OEM is being involved in the conformity assessment procedure for the
private label manufacturer (PLM) is mainly dependent on whether and on which basis
certificates exist for the OEM respectively his quality management system or products and by
which body these certificates were issued.
The different possible scenarios are described in this document.
1 Definitions
The following definitions apply for the following remarks:
Private Label Equivalent to trade name
Private Label Manufacturer (PLM) Company that appears as manufacturer in the meaning of
the Medical Devices Directives, but does not itself produce
(often also called "quasi manufacturer").
The devices are not modified by the Private Label
Manufacturer, or only slightly; normally they are only
purchased, stored and sold under his own name.
OEM Original Equipment Manufacturer; Company that produces
the finished device for a Private Label Manufacturer and in
this case does not appear as the manufacturer in the
meaning of the Medical Devices Directives.
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2 Possible scenarios
The following are the possible scenarios when certifying OEM devices, i.e. devices sold by a
PLM under his own name, but not produced by him:
A OEM is himself also manufacturer in the meaning of the Medical Devices Directives for
the relevant device and accordingly certified by a Notified Body under the relevant
Directive. Depending on the class of the medical device and on the conformity
assessment procedure chosen by the OEM different constellations have to be
distinguished:
A 1 The quality assurance system of the OEM has been certified according to Annex
II, V or VI, but a product certification according to Annex II (4) or III is not required
A 2 The quality assurance system of the OEM has been certified according to Annex
II (3) and his product according to Annex II (4)
A 3 The quality assurance system of the OEM has been certified according to Annex
V or VI and his product according to Annex III
A 4 The quality assurance system of the OEM has not been certified, i.e. conformity
assessment procedure according to Annex III combined with IV, or VII combined
with IV.
B OEM does not operate with respect to this device as manufacturer in the meaning of the
Directives and is certified according to EN ISO 13485 : 2003
1
. This certification has to be
granted by a body authorised for this product/group of products by an authority
competent for the designation of Notified Bodies according to Directive 93/42/EEC in
Germany accreditation by ZLG.
C OEM does not operate as manufacturer in the meaning of the Directives and is not
certified according to EN ISO 13485 : 2003.
3 Description of areas of responsibility
The PLM must fulfil the requirements of Directive 93/42/EEC. A part of the tasks may be
transferred to the OEM, whereas the total responsibility remains with the PLM.
Invariably the PLM must explain to the Notified Body in the context of the conformity
assessment which activities/tasks he himself performs in the devices design and manufacturing
process and which are performed by the OEM (e.g. "List of Responsibilities").
This can be done, for example, by a listing of the quality management aspects based on EN
ISO 13485 : 2003. EN ISO 13485 : 2003 thereby also includes the relevant aspects of the
Medical Devices Directives as well as additional national requirements.
Within a conformity assessment procedure according to Annex II (3) of Directive 93/42/EEC the
PLM may not transfer the following aspects of his quality management system to the OEM
2
.
These aspects have to be audited by the Notified Body. The respective requirements apply as
well within a procedure according to Annex V of Directive 93/42/EEC.



1
The inclusion of the harmonised standard EN 46003 : 1999 into EN ISO 13485 : 2003 is currently being
prepared.
2
The list of the aspects of the quality management system is based on the structure of the EN ISO
13485 : 2003.
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Aspects of the quality management system Provision by PLM mandatory
Quality management system
General requirements
X
Documentation requirements
X (including regulations for preparation, approval and
maintenance as well as location and availability of
technical documentation, including list of Essential
Requirements and determination of responsibilities for
particular aspects)
management of OEM certificates (timely request for
succeeding certificates and check of content of
certificates)
Management responsibility X
Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority and communication
Management review
Resource management X (at least regulations concerning the activities at the
PLM and description of the interface with the OEM)
Provision of resources
Human resources
Infrastructure
Work environment
Product realization

Planning of product realization
X (at least planning of PLM concerning product
realization at OEM)
including execution and documentation of risk
analysis/risk management
Customer-related processes
X
Design and development
X
for procedures according to Annex II (3) of Directive
93/42/EEC at least a system for the design and
development of OEM products (with at least
determination of specifications, verification and
validation of such products, including execution and
documentation of clinical evaluation)
system for preparation and approval of instruction for
use and labelling
Purchasing
X
Production and service provision
X (at least regulations for identification and
traceability)
Control of monitoring and measuring devices
X (at least regulations concerning the activities at the
PLM)
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Measurement, analysis and improvement
General
X
Monitoring and measurement
X (at least regulations concerning vigilance
respectively feedback and internal audit)
Control of nonconforming products
X
Analysis of data
X
Improvement
X (at least corrective and preventive actions)
4 Minimum documentation to be submitted
Depending on the certification of the OEM (cases A, B, C), different documents must be
submitted as minimum documentation or different aspects must be regulated in the agreement
between OEM and PLM in the conformity assessment procedure for the PLM (see also 5).
