Medical Devices Directive 93-42-EEC

Comply with the Requirements of the MDD

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. With the support of our experienced team of testing experts, your path to compliance is clear; we offer guidance for creating your Technical File, documenting risk, establishing conformity to ISO 13485, and testing and certification to harmonized standards so that you can apply the CE Mark and get to market faster.

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

All Class Is, Im, IIa, IIb, and Class III devices require Notified Body approval – learn how we can help.

We provide guidance related to regulatory issues for accessing international markets – learn more.

Intertek is a signatory of the Code of Conduct for Notified Bodies

 

 

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.

 

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Regulatory Requirements for Medical Equipment