PentaBase has been working hard to transition from In-Vitro Diagnostic Medical Device Directive (IVDD) to In-Vitro Medical Devices Regulation (IVDR) before the 25th of May 2022 with the new EU Regulation on Medical Devices. To ensure compliance with the IVDR, all IVD devices with a CE mark and class A self-declared devices must meet the requirements of the IVDR to be on the European market.
What is the IVDR?
The In-Vitro Medical Devices Regulation (IVDR) is the new framework to ensure the safety and performance of IVD medical devices in the European Market to improve clinical safety for manufacturers and healthcare professionals and strengthen patient safety. The transition already began on the 25th of May 2017, marking the start of a five-year transition period for manufacturers 1.
What are the fundamental changes from IVDD to IVDR?
The IVDD’s regulatory classifications were based on the conditions or the design of the diagnostic medical device. It was categorised into different levels of lists and annexes within the IVDD, corresponding to the different levels of regulatory compliance and standards that the products should have to comply with. The difference between IVDD and IVDR is the classification system for medical conditions and the regulatory categorisation of medical devices 2. Because the IVDD relied on a predetermined list of medical conditions, it was harder to react in case of emergencies of newly found pathogens or the traceability of the products that the manufacturers have on the European Market.
The IVDR uses a risk-based classification scheme that assigns diagnostic medical devices to one of four classes – A to D; based on the risk scale, a malfunction of an appliance can affect the patient. To better understand the changes the IVDR will add to the medical device registration, we will share some of them with you:
- Reclassifications of devices
- Class C/B; Assessment of Technical Documentation
- Clinical evidence: As manufacturers of medical devices, we will need to conduct clinical
- Performance studies provide evidence of safety and performance according to the risk class, our products are categorised.
- All the medical devices we manufacture will have to contain a unique device identification for better traceability and recalls.
- Post Market Surveillance has a higher role now compared to IVDD.
The main reason why the rules have been tightened for medical devices performing tests on patients is to give patients the availability of documented evidence of the device’s performance.
As a science-driven company, we commit to developing and enabling personalised treatments using sensitive, specific, and robust monitoring of genetic biomarkers in patients. Because we believe every patient is unique and deserves to be treated individually. Therefore, we are responsible for showing transparency and liability to you concerning our medical devices, such as SensiScreen®, Microsight MSI, and PlentiPlex.