TRAINING
IVDR How to work with a Notified Body?
There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more recourses to maintain as well as implement.
Where the IVD Directive 98/79/EC specifies Notified Body involvement for only a few high-risk IVDs listed in Annex VII, the IVD Regulation introduces
risk-based classification Class A to D. The outcome is that the conformity assessment process for CE marking for the majority of IVDs will now necessitate the involvement of a Notified Body, as opposed to self-declaration by the manufacturer under the IVDD.
The majority of IVDs currently self-certified will now require the services of a Notified Body in the conformity assessment process to ensure the intended purpose of the devices and their inherent risks.
Program overview
Duration: 2 hours (virtual or customized in-house, to be determined in consultation)
- Background to the IVDR
- The impact for manufacturers of the implementation
- Definitions, placing on the market, in-house exemption (LDT), distance sales and how these impact your IVDR submissions
- Classification and conformity routes
- The Notified Body Process
- How to select a Notified Body (NoBo)
- How to work with NoBo's effectively
Costs
- Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.