Key changes of the IVDD IVDR
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 and Competent Authority 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. High-risk devices such as Class D or CDx require the involvement of Reference Laboratories or Competent Authorities such as EMA.
Technical documentation and clinical evidence - Requirements are more stringent, technical documentation and clinical evidence are more prescriptive and more detailed.
Implementation of unique device identification - the regulation mandates the use of unique device identification (UDI) mechanisms. These barcodes help to improve traceability throughout the supply chain.
No "grandfathering" provisions – under the IVDR, all CE-marked in vitro diagnostic devices must be assessed in accordance with the new requirements. Notified Bodies will expect that current guidance and standards have been considered and gaps assessed and closed.
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. The PRRC must meet specific qualification criteria.