The IVDR is set to replace the IVDD in order to adapt to more technical/scientific requirements for IVDs to be placed in the EU countries. About 80% general IVD in the market will be subjected to new EU notified bodies conformity assessment.
The European Commission and national authorities currently focusing the following high importance items, with expectation of more than 80 guidance on : Performance evaluation and clinical evidence,
Classification rules and its examples, Notified Bodies designation, Vigilance reporting.
*Important Note: There will be a hard stop sale of IVDD self-declared General IVDs on 26 May 2022. IVDs can be placed in EU market under IVDD till 2025 but only for existing IVDs of higher risks that have undergone conformity assessment and with no upcoming significant changes.
See the Summary Timeline of IVDR and its pointers as below.
Summary Timeline of EU IVDR
Summary Pointers of EU IVDR
1. Scope & Definitions
On top of only IVDs & accessories, the IVDR now covers companion diagnostics, regulates in-house tests and on-line sales as well as software. The expansion of the scope and definition is to cover previously unregulated products in order to adapt to the changes brought about by scientific progress.
2. Stakeholders in the system
Other than the Notified Bodies and Authorities, the IVDR now includes new bodies such as MDCG, EMA and reference laboratories as stakeholders. The roles for distributors and importers are also explicitly stated.
The IVDR now classifies IVDs into Class A to D. With class A as the lowest risk to Class D as the highest risk, which will be largely GHTF-based.
4. Safety and Performance Requirements
The safety and performance requirements are now expanded with more in-depth details. as well as encompassing harmonized standards and common specifications within the IVDR. Clarification of performance indicators are now provided, including Scientific validity, Analytical performance and Clinical performance which will be part of a Performance Evaluation Report (PER).
5. Evidence Requirements
Clinical evidence now requires more details to be collected and analyzed throughout the entire life cycle of an IVD. Evidence sources must be clarified and clinical performance are required unless justified. Manufacturers now have to establish and maintain a PER based on the clinical evidences.
6. Performance Studies
High risk clinical performance studies are now defined and requirements are now more detailed and extensive. The studies conducted must be authorized by authorities and the ethics committee.
7. CE-marking/ Conformity Assessment (CA)
Notified Bodies are now involved for all Class A sterile, B, C and D IVDs. The EMA and reference laboratories are also involved as well. This will expand the scope of IVDs covered by the Notified Bodies from 20% of all of IVDs under IVDD to 80% under IVDR.
8. Post-market obligations
Manufacturers are now required to devise a post-market follow-up plan and continuously update the PER. This will promote better prevention or handling of adverse events and subsequently improve the quality and safety of IVDs.
9. Transparency and Traceability
EUDAMED will be accessible to stakeholders and the public on top of only to authorities. Data from clinical performance studies and Class C and D IVDs is now accessible to promote transparency. The UDI system is also in place to ensure traceability in the supply chain.
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