Key changes of the IVDD IVDR
Re-classification of devices – risk classes will range from Class A for low-risk devices to Class D for those devices that pose the greatest risk to patients and the public.
Increased Notified Body Involvement - the application of the IVDRs risk classification scheme requires the involvement of a Notified Body for the approval of all but Class A non-sterile devices.
Implementation of unique device identification - the regulation mandates the use of unique device identification (UDI) mechanisms.
More stringent requirements regarding technical documentation and clinical evidence - the level of detail regarding the contents of the technical documentation is increasing substantially. There are prescriptive requirements requiring additional reports to be prepared.
Greater Scrutiny of Notified Bodies – Competent Authorities and Reference Laboratories have to be involved in the conformity assessment of high-risk devices such as CDx and Class D.
No "grandfathering" provisions – under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.
Identification of 'a person responsible for regulatory compliance' (PRRC) - device manufacturers are required to identify at least one person within their organization who is responsible for oversight of aspects of compliance such as keeping technical files up to date, PMS, and clinical performance studies. Authorized Representatives also require a PRRC.