Hi

Could you please tell me whether CEN standards are legally enforceable, or do they only operate as a guideline?

Thanks

Janine Carroll

Hello Janine

Standards in general are not legislation. They become legally binding only when a national government makes them so, or when they are cited in a contract. CEN standards were made to minimize the risk and optimize the security for user and the patient. Standards do set the quality level by using them as the yardstick to judge whether or not a product or procedures is up to level. Besides being an important guideline, Standards represent an important source of information as they are examined at least every 5 years to reflect the state of the art.

Best regards
Josy Holdener

Directive is a must. Eu states legalize a Directive. But a Directive instructs "What shall be done". You comply with a Directive by using a standard. It instructs "How to do".

Today, by legalization of Directives, the manufacturer's interest is compliance with applicable standards. The moment he affix the CE Mark and provides a "Declaration of Compliance" he has the comprehensive responsibility. He takes this risk by relying on Standards.

Compliance enssures (usually) safety and effectiveness.

The American Standards emphasis at the "Forward" that it is voluntary to use a Standard.

Who will buy a device that is not?

Dear,

Josy told you rightly that the European norms describe "the state of the art". But nevertheless they can have legal consequences. In case something goes wrong, due to the CSSD, and it appears that the department is working under and thus not conform the norms it can be held liable. Deviations from the standards have to be justified and documented.

Best regards,
Wim Renders

p.s.

• See also: www.cen.be/aboutcen/whatis/objectives.htm
• European directives are legally enforceable.