Read our White Paper “Own Brand Labeling (OBL) of Medical Devices in the European Union: the end of an era?” and immediately learn more about:
- the OBL (Own Brand Labeling) – OEM (Original Equipment Manufacturing) context under the current European legislative framework;
- the regulatory changes introduced by the European Regulations MDR (EU) 2017/745 and the new OBL responsibilities;
- how the relationship between OBL and OEM will evolve in light of the much more stringent requirements of MDR.
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Do you need support in drawing up or revising your OBL agreement / Quality Technical Agreement (QTA)? THEMA’s specialists are on your side. CONTACT US