Thursday was filled with many of the same messages that we have been hearing from our membership: the date of application of IVDR may have come and gone, but the work does not stop in becoming IVDR compliant, and there remains a shortage of IVDR Notified Bodies. This is a consensus shared across the sector, including from industry, the European Commission, and the Notified Bodies themselves.
Highlights of the Summit included confirmation that a further 3 Notified Bodies are expected to be designated by the end of the year, hearing the IVDR point of view from industry and the difficulties faced, and a session on the comparisons globally of companion diagnostics.
Ashleigh, BIVDA’s Regulatory Affairs Manager, spoke on both days. Thursday’s talk discussed how Trade Associations can help industry navigate the regulatory world, including case studies on how BIVDA has helped make a difference to industry. Friday’s talk covered the post-market surveillance requirements under the IVDR and some insights learned so far.
It has been fantastic to see people again in person, including a number of BIVDA members who came over to say hello!