Implementing the EU Medical Devices Directive 93/42/EEC

Stage 5: Choose your Notified Body

It is important to start forming a relationship with your Notified Body as early as possible in the process of implementing the Directive in your business. You will no doubt have many questions. Your chosen Notified Body should be able to assist your interpretation of the Directive in a practical way that suits your business. Choose a Notified Body that sees their role as a partnership arrangement with your organisation. Select an organisation that you would want to deal with as a supplier of services - because indeed, this is what they are.

Not all Notified Bodies are the same. Check to see that your proposed Notified Body is approved to authorise the 'CE' Marking on the type of devices that you both manufacture currently and may plan to manufacture in the future. Furthermore, the Notified Body must be authorised to assess the conformity route that your company has chosen to follow.

You may employ the services of any appropriately qualified Notified Body, independent of which Member State they are from and in which Member State you are manufacturing or supplying devices to. Consider the specialism of the Notified Body and their experience with the Directive itself. You do not wish to be part of their learning curve. Also consider whether you would wish to deal with them and their Competent Authority (Government) in the case of difficulties. Whilst their assessors may speak your language locally, are you able to speak the language of their Member State if legal action is required for any reason.

WE HOPE YOU DECIDE TO USE AMTAC !!

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References 93/42/EEC
· Article 16 - 'Notified Bodies'
AMTAC operate globally & are authorised for all medical devices.
We provide ISO 9000 / EN 46000 Registration as part of our audit for Annexes II & V
· Article 20 - Confidentiality