DNV is delighted to announce their Notified Body 2460 in Oslo successfully achieved designation by the Norwegian Health Authorities and the European Commission as a Notified Body for Medical Devices Regulation (EU) 2017/745 (MDR). The designation was successfully granted for all technology types applied for, including the highest risk Class III devices, ensuring continuity of European market access for our customers’ lifesaving medical technology.
Who should attend?
All Medical Device Manufacturer of Class IIa, Class IIb and Class III
Course Highlights:
- Requirements of Clinical Evaluation under MDR 2017/745
- MDCG Guidelines on clinical evaluation
- CER Requirements for Class IIa, Class IIB and Class III manufacturer for clinical evaluation
- Legacy Devices CER applicability
- Clinical Investigation
- Requirements of PMS and PMCF for all class of devices
- General Safety and Performance Requirements and CER
- Basic Technical Documentation preparation for MDR
