The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this directive, all products of all classes that stay on the market after May 26, 2022 must be reassessed for IVDR compliance to ensure that those products are fit for purpose and safe to use. There is no automatic pass granted based on the time that a product has been on the market—no “grandfathering” is permitted. Notified Bodies and manufacturers must be prepared to market products in an environment now requiring greater control and oversight.
The IVDR is a newly implemented regulatory component of the EU Regulation for medical devices (MDR). It replaces the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC) to help ensure the safety and efficacy of in vitro diagnostic devices available and in service in the European market.
While technically not a new regulation—it came into force back in May, 2017—it has not yet been fully enacted. With most key components in place or in-process, May 26, 2022 is the date after which all devices must be in compliance. However, products already certified by a Notified Body (NB) are allowed in the market until May 25, 2024 under specific conditions and if the manufacturers fulfill particular prerequisites indicated in the IVDR.
Compared to the IVDD that it replaces, the IVDR promotes a shift from the pre-approval stage (i.e., the path to CE Marking) to a life-cycle approach. This is similar to the life-cycle view preferred by the US Food and Drug Administration and advanced by many international standards.
The biggest change is the introduction of a risk-based approach to classification in addition to increased NB oversight. The Regulation identifies four new risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk) aligned with IMDRF/GHTF IVD classification guidance. Under the current regulations, most IVDs are self-certify, thus a NB does not have to review the technical file. There are very few delays. With IVDR most IVD will not be self-certified and instead will fall into Class B, C, and D IVDs which will require NB intervention as part of their conformity assessment. Technical files and clinical evaluation reports that have been used for years. Medical device companies will need to be revised to meet the new regulations. This will also increase the strain on NB resources, in addition to the extra work caused by the MDR.
Here’s a quick look at some of the key provisions included in the IVDR:
- Expanded product scope
- More rigorous clinical safety and performance evidence
- Device reclassification according to risk (see previous paragraph)
- Pre-market approval of self-testing and near-patient testing devices
- More stringent technical file documentation
- Identification of “person responsible for regulatory compliance”
- Implementation of unique device identification
- Increased post-market surveillance requirements
- Reduced general timeline reporting
- More rigorous surveillance by NBs
- Greater scrutiny of NBs
- No device “grandfathering”
Clearly, the IVDR will address several weaknesses of the IVDD and bring significant regulatory changes for IVD manufacturers selling in Europe. With substantial changes occurring in less than two years, proactive IVD companies are working now with a medical device consultant and planning a regulatory strategy to be fully prepared.
If you’d like to know more or learn how your company can prepare for these regulatory revisions, contact the EU regulatory compliance experts here at MEDIcept.