In 2016, the European Commission decided to gradually introduce a new mandatory regulatory framework for IVDs: IVDR (In Vitro Diagnostic Medical Device Regulation). The new regulations will replace the old In Vitro Diagnostic Medical Devices Directive IVDD on May 26, 2022.
We know that it can be overwhelming to get an understanding of the new requirements. Since we at Key2Compliance have both courses and consultant services on the topic, we are accustomed to guiding our clients to smart and efficient solutions. In this article you will find the most important changes.
What’s new under IVDR?
IVDR makes some substantial changes in the regulatory framework for in vitro diagnostic medical devices. While IVDD covered 37 pages, IVDR summarizes a larger overall regulatory framework of 157 pages. What used to be mostly recommendations with room for interpretation has now become a common regulatory framework, raising the requirements for the CE-IVD within the European region. The aim of the new regulations is to increase patient safety.
Some of the more important changes are:
- IVDs are sorted after new rule-based risk classification system with four classes from low public health and personal risk to high public and personal health risks: A, B, C, D. The rules in Annex VIII of IVDR will guide the IVD manufacturers in determining
- Notified Bodies will play a more important role in monitoring whether IVDs comply with the requirements. Most devices will now require a conformity assessment by a Notified Body (an independent organization that assists the manufacturer’s work through testing, inspection, and certification). Only manufacturers of non-sterile Class A devices can self-certify under IVDR.
- The database EUDAMED will be used to monitor the safety and performance of devices under IVDR. The traceability that comes with mandatory registration of products will further increase patient safety.
- There will be clearer requirements for manufacturers and laboratories. CE-IVD-labeled tests will have priority over self-manufactured tests (LDT). It is not allowed to manufacture own products when there is a corresponding CE-marked product on the market. The use non-CE-IVD-labeled alternatives must be justified.
- The postmarket surveillance requirements in IVDR have increased and are more rigorous than in IVDD. Manufacturers are now required to proactively collect and evaluate relevant data from the use of the devices.
- IVDR require that all IVD manufacturers must implement and maintain a QMS (Quality Management System). Including those that are manufacturing Class A devices.
Timeline for the implementation of IVDR
Due to the situation caused by the COVID-19 pandemic and a shortage of Notified Bodies, the European Commission proposes a delay in the implementation of IVDR, providing a progressive roll-out to avoid disruption in the supply of IVDs. The new regulations will still go on effect May 26 2022, but to begin with the regulations will only apply to new IVDs that are not already on the market, and and to Class A non-sterile devices that doesn’t require the involvement of a Notified Body. For all other IVDs there’s a transition period depending on device class. Class D devices will have until May 2025, Class C devices until May 2026, and Class B and Class A sterile devices will have until May 2027 to comply with IVDR.
We can help you comprehend what actions are necessary and support you on the entire CE marking process for IVDR! Contact us to learn more about how we can help.