How To Transfer Surveillance Oversight For IVDs From One EU Notified Body To Another

With the final deadlines for legacy products that need to comply with the IVD Regulation on the horizon next year, help is at hand to transfer responsibility for surveillance from one notified body to another. But who will need it and why?

Man passing the baton to partner on track against close up of the track starting point - Image — At Some Point, Surveillance Responsibility For IVDs Must Change Hands

Members of the TEAM-NB association of notified bodies have adopted an agreement specifying the terms of the transfer of the appropriate surveillance activities for legacy IVDs from one notified body to another.

Legacy IVDs are products that remain covered by an IVD Directive notified body certificate during the extended transitional periods they...