Guidance on CE Marking for Professionals(in vitro Diagnostic Medical Devices & Medical Devices)
Guidance on CE Marking for Professionals
(in vitro Diagnostic Medical Devices & Medical Devices)
in vitro Diagnostic Medical Devices
Directives
As a first step, you need to verify whether your product(s) fall(s) within the definition of an in vitro diagnostic Medical Device (IVD) in accordance with Article 1 paragraphs 2a), 2b) and 2c) of Directive 98/79/EC. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 5 are applicable. If all these conditions are fulfilled, Directive 98/79/EC applies.
Download Directive 98/79/EC on in vitro diagnostic Medical Devices
For further information on in vitro diagnostic Medical Devices, please also visit the DG ENTR website dedicated to this sector by following this link:
http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm For a closer look at the list of harmonised standards, please visit
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislat ion/list-references/iv-diagnostic-medical-devices/index_en.htm
Verify Requirements
The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.
However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or on environment) may apply.
Directive 98/79/EC on in vitro diagnostic Medical Devices (IVDs) specifies general requirements the product must meet in order for the manufacturer to affix the CE marking. These requirements, known as Essential Requirements, are listed in Annex I of the IVD directive.
For a detailed overview, please consult Directive 98/79/EC.
Need for Notified Body?
Before proceeding with the assessment procedure, it is important to determine whether you, as a manufacturer, need to involve a Notified Body.
The involvement of a Notified Body is necessary for IVDs listed in Annex II to Directive
98/79/EC and for IVDs designed for self-testing. To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO– the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.
Check Conformity
The stringency of the conformity assessment procedures depends to which list of Annex II to Directive 98/79/EC the in vitro diagnostic Medical Device belongs. For each list, the manufacturer has the choice between two or three conformity assessment procedures. Each of the conformity assessment procedures consist of the application of one or more Annexes out of Annexes III to VII of the directive.
For all IVDs listed in List A or List B of Annex II to Directive 98/79/EC, the Notified Body verifies the design of the Medical Device and its compliance with the Essential Requirements. Also, in most cases, the Notified Body verifies the quality management of the manufacturer. In the case of IVD mentioned in List A of Annex II, the verification is complemented by a "batch release verification". Alternatively, when requested by the manufacturer, the Notified Body verifies, the compliance of the final product with the tested type. The Notified Body issues a certificate that indicates what has been verified by referring to one of the Annexes III to VI of the directive.
If the in vitro diagnostic Medical Device is not on any of the lists located in Annex II to Directive 98/79/EC, no involvement of the Notified Body is necessary unless the Medical Device is designed for self-testing. In this case, only the design of the Medical Device is examined by the Notified Body, unless the manufacturer requests a complete examination as outlined in the previous paragraphs.
Whether the involvement of a Notified Body is necessary or not, the manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, the identification number of the Notified Body if applicable, as well as a legally binding signature on behalf of the organisation.
Technical Documentation
Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity
of the appliance with the requirements of the Directive.
The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.
Affix CE Marking
Once the necessary steps have been successfully completed, the CE marking must be affixed to the in vitro device. The CE marking must be placed visibly and legibly on the device or, if not possible, affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:
The various components of the CE marking must have the same vertical dimension, which may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.
When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.
If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.
Medical Devices
Directives
As a first step, you need to verify whether your product(s) fall(s) within the definition of a Medical Device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active implantable Medical Device (Directive 90/385/EEC) or of an in vitro diagnostic Medical Device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article
of Directive 93/42/EEC is applicable. If all these conditions are fulfilled, Directive 93/42/EEC applies.
Download Directive 93/42/EEC on Medical Devices (MDD)
For further information on Directive 93/42/EEC on Medical Devices (MDD), please visit the DG ENTR webpage dedicated to this sector by following this link:
http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm For a further look at the guidance for Medical Devices, please visit:
http://ec.europa.eu/enterprise/sectors/medical-devices/regulatory-framework/index_en.htm
Verify Requirements
The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.
However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or environment) can apply.
Directive 93/42/EEC on Medical Devices (MDD) specifies general requirements that the product has to meet in order for the manufacturer to affix the CE marking. These are the so-called Essential Requirements that are listed in Annex I to the MDD. Compliance with the essential requirements must be demonstrated by a clinical evaluation in accordance with Annex X to Directive 93/42/EEC.
Need for Notified Body?
Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
In the Directive on Medical Devices, the Medical Device is classified in accordance with the provisions of Annex IX of the MDD as class I (low risk), class IIa or IIb (medium risk) or class III (high risk). The involvement of a Notified Body is not necessary for Medical Devices of class I unless they have a measuring function or are placed on the market in a sterile condition.
A Notified Body verifies in most of the cases only the quality management of the manufacturer.
For all Medical Devices belonging to class III, and for Medical Devices belonging to class IIa and IIb on a representative basis, the design of the Medical Device and its compliance with the Essential Requirements must be examined by a Notified Body. The Notified Body issues a certificate that indicates, by referring to one of the Annexes II to VI of the MDD, what has been verified.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO– the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive, country or by the Notified Body's number (indicated next to the CE marking) via the NANDO homepage.
Check Conformity
Subject to the class of the Medical Device, the manufacturer has different options as to how to assess the conformity of the Medical Device. The stringency of the conformity assessment procedures depends on the class of the Medical Device. For each class, the manufacturer has the choice between two or more conformity assessment procedures. Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II to VII of the MDD. In both cases, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues (a) certificate(s) that indicate(s), by referring to one of the Annexes, what has been verified.
Whether the involvement of a Notified Body has been necessary or not, the manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.
Technical Documentation
Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.
The manufacturer or the authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of at least 5 years, in the case of implantable devices at least 15 years, after the last product has been placed on the market.
Affix CE Marking
Once the necessary steps have been successfully completed, the CE marking must be affixed to the Medical Device. The CE marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:
The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.
When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.
If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.