EU Medical Devices Directive 93/42/EEC

The EU Medical Devices Directive has had a dramatic effect on all suppliers of Medical Devices to the European Union - providing them with a single, unified approach to regulatory compliance. Failure to comply with this Directive (the transition period ended in June 1998) renders Medical Devices ILLEGAL FOR SALE IN THE EUROPEAN UNION (EU). Where applicable, an EU Notified Body must audit a manufacturer's quality system - this applies for manufacturing sites both within and beyond the borders of the European Union.

The European Commission has authorised a number of 'Notified Bodies' whose role is to act as 'Registrars' and facilitate the approval of the mandatory 'CE' Marking on Devices.

AMTAC were the first organisation, in the UK, to be appointed as a Notified Body for this Directive and were awarded the sole contract by the European Commission to provide assessor training for all of Europe's other Notified Bodies.

Overview of 93/42/EEC
We have compiled an overview of the Directive to help manufacturers gain an initial grasp of its general requirements and to suggest a practical approach to its implementation.

See an abbreviated version here

If you would like us to mail you a complete copy, free of charge, simply E- Mail your request to Alan Kirwilliam, akirwilliam@amtac.co.uk or fax or mail us.