CE Approval Guide for Manufacturers <10>
Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.
If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:
- Identify the applicable directive(s) and harmonised standards
- Verify product specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).
These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.
For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.
Product groups
In vitro diagnostic medical devices
Legislation
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 mentioned in Article 1 are applicable. If all these conditions are fulfilled, Directive 98/79/EC applies.
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- Directive 98/79/EC on in vitro diagnostic medical devices
- For further information on in vitro diagnostic medical devices, please visit the webpage on medical devices
- More on harmonised standards for in vitro diagnostic medical devices
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.
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