posted 07 October 1998 02:59 AM               

The Medical Device Directive's Seven Major Myths

Mystified by the European Union's Medical Device Directive? The following seven points touch on some of the directive's persistent myths and how it will affect manufacturers:

Myth No. 1: CE marking is a trade barrier. Fact: The European Union views the CE Mark much like a passport. It is a manufacturer's claim that its product meets all applicable directives in force at that time. Member states must allow CE-marked products free market access.

Myth No. 2: The June 14, 1998, deadline was extended. Fact: There was no extension, and the current deadline was enforced.

Myth No. 3: All products placed on the market prior to the June 14, 1998, deadline will be exempt from CE marking until 2001. Fact: This is still only a proposal. Even if it is accepted, companies are finding sales negatively affected by the CE Mark's absence.

Myth No. 4: Countries in the EU can impose additional requirements within the directive. Fact: Countries must give products legally displaying the CE Mark free access to their markets. Member states may only restrict products that endanger the public.

Myth No. 5: ISO 9000 is sufficient to meet the directive's Annex II. Fact: In essence, EN 46001 is ISO 9001 plus specific medical requirements. Those additional quality items are found in EN 46001 and Annex II.

Myth No. 6: A manufacturer needs only a Declaration of Conformity for Class I Devices. Fact: Items required by the MDD's Annex VII include the technical file, post-market vigilance, risk analysis, and essential requirements for health and safety.

Myth No. 7: All 15 recognized European languages must appear on a product's label to meet EU standards. Fact: It depends on what the product is and where it is sold. Some member countries require their languages on the labels of any products marketed within their borders. The audience the product is meant for also must be considered.

For more information, call the MDD Hot Line at telephone (800) 810-9000.

posted 13 October 1998 08:26 PM               

To obtain a CE Mark for a medical device, your firm must be audited by a notified body. This is not true. That varies with the device and class.