The EU-IVDR got into force
The In Vitro Diagnostic Regulation (IVDR) is the new regulatory basis (EU) 2017/746 for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. The regulation aims to ensure a high level of protection of public health, patients, and users.
It replaced the EU’s Directive on in vitro diagnostic medical devices (98/79/EC) and introduced substantial changes in the sector. The IVD Regulation applies from 26 May 2022. There are transitional agreements to provide more time for conformity assessments to take place; this is required whilst the IVDR infrastructure is being implemented and ensures the availability of in vitro diagnostics on the EU market, but does not apply to all devices.
There is still an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers should recognize the IVDR is more complex and detailed and will, therefore, require more resources to maintain as well as implement.
New arrangements to meet the requirements of the IVDR have been adopted. It does not change any requirements of the IVDR but only extends the time available to complete the conformity assessments with Notified Bodies, which depends on the type of device. There is a lot to consider, but it is really important, don't take your foot off the gas, there's still a lot of work to do.
Read more about the transitional arrangements, what elements should be in place after the 26th of May and how to meet the IVDR.
How to meet the IVDR
Key changes of the IVDR
One of the main changes is the involvement of Notified Bodies for conformity assessment, where in vitro diagnostics will be under control. Another change is that in-house devices need an appropriate quality management system (QMS).
The transition will require an enormous amount of work. Qserve's practical approach helps to guide you through the complete implementation process. Our top consultants will bring the interpretations to you.
Key changes IVDR
Interested in our IVDR services?
Qserve is here to support you on this journey, using our expertise to understand the requirements. Our staff is intimately involved with the development of the new IVD Regulations and can share this inside knowledge to help create submissions in a Notified Body-friendly format and can guide you through the implementation process from concept to market access.
Analytical and Clinical Performance for IVDs
In-vitro diagnostics can appear to be even more challenging than “rocket science”, but the reality is that we just need good science. This webinar will explore the tools of design control, as well as touches on how we use good science before we step into the lab to lay out what the design needs to achieve given the intended use we want to claim.
- Use the design control elements to help them organize and manage the work that needs to be done to develop an IVD product.
- Understand how the analytical studies are related to the accuracy claim for the product.
- Use the required accuracy for the product to determine the acceptance criteria for the analytical studies.
Join the Free Webinar on the 21st of September.
“The IVDR is an enormous change to the IVD industry, many are calling it a cultural shift. Not only does it requires a significant change to technical documentation and the quality management system, but it includes a new requirement for economic operators which changes their responsibilities and also the relationship the manufacturer currently has with them.“
Sue Spencer | Head of IVD & Principal Consultant