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