Implementing the EU Medical Devices Directive 93/42/EEC

Stage 4: Which 'Conformity routes' are available to you & which is your best commercial option?

All devices (other than those that are Class I [and are non-measuring or non-sterile], custom-made, or for clinical investigation) require intervention and audit by an appropriate Notified Body. An ISO 9000 type audit by a Registrar will not suffice.

Article 11 of the Directive details the available conformity assessment procedures. Specific details of these procedures are detailed in the Annexes of the Directive. The nature of the Quality System required becomes more in-depth as the classification of the devices increases.

The Directive offers the manufacturer various options to choose from. It is therefore essential that the manufacturer takes the opportunity to choose an option that not only meets the mandatory requirements, but is also beneficial from the manufacturing perspective. That is, a quality control and testing (Annex III) orientated option will potentially create delays for the manufacturer and generate ongoing unnecessary costs. It is a popular misconception that a manufacturer must have his devices tested by a Notified Body, this is definitely not the case. An appropriate quality assurance based option, as detailed in Annex II, affords the manufacturer greater freedom for product development and provides the opportunity for increased profit potential.

References 93/42/EEC
 · Article 11 - 'Conformity Assessment Procedures'
'Route Maps' are available from AMTAC to assist in the interpretation of Article 11
 · Annexes II,III,IV & VI - Conformity Schedules
See EN 46001 & EN 46002 to assist in the interpretation of Annex II & Annex V, respectively
You can, & usually should avoid Annex III 'Type Testing' by a Notified Body