Regulatory Strategy

The European Regulation Concerning the Medical Devices

Introduction

European regulations concerning MDs are demanding, if you don’t have the experience or the proper human resources to know the right information and get the right advice at the right time you may spend more money than expected and make bad decisions.

BIORIUS & Your Medical Devices

BIORIUS can help you at different times, for example to:

  • Define your MD indications
  • Determine the MD classification
  • Determine the appropriate procedure to obtain your CE marking
  • Choose your Notified Body

The new regulations cause an increase in the number of MDs requiring the intervention of a Notified Body.

If you have never been through this type of assessment and if you don’t know the rules, you may fail or need much more time and money before you are allowed to put your device on market.

Important Points

  • Having a Technical File in accordance with the requirements of the new regulations is mandatory, even for class I MDs, do you have one for each one of your Medical Devices?
  • A number of MDs change their classification, usually for a higher risk class with more obligations, are you concerned?

Contact Us

Don’t hesitate to contact your dedicated account manager or your sales representative to have access to this service.

Otherwise, just click on the bottom.

Contact

Avenue Leonard de Vinci, 14
1300 Wavre, Belgium

+32 2 888 40 10
+44 20 3866 1208

info@biorius.com

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