Medical Device Directive 93/42/EEC

Conformity assessment of medical devices

Incentive

The conformity of medical devices must be assessed under EU Directive 93/42/EEC before they are placed on the market. One part of the conformity assessment can be the certification of the QM system according to ISO 9001 and/or ISO 13485 by a Conformity Assessment Body (CAB) or Notified Body (NB). A positive assessment leads to the authorisation to use the CE mark and to place medical devices on the market. The manufacturer must provide evidence of the conformity of the product with the essential requirements set out in the directives and in the harmonised standards.

Outcome

Admission to EU market and CE conformity / EU certificate / Safe products / Legal conformity and compliance with standards

Target groups

Manufacturer according to Directive 93/42/EEC.

Validity

3 years - there is an annual audit to ensure that standards are being maintained and a recertification audit after 3 years.

Recognition

SQS is registered as a Notified Body under number 1250.
The SQS certificates according to the Directive 93/42/EEC are internationally valid.
The SQS certificate ISO 13485 offers international validity and is recognised worldwide through the IQNet partnership.

Combinations

ISO 13485, ISO 9001, ISO 14001

Daniel Taddeo