On March 21, 2017, the International Dental Show (IDS) in Cologne will open its doors to over 140,000 professionals from the dental industry. In the run-up to the event, we thought we’d tell you a few things about registering dental devices in Germany.
Dental devices must be registered with DIMDI (German Institute of Medical Dokumentation and Information). CE approval for class II and III devices is granted by the notified body, while authorized representatives are responsible for self-declaring that class I (non-measuring, non-sterile) devices conform with regulations.
Dental Devices are divided according to risk level.
QUALITY MANAGEMENT SYSTEM
An ISO 13485 quality management system (QMS) must be in place for class II and III devices. These are audited by notified bodies.
A new clinical evaluation guidance (MEDDEV 2.7/1 revision 4) came into force in June 2016. Implants and high-risk devices that are based on technologies where there is little or no experience and those that extend the intended purpose of an existing technology (i.e. a new clinical use) are most likely to require clinical investigation data. Usually, a strong clinical evaluation report (CER) will be accepted without the need for trials.
The registration process for Class I devices takes 2-4 weeks. For the other classes, it depends on the contract with the notified body, the type of device and the status of current documentation.
Licenses for class I devices do not expire, whereas licenses for class II and III devices are valid for a five-year period.
You can register products quickly and cost-effectively in Germany and 100+ other countries through our regulatory intelligence and registration management system, LICENSALE.COM®. Furthermore, we offer an authorized representative service in Germany and other EU countries. If you’d like to discuss how we could transform your regulatory pathway, please contact us today.