4.1 Minimum documentation in case A
The OEM also operates as manufacturer in the meaning of the Medical Devices Directives for
the device concerned and is certified accordingly under the relevant Medical Devices Directive
by the Notified Body.
A 1 The quality assurance system of the OEM has been certified according to Annex II,
V or VI, but a product certification according to Annex II (4) or III is not required
In this case, the Notified Body has to be provided with the following documents
Application of the PLM for the conduct of a conformity assessment procedure
Regulation of re ponsibilities, e.g. in the form of a "List of Responsibilities"
Documented quality management system of the PLM
Declaration of conformity of the PLM
Valid certificate(s) according to the relevant Medical Devices Directive of the OEM
Declaration of conformity of the OEM that the OEM device and Private Label device
are identical/are identical except for ....
Labelling/instruction for use of the Private Label device (including intended use and
limitation of use) to compare with the requirements of the relevant Directive and with
the information from the OEM
Labelling/instruction for use of the OEM device already approved (including intended
use and limitation of use)
Regulation between OEM and PLM (see 5)
Technical documentation part A [1].
A transfer of the conformity assessment procedure according to Annex II for class IIb
products to a procedure according to Annex III combined with Annex V or VI is only
possible if the PLM additionally conducts a procedure according to Annex III for these
products.
A transfer of the conformity assessment procedure according to Annex II for class IIb
products to a procedure according to Annex III combined with Annex V or VI is only
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possible if the PLM additionally conducts a procedure according to Annex III for these
products.
If the OEM holds a certificate according to Annex V for the product in question (for
products of class IIa in combination with Annex VII, for products of class IIb and III in
combination with Annex III), the product may be included in the scope of an already
existing certificate of the PLM according to Annex II. In doing so, it must be assured that
the PLM has established a system for the design and development of OEM products and
has applied this system to the product in question. The system of the PLM for the design
and development of OEM products must at least comprise the determination of the
specifications, the verification and the validation of such products.
A 2 The quality assurance system of the OEM has been certified according to Annex II
(3) and his product according to Annex II (4)
In addition to the documents mentioned under A 1, the PLM has to provide or to be
provided
the report on the EC type-examination from the Notified Body of the OEM which has
to include the examination of the technical documentation
a comprehensive documentation out of which the Notified Body can see the changes
of the PLM product compared with the OEM product
on demand, the complete technical documentation of the OEM.
Since these changes are normally restricted to labelling/instruction for use and/or
appearance, labelling/instruction for use and accompanying documentation have to be
checked as a matter of principle. Before issuing an EC design-examination certificate the
Notified Body of the PLM has to check at least identity and plausibility. Since the Notified
Body is fully responsible for the issued certificates, it has to assure that all documents
relevant for assessment are available and that the decision to issue a certificate is
traceable on the basis of the available documents. This may require inspection of the full
technical documentation of the OEM.
To prove the validity of the EC type-examination for the OEM product the document 3.9 B
15 [2] has to be applied accordingly.
In any case, the EC design-examination and the assessment of the quality assurance
system of the PLM have to be conducted by the same Notified Body (modules may not be
split).
A transfer of conformity assessment procedures according to Annex II (3) and II (4) for
class III products to procedures according to Annex III and V is only possible if the PLM
additionally conducts an EC type-examination (Annex III) for these products.
A 3 The quality assurance system of the OEM has been certified according to Annex V
or VI and his product according to Annex III
In addition to the documents mentioned under A 1, the PLM has to provide or to be
provided
the report on the EC type-examination from the Notified Body of the OEM which has
to include the examination of the technical documentation
a comprehensive documentation out of which the Notified Body can see the changes
of the PLM product compared with the OEM product
on demand, the complete technical documentation of the OEM.
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Since these changes are normally restricted to labelling/instruction for use and/or
appearance, labelling/instruction for use and accompanying documentation have to be
checked as a matter of principle. Before issuing an EC type-examination certificate the
Notified Body of the PLM has to check at least identity and plausibility. Since the Notified
Body is fully responsible for the issued certificates, it has to assure that all documents
relevant for assessment are available and that the decision to issue a certificate is
traceable on the basis of the available documents. This may require inspection of the full
technical documentation of the OEM.
To prove the validity of the EC type-examination for the OEM product the document 3.9 B
15 [2] has to be applied accordingly.
Alternatively, the Notified Body of the OEM may issue the EC type-examination certificate
for the PLM. Again, a check of at least identity and plausibility is necessary.
