Medical Devices Directive 93/42/EEC

Before you can market your medical device in the EU, your product must meet the essential requirements in Annex 1 of the Medical Devices Directive (MDD), as well as the standards related to your device type.

Reference the classification rules in Annex IX of the MDD to determine your device class: 

  • Class I devices with low risk such as external patient support products
  • Class IIa/b devices with medium risk such as electro-medical devices
  • Class III devices with high risk such as cardiovascular catheters
You can read more about Medical Devices on the EU Commission’s website.

At this moment in time we do not take on any MDD clients. For more information, please contact the Notified Body at medtechsweden@intertek.com.

Intertek Medical Notified Body is part of the Code of Conduct for Notified Bodies in Europe and our scope of designation can be viewed on the Nando website.

The Medical Device Regulation (2017/745)
The Medical Device Regulation (MDR) (2017/745) will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on Active Implantable Medical Devices (90/385/EEC).

We applied for MDR early 2018 to our Swedish Medical Products Agency (MPA). We anticipate to be designated in the first half of 2019. More information will be available at that time on our website, including the application process, our MDR pricelist, and public declaration of interest of our Notified Body’s top level management.

Intertek Medical Notified body does not provide consulting services. Any consulting activities provided by Intertek Group are separate and independent from certification activities of the Notified Body.
 

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Regulatory Requirements for Medical Equipment