It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products in the European Economic Area (EEA) must understand and adapt their devices, documentation, and process so that they are compliant under the new EU MDR as well as the IVDR. However, there remains questions regarding the expected changes from the European Directive 98/79/EC (IVDD) to the new IVDR. Here are some common questions answered, surrounding the change in regulation:
1. What is the In Vitro Diagnostic Medical Devices Regulation (IVDR)?
The EU IVDR is the new regulation passed by the EU to improve the efficacy, safety, and quality of in-vitro devices (IVDs) by redefining what an IVD is including its classification, as well as the processes for approval and surveillance.
2. What is the implementation timeline for medical device companies to comply with the IVDR?
While the IVDR was passed in 2017, it is on a 5-year track for full implementation, allowing medial device companies time to adjust to the transition and update their devices and processes accordingly. The official date for implementation is May 26, 2022. Products that are already certified by the regulatory body may remain in the market until May 25, 2024, so long as the manufacturer meets certain conditions and prerequisites under the new IVDR.
3. What are key changes from the IVDD to the IVDR?
The IVDD was originally passed in 1993, and since there have been many advancements for in vitro medical devices. In the new IVDR, some important changes medical device manufacturers should be aware of are:
- Broader definition of IVD: When the IVDR was originally passed in 1993, Software as a Medical Device (SaMD) and programs that used algorithms for a medical purpose were not included. Under the new IVDR, these devices are clearly defined.
- Harmonized classification: IVDs will now be classified based on rules set by the Global Harmonization Task Force System. The new classification rules have four classes: Class A (lowest risk) to Class D (highest risk). Previously, IVDs were mostly under a self-certified, meaning that the Notified Body did not need to review the technical document associated with it.
- Increased surveillance: Notified bodies will increase their surveillance of IVDs to mitigate risks in efficacy and patient safety.
- No “grandfathering” rule: All approved IVDs must be reclassified and certified in compliance with the new regulation.
- Singular person responsible for regulatory compliance: Just as with the EU MDR, under the IVDR, there must be one singular individual as the point of contact between the medical device company and the Notified Body.
- Unique Device Identification (UDI): To improve post market surveillance, each device must have a UDI.
4. What can companies do to prepare for the change?
For medical device companies marketing products in the EEA, it is important for them to fully understand all updates in regulation changes under the IVDR and EU MDR. In addition to gaining a better understanding of the new regulation, medical device companies must create a gap analysis assessment for further clarity on the changes from the IVDD to the IVDR. Companies should also invest in training and educational materials for employees to ensure quality management system (QMS) is up-to-date and compliant with the processes required by the IVDR.
5. Why is translation so important under the new IVDR?
Just as with the EU MDR, the IVDR requires “clear and precise” language regarding all technical documentation submitted to the Notified Body, as well as any patient information materials. These documents must be translated into all 24 official EU languages and must be done so in a way that regardless of who is reading the document, it is understood entirely. In addition, to train employees on the new regulation, global medical device companies will need to provide translated eLearning materials to ensure quality standards are kept in alignment with the new regulation. With so many different documents and languages, it important for medical device companies to partner with an ISO-certified and compliant language service provider (LSP) that has in-depth understanding of the new EU IVDR and MDR to facilitate success for medical device companies seeking market access in the EEA.
If you’re interested in learning more about the labeling requirements of the IVDR, as well as the MDR, check out our white paper on The EU MDR Labelling Journey: Best Practices for Navigating the Latest Medical Device Labeling Requirements!