Directives 90/385/ECC, on Active Implantable Medical Devices (AIMDD), 93/42/EEC on Medical Devices (MDD) and 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD)

• define the essential requirements that devices must meet before being placed on the market
• establish conformity assessment procedures and create mechanisms available to national competent authorities to manage implementation or to intervene on the market when reasons of public health so require
• contain provisions on conformity assessment procedures
• deal with the free movement of medical devices
  

“These three directives are being revised (September 2006) with the aim to further support the protection of human health” (sic, the European Parliament ENVI committee).

The proposed 93/42/EEC directive has re-kindled the controversy surrounding the processing of so-called ”single use” medical devices. The controversy revolves around two main issues:

• Should the reprocessing of so-called “single use” medical devices be made subject to more detailed regulation at the EU level?
• Should the reprocessing of so-called “single use” medical devices be prohibited at the EU level?
  

The medical device reprocessing industry calls for more detailed regulation of medical device reprocessing in the amendment of Directive 93/42/EEC, while the medical device manufacturers demand a general prohibition on the reprocessing of medical devices.

Neither the EU Directive nor national norms make a distinction between single use and multiple use medical devices. The decision to declare a medical device as single use or multiple use is made by the manufacturer alone. However, the declaration that a medical device is “single use“ does not mean that reprocessing and re-use is prohibited. With this term, the manufacturer is merely declaring that the possibility of reprocessing has not been tested and that manufacturers’ liability for a product applies only to its first use.

Next steps:

• 04/10/2006    EP: report scheduled for adoption in committee, 1st or single reading
• 14/11/2006     EP: probable part-session scheduled by the DG of the Presidency, 1st reading
• 30/11/2006     Council: political agreement on common position expected