Euformatics’ has recently achieved ISO 13485:2016 certification by demonstrating its commitment to quality and safety. It plays an important role in the device registration process of genetic testing devices. Euformatics Quality Engineer illustrates what the certification means, why it’s important and how it helps in IVDR transition journey.
What does it mean to be ISO 13485:2016 certified and why is it important?
ISO 13485:2016 is an international standard that provides requirements for a quality management system (QMS) for organizations involved in the design, manufacture, installation, and servicing of medical devices and in-vitro diagnostics devices.
This certification is important for medical devices as it ensures patient safety, increased customer satisfaction, and regulatory compliance. It is recognized by regulatory authorities around the world. This means that companies that are ISO 13485:2016 certified are often able to smoothly streamline their regulatory approval process.
What is IVDR?
In Vitro Diagnostic Regulation (IVDR 2017/746) will replace IVDD starting from 26th of May 2025, and will be legally binding. This affects all IVD devices in the EEA but also has a global impact, since CE marking is recognized around the world. The IVDR has been designed to increase the safety and effectiveness of in vitro diagnostic devices.
What are the challenges and current status of IVDR transition in Europe?
Initial transition timeline for IVDD to IVDR was May, 2022. IVDR is more stringent than the previous IVDD and includes a number of new requirements which includes software and systems used for in vitro diagnostic purposes. A risk-based classification system has been used for IVD devices to determine the level of conformity assessment required.As a result, a greater number of devices will be assessed by notified bodies, making the manufacturing and distributing of devices more regulated and transparent.
These notified bodies are independent conformity assessment bodies within the EU that have been granted the credentials to assess and decide if IVD devices in the EAA comply with the IVDR. Under IVDR all B, C, and D IVD devices to be assessed by a notified body. This has a huge impact, as under IVDD, only around 20% of devices required notified bodies in the CE-marking process while under IVDR this number grows to 80%.
The IVDR transition has been a major challenge for manufacturers of IVDs. Many manufacturers have had to make significant changes to their products and their quality management systems in order to comply with the new regulation.
In addition to the highlighted challenges, manufacturers are also facing challenges with the availability of Notified Bodies.Since the new guidelines increased involvement of notified bodies in the process from 20% to 80%. The number of Notified Bodies that are accredited to assess IVDs under the IVDR is limited ( approximately 22), and this has led to delays in the certification process.
There is no central registry of IVDD devices in Europe, so it is difficult to quote the exact number. However, the MedTech Europe survey of IVD manufacturers in February 2023 estimated that around 34% of IVDD devices have been transitioned to IVDR. This means that around 66% of IVDD devices still need to be transitioned to IVDR before the end of the transitional period (May, 2025). According to the present scenario it is evident that about 33% of the remaining devices will be transitioned to IVDR yearly (before May, 2025) to achieve the goal (i.e 100% transition).
How does ISO 13485:2016 certification help in moving towards IVDR compliance?
ISO 13485:2016 is harmonized with the EU In Vitro Diagnostic Medical Device Regulation (IVDR), which means that organizations that are certified to ISO 13485:2016 are considered to be compliant with the essential requirements of IVDR regulations.
The IVDR sets stricter requirements for the design, manufacture, and marketing of in vitro diagnostic (IVD) medical devices. It states that organizations must have a QMS in place that meets the essential requirements of the regulation. ISO 13485:2016 certification is a recognized way to demonstrate compliance with these essential requirements. The standard covers many of the same topics for example: Risk management, Quality assurance, Post market surveillance etc. as the IVDR.
Overall, ISO 13485:2016 certification is a valuable tool for organizations that are looking to improve their quality management system, demonstrate compliance with the IVDR, and gain a competitive advantage.
The future of Genomics Hub
As we transition the Euformatics Genomics Hub to IVDR in the coming months and get it certified it will help our customers feel confident that they are powering their clinical diagnostics workflow with a thoroughly audited and approved tool for that intended purpose. This is quite important as the whole healthcare industry is expected to move more and more towards precision medicine and genetic testing using NGS technologies will play a key role in that transition.
In addition to the core workflow from raw NGS data to patient report being IVDR compliant and certified the Genomics Hub will also help our customers in achieving and keeping their accreditations and certifications. Clinical laboratories participate regularly in External Quality Assessment (EQA) rounds to confirm that their operations are producing high quality data i.e. they find all the variants from the patient samples. This proficiency testing is provided by organizations such as EMQN and GenQA and is operated on top of Euformatics quality control platform. In addition to participating in annual EQA rounds and crossing their fingers for good results laboratories can use the quality control platform on a daily basis to ensure consistent high quality output.
Measuring quality is especially important for Lab Developed Tests (LDTs) in the context of IVDR. As requirements for genetic testing become more stringent with IVDR, laboratories need to provide consistent evidence that custom panels designed by them provide safe and efficient results for the patients. Regular validation runs coupled with comprehensive QC for every sample using Euformatics Genomics Hub modules can provide evidence and confidence that clinical laboratories are operating on optimal quality level.