Key changes IVDD IVDR gap analysis

Qserve is your EU-IVDR Remediation Expert and navigates you to the conformity routes.

Key changes IVDD IVDR

Although the scope of the IVDR regulation has not expanded significantly. There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more resources to maintain as well as implement. 

Qserve’s practical approach and established history in the sector allows us to bring our top consultants' interpretations to you. We can help you navigate through the new IVDR requirements, classification rules, and conformity routes by starting a GAP analysis.



Initial estimates predicted that under the IVDD
only 20% of manufacturers need a Notified Body
and under the IVDR >80% will require a Notified Body. 

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.

Services we offer for IVDD IVDR transition and implementation

Qserve regulatory IVD services for IVDR remediation

Let Qserve help you navigate through the new IVDR requirements, classifications, and conformity routes by starting a GAP analysis. 
  • GAP assessment
  • Training (virtual and/or on-site)
  • IVDR technical file creation support, including coaching your team through submissions
  • Presubmission file review
  • Experimental design to generate data to remediate technical files
  • Statistical support
  • QMS support
  • Post-market surveillance and post-market performance follow-up

Other IVDR services:

Services

 

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