Implementing the EU Medical Devices Directive 93/42/EEC

Stage 6: Implement your conformity route

In the majority of cases, a manufacturer is strongly recommended to use the appropriate Harmonised Standard to supplement/ interpret the requirements of the Directive with regard to their EC Declaration of Conformity/ Quality System.

Manufacturers are advised to implement Annexes II, V and VI (as appropriate) in conjunction with the harmonised standards in the EN ISO 9000 and the EN 46000 series. These standards give a practical, although not totally comprehensive, interpretation of the Conformity Annexes of the Directive.

Furthermore, this approach will permit manufacturers to also be registered against ISO 9000/EN 46000 as part of the audit process. Thus combining regulatory, management and marketing requirements as part of one integrated activity.

Be sure to project manage the implementation programme and incorporate the statutory compliance issues of the Directive with your company wide quality assurance system.

If you already have existing systems designed to meet other external requirements (e.g. FDA) then it is sometimes appropriate to cross-reference your compliance system for the Directive to these existing programmes, thus avoiding duplication, unnecessary expense and possible system conflicts.

References 93/42/EEC
Pre amble - Harmonised Standards
Annex II : Use harmonised standards EN ISO 9001 & EN 46001
Annex V : Use harmonised standards EN ISO 9002 & EN 46002
Article 5 - Reference to Standards
Annexes II, IV, V & VI - EC Declaration of Conformity