Biomedical engineering enables today’s remarkable developments in medical knowledge to be applied in practice. DNV is involved in the CE marking of medical equipment – a matter of life or death.
DNV’s notification covers approximately 6000 products. 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.
DNV has been appointed the notified body for all medical devices under the Medical Devices Directive, annexes II and V.
Our services include:
- Technical documentation/file or design dossier assessment/review
- Production quality assurance (based in ISO 13485)
- Full quality assurance (ISO13485)
The Medical Devices Directive was adopted on 14 June 1993, as part of the process of removing barriers to free movement as well as of securing the safety aspects of medical devices within the EU/EFTA member states.
In total, DNV has issued approximately 1100 certificates. Today DNV is involved in the CE assessment of medical devices in Europe, America, Australia, and Asia.
Why DNV can help you
It is important that people who come into contact with medical equipment know what CE marking involves, and that they can trust the label.
Without CE marking, a product is worthless. Once it is CE labelled, the product can carry out its function and both save and prolong life.
DNV has highly qualified personnel who carry out the CE assessments at customers’ premises. We have 25 offices around the world who are involved in CE marking of medical equipment.
DNV is member of the European Association of Notified Bodies for Medical Devices.
Read on about how to comply with the directive.