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European Medical Device Directive
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 the applicable European medical device directive and more.
NBOG (Notified body Operation Group)
On March 21, 2010, the EC Directive 2007/47/EC became effective and has a big impact on the Directives 90/385/EEC and 93/42/EEC. All manufacturers declaring conformity of their products to either of these EC Directives should be aware of the following: Medical devices according to 90/385/EEC or 93/42/EEC must also comply with the new EC Directive starting March 21, 2010, otherwise the products cannot be placed on the European market.
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.
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 nonviable 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.
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.