Medical device manufacturers in the EU (or trading in the EU) are finding their feet with an updated set of regulations, including the EU Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (EU IVDR).
In this article, we focus on the new EU IVDR requirements and when they’re due to take full effect.
Delayed IVDR implementation dates
The new regulations were due to take full effect from May 2022. This has been amended to allow longer, progressive transition periods. The length of the transition period depends on the type of device.
Class A and B devices
Lower risk devices such as class A and B sterile devices have a transition period until May 2027.
Class C and D devices
The higher risk devices, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have transition periods until May 2025 and 2026 respectively.
Summary of new EU IVDR requirements
For manufacturers wanting to continue supplying IVDs to the EU market, additional work is required to comply with the new EU IVDR.
However, very few requirements are completely new. They’re mainly extensions to existing requirements that bring the EU regulations in line with the regulatory requirements in the rest of the world.
Here are the new EU IVDR requirements.
Scope and device classification
There are still four IVD classes but now they’re segregated into classes from A to D. Classes C and D are for higher risk devices.
Devices containing substances that will be introduced to and/or absorbed by the body will rely on a totally different classification system. Many devices will be reclassified as high risk.
Classification rules
The majority of IVDs used in clinical laboratories or in near-patient testing will move from being “self-declared” to requiring Notified Body assessment under the new IVDR.
Post Market Surveillance (PMS)
Notified Bodies play a bigger role in supervising the manufacturer’s PMS system.
The new EU IVDR introduces a requirement to produce a PMS Report or, depending on the device class, a Periodic Safety Update Report (PSUR).
Unique Device Identification (UDI)
A UDI is already a requirement in the United States and will now be required for Europe.
Role of economic operators
The new EU IVDR provides guidelines for all stakeholders on how to execute assigned duties and help organize responsibilities among importers, suppliers, subcontractors, assemblers, and EU-authorized representatives.
The guidelines bring European importers and distributors in line with already established practises for importers and distributors of medical devices elsewhere in the world.
Compliance manager
At least one person in the organization must be formally assigned responsibility for ensuring the regulatory compliance of the enterprise.
This is not new for organizations with a Quality or Regulatory Compliance or Safety Manager.
Genetic tests
Member states must ensure people who are offered genetic tests are informed about the significance and implications of the test and have access to counseling.
Eudamed database
Under the new EU IVDR, Eudamed (the EU database for medical devices) will now store information regarding post-market surveillance activities, safety and clinical performance studies, and periodic safety update reports.
It will provide more detailed information on clinical investigation data, manufacturers, and device registrations.
IVDR vs IVDD
Visit this site if you want to read a clause-by-clause comparison of the IVDR and older IVDD regulations. Or here if you want to read a white paper that explores the relationship between the IVDR and the IVDD.
QMS requirements for compliance
The IVDR includes new requirements that must be managed within the manufacturer’s QMS. They are:
- risk classification
- conformity assessment procedures
- clinical evidence.
The QMS requirements taken from the new EU IVDR are almost identical to the EU MDR requirements for QMS.
Risks must be reduced as far as possible, taking into account the “state-of-the-art” status of these devices. Manufacturers must identify how a device meets state-of-the-art requirements and provide evidence within its technical file.
Post-market surveillance procedures and activities are a major QMS requirement of IVDR. As you monitor and gather feedback from users, ensure you have a feedback loop system for updating your risk management file in order to effectively monitor the performance of the device.
There are updated clinical data requirements as well as additional clinical evidence requirements that may apply.
What isoTracker offers
isoTracker offers modular, cloud-based quality management software, including document control software, which is validated for the medical devices and healthcare industries. It can help you comply with the new EU IVDR requirements.
Key advantages of isoTracker’s document control software:
Each of our modules can stand alone or integrate with other modules to provide a complete quality management system.
Contact us to find out more about automating document control using our document management software. Alternatively, go ahead and sign up for a free 60-day trial of isoTracker’s quality management software.
