Legislation

As a first step, you need to verify whether your product(s) fall(s) within the definition of an active implantable medical device in accordance with Article 1 paragraph 2a) to c) of Directive 90/385/EEC where the term 'active medical device' is also defined. For a definition of 'implantable device' see Annex IX, section I.1.2 of Directive 93/42/EEC on medical devices. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 6 is applicable. If all these conditions are fulfilled, Directive 90/385/EEC applies.

• Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive 90/385/EEC on active implantable medical devices
• For further information on Directive 93/42/EEC on Medical devices (MDD), please visit the webpage on the medical devices sector

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) can apply.

Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) specifies general requirements 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 1 to the AIMDD. Compliance with the essential requirements must be demonstrated by a clinical evaluation in accordance with Annex 7 to Directive 90/385/EEC.

Need for notified body?

For all active implantable medical devices, the involvement of a Notified Body is obligatory.

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

A Notified Body verifies, in most cases, both the quality management of the manufacturer and the design of the medical device and its compliance with the Essential Requirements. The manufacturer may also choose another conformity assessment route. In that route, the Notified Body verifies the product type for the conformity with the Essential Requirements and the conformity of the final products with the type. 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 2 to 4 of the AIMDD, what has been verified.

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 his authorised representative established in the European Community is required to keep copies of the technical documentation for a period of 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 must 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 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.