International Standards and Conformity Assessment for all electrical, electronic and related technologies

CEN/CLC/TC 3

Quality management and corresponding general aspects for medical devices

 
 
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CEN/CLC/TC 3 Scope

CEN/CLC/TC 3

The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62.

The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards;

- to minimize the necessity for additional European requirements;

- to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.

Further information

Secretariat
Netherlands
CCMC Programme Manager
DELLA FAILLE DE LEVERGHEM Alexandre