News Category: Regulatory news
Regulation (EU) 2017/746, known as the In Vitro Diagnostic Medical Devices Regulation (IVDR), comes into effect in the European Union today, 26 May 2022.
The IVDR changes and strengthens the regulatory system for in vitro diagnostic medical devices (IVDs) in the EU. IVDs are devices used to perform tests on biological samples to determine the status of a person’s health. IVDs include a broad range of devices, from self-tests for pregnancy and blood glucose tests for diabetics, to sophisticated diagnoses performed in clinical laboratories.
The IVDR will ensure that IVDs meet high standards of safety and effectiveness for the people who use them. It will do this by creating a more effective, transparent and robust system for regulating IVDs across Europe.
The IVDR will complement the Medical Devices Regulation (MDR), which came into effect in 2021 to improve the regulation of medical devices. Together, the IVDR and the MDR replace the rules created in the 1990s and respond to the substantial technological and scientific progress in the devices sector in recent years.
As the new legislation is in the form of a Regulation rather than a Directive, it can be applied directly at national level. This allows for greater legal certainty and prevents variation in the rules for IVDs across EU Member States. This means that the same high standards of safety and effectiveness will apply to all IVDs available in the EU.
Key changes to ensure safety and effectiveness of IVDs
The IVDR introduces a wide range of measures to ensure the safety and effectiveness of IVDs. Some of these measures are outlined below.
The IVDR introduces a classification system for IVDs. IVDs will now be classified into four classes based on risk from class A (low) to class D (high). Higher-risk IVDs will undergo stricter checks for safety and effectiveness. For example, class B, C and D IVDs will be independently assessed by organisations known as notified bodies to ensure they meet safety and performance requirements before being placed on the market.
Higher-risk devices will also require more clinical evidence to demonstrate that they meet the necessary standards. Clinical evidence refers to both clinical data and performance evaluation results and assesses if a device is safe and achieves the intended clinical benefit when used as instructed by the manufacturer.
New EU reference labs will be established to promote consistent methods for analysis, testing and diagnosis. These labs will carry out tasks such as verifying if a device performs as claimed by the manufacturer.
The IVDR further strengthens and clarifies obligations for the continued safety monitoring of IVDs on the market both by manufacturers and by regulatory authorities, such as the HPRA. After a device is placed on the market, manufacturers must continuously update information about risk analysis and clinical evidence about IVDs. The HPRA, and other regulatory authorities in the EU, must ensure that effective market surveillance systems are in place at national and European level.
The IVDR introduces safety and performance requirements for IVDs manufactured and used within healthcare institutions (i.e. ‘in-house’ IVDs). Such tests may be developed due to a lack of commercially available alternatives e.g. for rare diseases. Requirements will include justifying the use of in-house devices and ensuring that an appropriate quality system is in place.
A new IT system for IVDs known as Eudamed will collate information about IVDs and companies in the IVD supply chain. This will enhance transparency by providing information for the public and healthcare professionals about the safety and effectiveness of IVDs available in the EU. Additionally, the information in EUDAMED will support collaboration among EU Member States. For additional information about Eudamed, please see the Commission’s Eudamed information webpage.
HPRA role in implementing the IVDR in Ireland
The application of the IVDR today is a landmark development, delivered following years of collaborative work between the European Council, the European Parliament and the European Commission. We have been preparing for the implementation of the IVDR in Ireland through engagement with the Commission and the Department of Health. Together, we will work to ensure that the IVDR is implemented effectively and that the legal, resource and system requirements are all put in place at national level.
Stakeholder engagement and support
We have engaged with relevant stakeholders to clearly communicate the requirements of the IVDR to ensure they are correctly understood and implemented on time. We are committed to working closely with affected stakeholders on implementation and will continue our regular dialogue with the industry and trade associations in Ireland.
We continue to develop and publish guidance for stakeholders regarding the application of IVDR requirements. Current resources on our website include:
We encourage engagement from all stakeholders on the new legislative requirements. We have a dedicated mailbox for queries relating to the implementation of new Regulations. For implementation queries, please email us at email@example.com.