In-vitro medical devices Regulation (IVDR)
The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure the safety and performance of in-vitro diagnostic medical devices on the European market.
The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without being transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
Impacts of the IVDR
Significant impacts of the IVDR include greater transparency, extended scope, increased oversight, heightened traceability, stricter requirements, and analytical performance and scientific validity. These additional requirements have caused significant increases in workload across the medical device value chain.
Some of the critical changes in the IVDR
- Product scope expansion
- Reclassification of devices according to risk
- More rigorous clinical evidence
- Self-testing and near-patient testing devices will be subject to a premarket approval approach.
- More stringent documentation.
- Identification of ‘person responsible for regulatory compliance’ (PRRC)
- Implementation of unique device identification (UDI)
- Requirements for post-market surveillance will be reasonably increased, and the general timeline for reporting reduced.
- More rigorous oversight by Notified Bodies
The complex development process for in vitro diagnostic medical devices, combined with a high degree of new requirements, have made the IVDD to IVDR transition a complicated and time-consuming process for most device manufacturers.
Manufacturers of in vitro diagnostic medical devices should:
- carefully study the requirements of the new IVDR
- perform an assessment of how their current product portfolio may be impacted by the new regulation
- start clinical performance studies to ensure sufficient clinical evidence are available for their products