Key changes IVDD IVDR gap analysis

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

Key changes IVDD IVDR

The scope of devices covered by the IVDR regulation has not expanded significantly compared to the IVDD, however, the amount of work required to transition from the IVDD to 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 will help improve the success rate of your submissions. 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

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.

Services Qserve offers for IVDD IVDR transition and implementation

Qserve regulatory IVD services for IVDR remediation

  • Let Qserve help you navigate through the new IVDR requirements
  • Perform a gap assessment of the regulation of standards
  • Review classification and conformity routes
  • Conduct training for the IVDR or detailed training on specific elements (virtual and/or on-site)
  • IVDR technical file creation support, including coaching your team through submissions
  • Presubmission technical file review
  • Creation or review of experimental design for analytical or clinical performance studies to support or remediate technical files
  • Statistical support
  • QMS support to ISO 13485, ISO 15189 or the IVDR
  • Support the implementation of post-market surveillance (PMS) and post-market performance follow-up (PMPF)
Other IVDR services:



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