The Notified Body of a PLM may derive an EC design-examination certificate for a class III
product from the EC type-examination certificate of the OEM if the quality assurance
system of the PLM has been certified according to Annex II (3) for the respective group of
devices. Again, the Notified Body has to check labelling/instruction for use and
accompanying documentation as well as identity and plausibility.
A 4 The quality assurance system of the OEM has not been certified, i.e. conformity
assessment procedure according to Annex III combined with IV or VII combined
with IV
Regarding EC type-examination see A 3.
The EC verification according to Annex IV has to be conducted by the manufacturer in the
meaning of the Medical Devices Directives, i.e. the PLM, as a matter of principle. An OEM
situation as described in this document does not exist.
This means, the Notified Body always must carry out the appropriate examinations and
tests in order to verify the conformity of the product with the requirements of the Directive.
With this, the Notified Body checks according to the regulations laid down in Annex IV
whether the products conform to the type described in the EC type-examination certificate
respectively the technical documentation.
4.2 Minimum documentation in case B
The OEM does not operate as manufacturer in the meaning of the Medical Devices Directives,
but is certified according to EN ISO 13485 : 2003.
Application of the PLM for the conduct of a conformity assessment procedure
Regulation of the responsibilities, e.g. in the form of a "List of Responsibilities"
Documented quality management system of the PLM
Declaration of conformity of the PLM
Valid certificate of the OEM according to EN ISO 13485 : 2003. This certification has to be
granted by a body authorised for this product/group of products by an authority competent
for the designation of Notified Bodies according to Directive 93/42/EEC in Germany
accreditation by ZLG.
Labelling/instruction for use of the Private Label device (including intended use and
limitation of use)
Regulation between OEM and PLM (see 5)
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Technical documentation part A [1].
In addition, the OEM must be able to present an audit report for EN ISO 13485 : 2003, which
contains information showing that appropriate evidence/information is available for all
activities/devices delegated to the OEM in accordance with the list of responsibilities.
If these aspects are not included in an audit report, the evidence of the effectiveness of the
OEM's quality management system with specific reference to the device concerned can also be
provided in the form of supplementary comments by the certification body.
If the aforementioned evidence is not available, the procedure must be that described for case
C.
4.3 Minimum documentation in case C
The OEM does not operate as manufacturer in the meaning of the Medical Devices Directives
and is not certified according to EN ISO 13485 : 2003.
In such a case the Notified Body must conduct a subcontractor audit because the conduct of a
conformity assessment procedure is not only possible on the basis of the documentation
submitted (please compare also introduction on page 1).
The PLM must be able to submit at least the following documents:
Application of the PLM for the conduct of a conformity assessment procedure
Regulation of the responsibilities, e.g. in the form of a "List of Responsibilities"
Documented quality management system of the PLM
Declaration of conformity of the PLM
Labelling/instruction for use of the PLM device (including intended use and limitation of use)
Regulation between OEM and PLM (see 5)
Technical documentation part A [1].
5 Contents of the agreement
The PLM must provide evidence of detailed agreements with the OEM. In these agreements
precise and mandatory provisions must be made concerning all requirements of the relevant
Medical Devices Directive and of relevant national law, which the PLM cannot satisfy alone.
The items below will be checked and assessed by the Notified Body:
Scope of the agreement (devices/device groups concerned)
Period of agreement's validity
Detailed specifications for the respective devices
Regulations governing who is responsible for which documentation (technical
documentation, DHR (Device History Record) etc.) incl. retention periods
Traceability of raw material/components to PLM
Influence on device design by the PLM
Regulations governing the procedure by which changes to the device and in the
manufacturing process are initiated, released, implemented and documented
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Right for the Notified Body and the Competent Authority of the PLM to examine the technical
documentation
Regulations governing collaboration in the case of incidents/mandatory notification/recall
Regulations governing access of Notified Bodies and Competent Authorities to the OEM' s
premises and those of his suppliers/subcontractors
Obligation to provide information where there are changes to the status of the certificates of
the OEM and/or PLM
Dealing with customer complaints
Where relevant, responsibility matrix (see above)
The regulations of this document also apply to the scope of Directive 98/79/EC.


Reference 93/42/EWG Article 11 and Annexes II-VII
MEDDEV 2.5/3 rev. 2 Subcontracting Quality Systems related
[1] NB-Med/2.5.1/Rec. 5 Technical Documentation
[2] 3.9 B 15 EG-Auslegungsprfung, EG-Baumusterprfung
Verlngerung der Geltungsdauer von Bescheinigungen
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Keywords manufacturer, conformity assessment, OEM, Private Label Manufacturer,
supplier
Date of issue J anuary 2007; replaces document 3.9 A 5; corrected J une 2007


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