Brief Analysis Of The Proposed Changes To The Medical Device Directive 93/42/EEC

I. Medical Devices In Europe.

The EU Commission well understands the strategic importance of the medical device sector for Europe. Europe is the second-largest world market for medical devices, and about 8,000 types of devices are on the Community market. Additionally, the medical device sector, a highly innovative industry, is recognized as having a crucial impact on the quality of life of European patients, and impacts health care and health policy.

II. Legal Framework.

The basic legal framework on medical devices was laid out at the Community level during the 1990s. Three main directives have been enacted, in the following three fields:

Directive 90/385/EEC on active implantable medical devices;

Directive 93/42/EEC on medical devices ("MDD"); and

Directive 98/79/EC on in-vitro diagnostic.

Other Directives in this area include Directive 2000/70/EC, on medical devices incorporating stable derivates of human blood or human plasma, and Directive 2003/32/EC, on medical devices manufactured utilizing tissues of animal origin.

This article focuses on the MDD and on the changes that the Commission is considering adopting to improve the regulation of the medical device sector.

III. The Medical Device Directive.

The MDD is based on the principles of the so-called "New Approach" to technical harmonization and standards. In accordance with the New Approach, the MDD does not analytically specify the technical features that medical devices must possess, but instead defines the essential requirements that devices must meet in order to be marketed. This approach appeared more appropriate for the regulation of rapidly evolving technologies, whereas a detailed specification of the devices' features would have necessitated a constant update of the applicable provisions to describe the ever-changing state of the art.

Under the MDD, devices are subdivided into four categories, depending on the potential risks that are associated with their use. Assessment procedures for Class I devices are based on the manufacturer's evaluation only, while Class IIa, IIb and III devices may be marketed only after a specific, so-called "Notified Body" has inspected them.

IV. CE Marking.

Manufacturers of medical devices must perform a risk/benefit analysis regarding any device, reduce risks to the minimum, adopt any adequate safety measure, and fully inform users of any remaining risk. Compliance with this required conformity assessment results in the issue of the...