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Proven steps on the way to CE Marking
EC Directives:
- 93/42/EEC on Medical Devices (MDD)
- 90/385/EEC on active implantable medical devices (AIMD)
- 98/79/EG on in-vitro diagnostic medical devices
As a manufacturer, you may only present medical devices in the European market if all the requirements of the relevant Directive have been complied with. We help you carry out your conformity assessment procedure for CE marking as well as assist you to achieve worldwide approval of your medical devices. The individual steps towards CE marking for medical devices includes as below:
1. Definition of the medical device/intended use
As a manufacturer, you determine the intended use of your device. This results in a decision as to which directive is applicable to your medical device (MDD, AIMD or IVDD).
2. Classification of the medical device
In the MDD, the medical device is classified in accordance with the regulations in Annex IX. The AIMD does not provide for any classification. The IVDD distinguishes between products for self-testing, for performance evaluation, Lists A & B and products which do not fall into any of the categories named.
3. Determining the suitable procedure for conformity assessment
Depending on the classification of the product, a Notified Body is required for carrying out an EC type-examination, assessing a design dossier and/or auditing your QM system. AIMD products always require the involvement of a Notified Body.
4. Technical documentation
The manufacturer must prepare a technical documentation for every type of medical device which essentially consists of the following documentation on the product:
- Description of the device, design documents, the standards to be applied
- Description of the solutions chosen to meet the essential requirements, risk analysis, test reports, clinical data, labelling and instructions for use
- Additionally for sterile devices descriptions of the sterilization procedures used and the validation certificates.
Medical devices must meet the applicable essential requirements listed in Annex I of the respective directive. With the help of the conformity assessment procedure, proof must be provided that the safety requirements have been met and the technical services have been rendered. The medical effectiveness must be proven through a clinical assessment. The manufacturer is free to choose how he will proof the completness of essential requirements.
As a testing body for medical devices, we carry out various tests for you including safety, functional and biocompatibility tests. We perform them either in our own laboratories or in contracted laboratories. You can use the resulting test reports as an acknowledged proof for your technical documentation.
5. EC type examination or examination of the design of the product
For all AIMD, MDD Class III and IVDD List A products, the manufacturer must decide between the EC type examination procedure and the examination of the product design documentation. In this process, as your Notified Body, we either test the product including the product documentation or the design documentation. After successful examination, our certification body issues an approval in accordance with the directive.
6. Implementing the conformity assessment procedure
Usually, the manufacturers of medical devices choose the procedure of auditing their quality management system. The auditors assess the documentation of the QM system prior to the audit and verify the application of the written procedures during the audit at the company. Depending on the size of your company and kinds of products, the duration of the audit and the number of auditors are specified in an individual quotation. After the audit, you will receive a written report with the audit results.
As an alternative to the audit, the EC verification procedure (sampling or individual testing) in accordance with Annex IV (MDD) or Annex VI (IVDD) can be applied. If the conformity assessment procedure has been completed successfully, our certification body will issue an approval for the CE marking of your devices.