1. Distributor meeting
Regulatory aspects

3. Topics Customs  Regulatory RUO  IVD: limitations
RUO  IVD: possibilities
Registration IVDs
CE  IVD
Marketing and regulation
Status in your territory

4. 1 Customs  Regulatory Different acceptance criteria
Customs: monetary value and safety of handlers (animal, infectious or toxic materials contents ).
Regulatory: safety of patient (product-application).
Different documentation required
Customs: declaration on composition and value.
Regulatory: full registration file.

5. 2 RUO  IVD: limitations RUO not intended for diagnostic use.
GenDx can not and does not support the use of RUO products for IVD purposes.
Countries with IVD-regulatory requirements: Distribution non-registered IVDs = illegal and subject to sanctions.

6. 3 RUO  IVD: possibilities
GenDx RUOs and IVDs are IDENTICAL:
Same production procedure
Same quality and acceptance criteria
Same quality control procedures
Same performance
Only difference: box label.
Declaration of equivalence can be made available.

7. 4 Registration IVDs
Purpose: permission from national competent authorities to distribute IVDs in its territory.
Procedure: supply information on intended use, design of device and technical evidence of safety.
Method: submit registration file based on international format (GHTF) setup + additional territorial requirements.
YOU CAN ASSIST IN THIS!

8. 5 CE  IVD CE= Conformité Européene
Valid only in: EU-/EER-member states, Norway, Switzerland and Turkey
Outside of CE-territories CE has not IVD validity
New IVD-registration is necessary

9. 6 Marketing and regulation
Marketing unregisterd products as IVD is illegal
Check your territory’s rules for marketing IVD devices / RUO products

10. 7 Status in your territory