Sarah talks about internal audits, the PRRC (person responsible for regulatory compliance), classification of IVDs, transition timelines and the requirements for May 26, 2022. The video highlights some important points that manufacturers need to consider:
- Internal audits are the best way to show your notified body that you’re ready for the IVDR.
- A well-established PRRC signals a commitment to patients, users, public health and your organization.
- Don’t be caught off guard by the extended transition timelines. On the May 26 DoA, you still need your PMS ready, your vigilance in place, and your economic operator identified and registered.