The Medical Device Directive (93/42/EEC)
The Medical Device Directive 93/42/EEC (MDD) is a directive designed to ensure that medical devices are safe and reliable within the European Economic Area. The Directive was most recently amended by the 2007/47/EC. Compliance with the new regulations will be mandatory beginning March 21, 2010.
An important aspect of the road to compliance is the correct classification of medical devices. The MDD 93/42/EEC is divided into different classes with varying requirements. These classes are determined by risk. The classification procedures are proposed in Annex II – VI of the MDD 93/42/EEC. Following these procedures will help manufacturers to determine the class of their devices but can be time consuming or confusing. Classification services provided by Obelis s.a. can help simplify the classification process.
Compliance for Class I Medical Devices for MDD 93/42/EEC:
When a device has been classified as Class I it is defined as a low risk device and non-invasive. Within Class I there are three different sub-classifications:
- Class I Non-Sterile
- Class I Sterile
- Class I Devices with a measuring function
These are important distinctions to make that could significantly alter the process of compliance
. Once all classification
has been made there are a number of steps that must be taken:
- A manufacturer must create a Technical File outlining specific aspects of the manufacturing process that can be submitted when requested by a European Competent Authority.
- Appoint a European Authorized Representative which will act as a legal representative in Europe. The European Authorized Representative fulfills many essential roles and duties and selecting the proper representative is very important.
- All devices must be notified to the proper authorities in each Member State of the EU.
- A Declaration of Conformity must be issued by the manufacturer.
Devices must be notified
with the competent authority of Member State where the appointed Authorized Representative
is located. For devices that fall under the Medical Device Directive
that are classified as Class I devices, the CE Marking
(Directive 93/68/EEC) is required as specified. Manufacturers outside the European Union must also appoint a European Authorized Representative
in order for the CE Marking
to be valid. A CE Mark has NO VALUE without a valid agreement with a European Authorized Representative
. A professional Authorized Representative
will assist Non-European Manufacturers with device classification
and regulation compliance
. Once a device bears the properly affixed CE Marking
and has met all compliance requirements, it can be placed in the EU and allowed free movement between all member states.
Note: Non-European Manufacturers are advised to appoint a European Authorized Representative in order to ensure compliance with EU Directives at all times.
CONTACT US to learn more about how a European Authorized Representative can assist you to comply with EU regulation.