The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive. In order to be compliant with MDD, you need to classify your products correctly. The MDD divides products into different classes, based on risk and intended use, which again determines the relevant conformity assessment procedure. For products classified with medium to high degree of risk, the MDD requires a conformity assessment procedure involving a notified body, such as DNV GL - Business Assurance.
How can we help?
We haves been appointed as notified body for all medical devices under the quality modules of the Medical Devices Directive, annexes II, V and VI. We are able to assess and certify your quality system so that you can affix the CE mark to your products according to MDD. The CE mark is a requirement to be able to sell medical products and equipment in the EU. Additionally, an increasing number of other markets require CE marking. Our services include:
- Technical documentation/file or design dossier assessment/review
- Production quality assurance equivalent to ISO 13485
- Full quality assurance equivalent to ISO 13485
We carry out the CE assessments at customers’ premises. We can also provide guidance and interpretation of the directive related to your products in particular, and provide training for better understanding of the directive. We are a member of the European Association of Notified Bodies for Medical Devices and have offices around the world who are involved in CE marking of medical equipment.