Eu Regulations on Medical Devices & Food supplements

The European Union established in 1985 the “New Approach to Technical Harmonization”, aiming to turn the standardization process more flexible and speedy. The European Council became more focused on the essential requirements that each product would have to satisfy – referred, in general, to safety, health, and environment’s and consumer’s protection – transferring the definition of technical details to private standardize organizations, as CEN – Standardization European Committee, CENELEC– Electrotechnical Standardization European Committee and ETSI – Telecommunications Standards European Institute. (INMETRO, 1997)

At the same time, was established the concept of “Global Approach to Conformity Assessment”, through which was consolidate the “mutual recognition” principle for foreign technical standards and regulations. According to this principle, any product legally commercialized in a European Union country must be accepted in the others, since it meets the essential requirements, or it is in accordance with the standards considered “equivalents” by the European Council.

In “New Approach” are developed three directives related to medical devices:

• Directive on Active Implantable Medical Devices - 90/385/EEC;

• Directive on Medical Devices - 93/42/EEC.

• Directive on In-vitro Diagnostics Medical Devices - 98/79/EEC.

  In this article it is considered only the second Directive, since the others show particularities that are out of this scope.

  According to EUROPEAN COMMUNITY COMISSION (2003), Directive on Medical Devices – 93/42/EEC encloses the medical devices that are not specified in the two other directives. It divides the products in four risk classes:

  Class I: low potential risk (example: correction glass lenses);Class II A: medium potential risk (example: filling material for teeth); Class II B: high potential risk (example: X-ray equipment);

  Class III: critic potential risk (example: cardiac valves).

  The Directive on Medical Devices – 93/42/EEC was established on January 1st 1995. Since June 14th 1998, when the implantation period was finished, all medical devices in European Union should be conform to the established requirements and showing the CE mark (CE - Conformité Européene), which means that a producer, or its legal representative, declares that the product is in accordance with every applied standards and it has been submitted to adequate conformity assessment arrangements.

  The harmonized technical standards are related on European Community Official Journal, according to Article 5 of Directive 93/42 EEC

IDIRECTIVE 2002/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 10 June 2002
on the approximation of the laws of the Member States relating to food supplements
(Text with EEA relevance))