1. WHAT IS THE IVDR?
The IVDR regulation replaces the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states.
2. WHEN DOES IMPLEMENTATION TO THE IVDR START?
The IVDR was published on 5 May 2017 and entered into force on 26 May 2017.
3. WHEN DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY TO THE NEW IVDR?
Products that do not currently hold an IVDD NB certificate must complete their transition to the IVDR by 26 May 2022. Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid, subject to surveillance by the Notified Body who had issued it and no significant changes to the product are made.
4. WHAT ARE THE KEY CHANGES EXPECTED IN THE NEW IVDR?
- Product scope expansion. The scope has been clarified to include products and services placed on the market using the internet and diagnostics that predict treatment response or reactions and clearly described in the scope
- Reclassification of devices according to risk. Risk classes will range from Class A for low-risk devices to Class D for high-risk devices. Many more products will be in high-risk classes and require Notified Body review
- More clinical evidence. Manufacturers will need to produce data from clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class. Common Specifications will be required for a larger range of devices and independent testing by a reference laboratory to show compliance will be required.
- Self-testing and near-patient testing devices will be subject to a premarket approval approach.
- More presctiptive requirements for technical documentation.
- Identification of ‘person responsible for regulatory compliance’
- Implementation of unique device identification for better traceability and recall
- Requirements for post-market surveillance will be reasonably increased and a general timeline for reporting reduced.
- More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
- No “grandfathering” provisions. All currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.
5. WHAT ARE THE IMPLICATIONS OF THE NEW IVDR FOR IN VITRO MEDICAL DEVICE MANUFACTURERS?
The IVDR will require every technical file to be rewritten to meet the new requirements, expectations have increased significantly. Expectations for the supply chain have also increased so implementation of the IVDR will have far-reaching effects impacting all IVD stakeholders