If you work with in vitro diagnostic medical devices, you will probably already be familiar with the IVDR.
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 replaced the previous In Vitro Diagnostic Medical Devices Directive (IVDD) and brought significant changes to the way IVDs are regulated in the European Union.
The IVDR has been in force since 26 May 2022. For manufacturers and others working with IVDs, it has meant changes to classification, performance evaluation, clinical evidence, conformity assessment and post-market surveillance.
But what are the main changes, and what do they mean in practice?
A New Risk-Based Classification System
One of the biggest changes introduced by the IVDR is the new classification system.
Under the IVDD, IVDs were divided into a smaller number of categories. The IVDR instead uses a risk-based system with four classes:
- Class A, the lowest risk
- Class B
- Class C
- Class D, the highest risk
Classification is based on seven rules set out in the regulation and determines the requirements that apply to the device.
It also affects the conformity assessment route and whether a notified body needs to be involved.
For some manufacturers, this has been a major change. Devices that could previously be self-declared under the IVDD may now require notified body assessment under the IVDR.
Performance Evaluation And Clinical Evidence
The IVDR also places greater emphasis on demonstrating the performance of an IVD.
Manufacturers need to provide evidence that their devices meet the applicable General Safety and Performance Requirements and are suitable for their intended purpose.
Performance evaluation covers three areas:
- Scientific validity
- Analytical performance
- Clinical performance
The evidence supporting an IVD is not simply something that is gathered before the device reaches the market. Performance evaluation is an ongoing process and needs to take account of new information as it becomes available.
The IVDR also introduced more detailed requirements around performance studies. Depending on the device and its intended purpose, manufacturers may need to carry out performance studies to generate the evidence required to demonstrate clinical performance.
Post-Market Surveillance And PMPF
Another important change is the increased focus on what happens after an IVD reaches the market.
Manufacturers are required to establish and maintain a post-market surveillance system that is appropriate to the device and its risk classification.
This involves collecting and analysing information about the quality, safety and performance of the device. The findings can then feed into areas such as risk management, performance evaluation and technical documentation.
The IVDR also introduced specific requirements for post-market performance follow-up, or PMPF.
PMPF involves proactively collecting and evaluating performance and scientific data from devices that are already in use. The aim is to confirm that the device continues to perform as intended and to identify any previously unknown risks or limitations.
This ongoing approach is an important part of the IVDR and means that regulatory responsibilities continue throughout the life of the device.
Why Understanding The IVDR Matters
The IVDR affects more than just regulatory affairs teams.
Depending on the organisation, people working in quality, clinical and performance functions, product development, manufacturing and post-market surveillance may all need to understand how the regulation affects their work.
You do not necessarily need to be a regulatory specialist. What is useful is having enough knowledge to understand the requirements that apply to your role and how your work fits into the wider regulatory process.
This is particularly relevant for organisations moving from the IVDD to the IVDR, where some of the requirements and processes may be very different from those that teams have worked with previously.
Our New IVDR Course
We have launched our new online In Vitro Diagnostic Medical Devices Regulation (IVDR) course to help professionals develop their understanding of the regulation and how it applies to IVDs.
The course provides a clear introduction to the key requirements of the IVDR, including classification, performance evaluation, clinical evidence and post-market responsibilities.
Whether you are new to the IVDR or want to refresh your existing knowledge, the course is designed to give you a solid foundation for working with the regulation. Find out mroe here.
