European Directives

TÜV Product Service, a leader in the field of medical device conformity assessment, is the leading Notified Body for medical devices globally. In the European Union (EU), there are three harmonized directives that apply to medical products:

• Medical Devices Directive (MDD, Council Directive 93/42/EEC)
• Active Implantable Medical Devices Directive (AIMDD, Council Directive 90/385/EEC)
• In Vitro Diagnostic Directive (IVDD, Council Directive 98/79/EC)

As a Notified Body for the Medical Devices Directive, the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Directive, TÜV Product Service can assist you in meeting all these requirements and more.

Medical Devices Directive
On June 14, 1998, the European Union Medical Devices Directive (93/42/EEC) became mandatory for all manufacturers selling medical devices in the European marketplace. Today, all medical devices sold in the EU must have the CE Marking affixed to demonstrate compliance to this directive.

If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law. If you manufacture a Class I Sterile, Class I Measuring, IIa, IIb or Class III device, a Notified Body must be involved in the conformity assessment process to sell your product in the European Union. For Active Implantable Medical Devices, a Notified Body must be involved if your device falls within the scope of this Directive.

Based on the indications for use, all medical devices may be classified according to the rules of Annex IX of the Medical Devices Directive. Click here for a map of conformity paths for the Medical Devices Directive.

Additionally, in accordance with classification rules contained in Annex IX of the Medical Devices Directive “…medical devices manufactured utilizing nonviable animal tissues or derivatives rendered non-viable are Class III devices.” Therefore, such devices are required to utilize a Notified Body to obtain an EC design-examination certificate or EC type-examination certificate. These requirements are outlined in Directive 2003/32/EC which details specification with respect to medical devices manufactured utilizing tissues of animal origin.

Contained within the Annex to Directive 2003/32/EC is the requirement of the manufacturer to justify, based on their overall risk analysis and risk management strategy, the decision to use TSE-susceptible species animal tissue. This justification will be one of the main focuses of the Notified Body examination.

Product Assessment:
There are 14 requirements of Annex I of the Medical Devices Directive that are similar to the requirements of the Active Implantable Medical Devices Directive. TÜV is a leading testing laboratory and documenter of test results for your technical file development efforts, and as an Annex III Type Examination Notified Body. TÜV can fulfill your product testing needs at our state-of-the-art facilities located throughout the world, to harmonized European Norm (EN) standards, international standards (CISPR, IEC and ISO), European national standards (VDE, BS, etc.), and third-party standards (AAMI, ASTM, ANSI, etc.).

The CE Marking is a European Union requirement to sell medical devices that fall under the scope of the Medical Devices Directive and Active Implantable Medical Devices Directive. The CE Marking demonstrates that the manufacturer has declared that they meet the requirements of all applicable directives.

For information regarding the In Vitro Diagnostic Directive, click here.

For more information, contact us.