IVD (In Vitro Diagnostics) devices are regulated by EU Directive 98/79/EC of 27. October 1998. Examples of IVD devices include reactors, instruments, or other devices used for examining sample material from the human body, including blood and tissue samples, for the exclusive or primary purpose of providing information to ensure a correct patient diagnosis.
The CE-mark is a requirement for selling medical products and equipment in the EU. Additionally, an increasing number of other markets internationally require CE-marking.
IVD Directive compliance requires that a product is correctly classified. The IVD Directive defines products into List A or List B products, which determine the relevant conformity assessment procedure in Annex II. DGM is appointed notified body for IVD devices under the IVD Medical Devices Directive, and can assess and certify quality systems to allow CE marking of products according to the IVD Directive.
Presafe can help you with the complete approval process:
- Technical documentation/file or design dossier assessment/review
- Production quality assurance equivalent to ISO 13485
- Full quality assurance equivalent to ISO 13485
The IVD technical assessment/design dossier review is carried out by DGM, Presafe´s subsidiary in Denmark. Auditing of manufacturer's system is carried out at their premises. Presafe can also provide guidance, interpretation of directives relevant to specific products and training.