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The Medical Device Directive (MDD 93/42/EEC)

The Medical Device Directive 93/42/EEC (MDD) was established on June 14, 1993 and entered into force on July 12, 1993. The MDD 93/42/EEC relates to medical devices and their accessories. The Directive replaces Directive 76/764/EEC and was amended by Directive 98/79/EC, Directive 2000/70/EC, Directive 2001/104/EC, Regulation (EC) No 1882/2003 and Directive 2007/47/EC.

The MDD Directive is the most important provision instrument concerning the safety of medical devices in the European Union. Among other things, the main intention of the MDD 93/42/EEC is to ensure the free movement of goods within the European community and to make sure that the devices are not dangerous for the user’s health. The MDD 93/42/EEC outlines and establishes requirements for the design as well as packaging of medical devices.

The Annex I of the MDD 93/42/EEC sets out the ‘essential requirements’ regarding safety, operation and labeling of the medical device. According to the MDD 93/42/EEC, Article 1, a “medical device” is any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended to be used by human beings regarding mainly the following purposes:

  • Diagnosis, monitoring, treatment of disease
  • Diagnosis, monitoring, treatment of or compensation for an injury or handicap
  • Investigation, replacement or modification of the anatomy
Among others the following goods are seen as a medical device under the MDD 93/42/EEC:
  • ECG
  • Dental materials
  • Hip prostheses
  • Heart valves
  • X-ray equipment
Regarding Article 1 of the MDD 93/42/EEC it is not applicable to the following:
  • Active implantable devices
  • In vitro diagnostic devices
  • Cosmetic products
  • Personal protective equipment
Concerning Annex IX of the MDD 93/42/EEC medical devices have to be classified. The classification procedures are set up in Annex II – VI of the MDD 93/42/EEC. To comply with the MDD 93/42/EEC it is also obligatory to notify the product with the competent authority of the Member State. Furthermore, for a device or product falling under the MDD the CE-Marking (Directive 93/68/EEC) is applicable.

An essential element of compliance with the MDD 93/42/EEC for non-European Manufacturers is selection of a European Authorized Representative. A European Authorized Representative acts as a legal identity of a producer based outside of Europe and offers different Authorized Representative Services that aid in this process . Once a European Authorized Representative has conducted the necessary notification and registration and the CE-Marked product is properly put on the EU market, it is able to circulate freely within the EU and the European Authorized Representative monitors the compliance of the Non-EU producer with the relevant Directives and Regulations.

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.

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