EC Directive 93/42 relative to medical
devices came into force on 1st January 1995 and became
mandatory on 16th June 1998. Only those devices having the
following characteristics can be marketed:
they satisfy
the essential requirements of the Directive;
the products
and/or the company has been approved by a notified body (with
the exception of Class I products);
they bear the CE
marking followed by identification number of the notified body
(with the exception of Class I products).
The Directive divides the products into four
classes, depending on the hazard level of the device. The
classification parameters are given in Annex IX to the
Directive. For each class, the Directive dETLribes the
possible procedures for the attestation of conformity to the
essential requirements. In particular:
for Class I
products, the manufacturer can affix the CE marking after
having made a Declaration of Conformity to the essential
requirements;
for Classes IIa, IIb and III, the
intervention of a notified body is required.
The manufacturer can choose among product
certification (type certification + lot tests), full company
quality system certification, or a mixed system (type +
production or product quality system certification).
