Medical Devices

Under the European Union’s guidelines, manufacturers of high-risk medical devices shall seek their certification by a Notified Organization.
This can be achieved through product testing and/or an audit to the manufacturer’s management system.
TÜV Rheinland is a Notified Organization for all kinds of medical devices. Products and management systems are certified in European Community’s countries, as well as in non-Community countries.
Only medical devices that have complied with all the requirements of the following directives can be commercialized in the European Union:

93/42/EEC for medical devices (MDD)
90/385/EEC for active implantable medical devices (AIMD)
98/79/EG for in-vitro diagnostic medical devices (IVDD)

TÜV Rheinland Product Safety GmbH, one of the few organizations notified for the certification of the above-mentioned directives, helps carrying out the conformity evaluation process for the EC market.

The steps are as follows:

1. Define the use of the device

As manufacturer, you should establish what will be the use of the device, thus defining the applicable directive (MDD, AIMD, or IVDD).

2. Classify the device

In the MDD directive, the medical device is classified pursuant to the rules of Annex IX. AIMD directive does not contain any classification. The IVDD directive distinguishes between self-diagnosis devices, devices for the verification of operation, devices included in lists A and B, and devices that are not included in any of the above-mentioned categories.

3. Determine the conformity evaluation process

Depending on the device classification, the Notified Organization is required, for instance, for the EC type examination, for the evaluation of technical documents or for the performance of management system audits. Devices included in the AIMD directive always require the participation of a Notified Organization.

4. Technical documents

The manufacturer must prepare the technical documents of each medical device: description of the device, design documents, applicable standards, and the description of the solutions adopted for the compliance with essential requirements, risk analysis, testing reports, clinical data, instructions for use, and additional information on the sterilization processes and validation certificates.

Through the conformity evaluation process, it is possible to evidence compliance with the essential requirements listed in Annex I of the corresponding directive. As a manufacturer, you can choose the most appropriate and convenient conformity evaluation method to evidence compliance with the essential requirements.

5. Conformity evaluation process implementation

Generally, the manufacturers of medical devices choose the quality management system audit. Auditors evaluate management system documents before the audit process begins and verify the implementation of the processes described during the company’s audit. The duration of the audit and the number of auditors depend on the size of the company and on the variety and type of products. After the audit process, the company receives a written report with the audit results.

As an alternative, you can choose the EC verification process (through individual sampling or sampling of devices) pursuant to Annex IV (MDD) or Annex VI (IVDD). If the conformity evaluation process was successful, the TÜV Rheinland Product Safety GmbH certification center shall issue a certificate of the devices for the EC market.

Web page of TÜV Rheinland Product Safety: click here

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