The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies (NB) and IVD legal manufacturers are getting ready for this huge change. From the 40 pages directive to a 157 pages Regulation, from 80% of IVD being self-certified without the involvement of an NB to 90% of IVD being CE mark with the NB scrutiny, we will look at the main changes in the way of working to place an IVD on the market. Several subjects from post-market surveillance, clinical performance to QMS will become much more prominent and will require a higher level of documentation and evidence.
Today 14th October 2021 the European Commission has issued a Question and Answers press release on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation:
https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210
“Progressive roll-out” is in effect a postponement of compliance to the IVD Regulation for most categories of devices. Reasons for the proposed longer transition periods are cited as; minimal designated Notified Bodies, lack of capacity within Notified Bodies and continuing effects of the pandemic.
What does this mean to manufacturers?
This session will allow you to ask our experts questions about the upcoming changes and the implications for SMEs and larger companies. VCLS is involved with NB interactions on a regular basis and helps the client to support this transition in a most smoother way.
Some questions we will answer during the session:
- Is the ISO 13485 certification enough to reach IVDR requirements?
- What is the role of the PRRC?
- Which areas are affected most by the new regulations?
