Expectations on Manufacturers to Demonstrate the Safety and Consistent Performance of Medical Devices
For molecular diagnostics manufacturers, distributors, and users throughout the European Union, the introduction of the European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR) has been a looming reality. Initially introduced in 2017, the EU IVDR fully took effect on May 26, 2022, intending to set higher standards for the quality and safety of IVD products. These requirements expanded upon IVD Directive 98/79/EC (IVD-D) Requirements, which took effect in 1998, and place greater expectations on manufacturers to demonstrate the safety and consistent performance of medical devices.
Transparent and Sustainable Regulatory Framework
According to its commissioners, IVDR requirements will create a transparent and sustainable regulatory framework that “improves clinical safety and creates fair market access for manufacturers and healthcare professionals.” But what do these regulations actually mean for the industry? While many IVD-D requirements remain in effect, IVDR can pose significant changes for the in-house creation of molecular diagnostic (MDx) assays. This blog will outline the changing regulatory landscape for in-house assays under IVDR and how Thermo Fisher’s products and services can support customers during this change.
Changing the Regulation of Molecular Diagnostic Assays
Under IVD-D requirements, assays created in-house using components such as research use only (RUO) reagents or adapted IVDs were not subject to EU regulation. Specifically, these unregulated tests were defined as assays developed by individual labs for very specific patient conditions that lack a commercially available test. The IVDR will now encompass these in-house assays as well as previous CE-IVD materials to hold both to the same safety and quality standards in an appropriate manner. This means that any new IVD devices placed on the market as of May 26th must be CE marked according to IVDR guidelines and that in-house assays will also be subject to stringent regulation.
What Are the Practical Implications of IVDR for In-House Assay Providers?
Safety, Quality, and Consistency of Products
Because demonstrable safety, quality, and consistency of products are the chief priorities behind the IVDR changes, in-house assays developed by clinical labs will be harder to validate and justify for use. Some of the requirements for adherence to these guidelines include:
Products must comply to the IVDR Annex 1 General Safety & Performance Requirements
Groups that create an in-house assay must demonstrate and document its safety and performance according to the IVDR Annex 1 General Safety & Performance Requirements. These requirements set expectations for safe manufacturing, reliable performance, and accurate labeling and standardization of IVD products. Groups are not required to submit any documentation for verification of compliance prior to use of the in-house product but must have such documentation available for review by Competent Authorities (CA) when requested. While the manufacturing and use of in-house assays under these quality management requirements will not be much of a burden for labs already complying with ISO 15189:2012, smaller labs lacking accreditation may face challenges doing so.
Devices may not be transferred to another legal entity or made on an industrial scale
In-house assays cannot be sold to a third party for distribution. If a developer does elect to sell an in-house assay, they must become an IVD manufacturer and work under the full scope of IVDR guidelines. Though lab-developed assays themselves cannot be sold to another group, clinical labs may share or communicate test results to a patient’s health institution. Additionally, the product is permitted for in-house use only and may not be manufactured on an industrial scale. “Industrial scale” production is understood as continuous production for a commercial purpose.
By the year 2028, labs must provide justification for why a CE-IVD device available on the market isn’t usable
As of 2028, to use an in-house assay under IVDR, labs must provide reasoning unrelated to financial factors for not using a CE-IVD device already available on the market. This is intended to allow for the development of tests for rare conditions where more widely available products cannot meet specific patient needs. If an equivalent alternative is available on the market, a lab must rethink its strategy, either discontinuing the assay, using the commercially available option, or placing its own assay on the market as a CE-IVD product.
Developers must provide more extensive documentation
Another major change under IVDR is the demand for greater documentation surrounding an in-house assay and its use. Local Competent Authorities responsible for policing IVDR compliance may request extensive information for both new and existing in-house assays, including manufacturing information, design specifications, intended use, performance data, justification for use, and more. Depending on national provisions, labs may also be required to inform Competent Authorities when an in-house assay is first introduced into use, modified, or discontinued. To facilitate compliance with the IVDR, labs should prepare to provide this information immediately for any tests in use or under development.
Applied Biosystems QuantStudio 5 Dx Real-Time PCR System
Users Are Supported Through the Transition
CE-IVD Certified and Self-Registered Under IVDR Regulations
To make compliance simple for labs creating their own real-time PCR (qPCR) MDx assays, the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System (CE-IVD, IVDR) is CE-IVD certified and self-registered under IVDR regulations. This flexible, open platform minimizes the need for “bridging studies” during test development, as labs can use the same instrument for assay development and clinical testing.
Multi-Mode Software & Centralized SAE Admin Console
Supports RUO and IVD Workflows, Meets IVDR Cybersecurity Requirements
QuantStudio 5 Dx (CE-IVDR)’s multi-mode software supports RUO and IVD workflows and provides standardized security features that meet the demands of the IVDR. Its network connectivity meets IVDR cybersecurity requirements, and centralized security, auditing, and e-signature (SAE) management help ensure consistent compliance across devices.
Easily Update Configurations Across Multiple Systems
Additionally, the centralized SAE Admin Console makes it simple to update configurations across multiple systems if regulatory requirements change over time. QuantStudio 5 Dx (CE-IVD, IVDR) is also equipped to save time and resources with required regulatory documentation, making thorough performance evaluation and detailed results reporting available at your fingertips.
Easy to Use Features, Flexible Workflow, Multi-Language Interface
Simple & Efficient Compliance With Dedicated Thermo Fisher Global Support
Additionally, the device’s large touchscreen with a simple, flexible workflow and multi-language interface makes it easy for non-English speakers throughout the EU to operate and troubleshoot. While the QuantStudio 5 Dx (CE-IVD, IVDR) is designed to make compliance simple and efficient, Thermo Fisher’s dedicated resources can provide ongoing global support and training throughout the IVDR transition process to facilitate continued performance. Even for new labs, an IVDR-compliant instrument enables operation into the future, regardless of any eventual updates to IVDR parameters, to a degree that current IVD-D qPCR instruments cannot. The QuantStudio 5 Dx (CE-IVD, IVDR) is designed to keep labs flexible and competitive for years to come, no matter how their needs change.
Moving Forward Together Under IVDR
CE-Marked Instruments – Increased Quality and Safety
QuantStudio 5 Dx (CE-IVD, IVDR)
The advent of IVDR enforcement brings many changes meant to increase quality and safety for patients. While qPCR MDx labs can adapt with existing equipment, assay developers can help ensure compliance within a changing regulatory environment with an instrument that is CE-marked under IVDR. The compliance features of QuantStudio 5 Dx (CE-IVD, IVDR) can maintain performance while adhering to new regulations and let users leverage the support and expertise of Thermo Fisher as they get acquainted with the transition.
Visit thermofisher.com/quantstudio5dx to learn how the QuantStudio 5 Dx (CE-IVD, IVDR) can help usher your lab into the future of IVDR.