EU IVDR In Vitro Diagnostics Regulation in Europe

Our global In Vitro Diagnostic regulatory consulting specialists offer tailored IVDR compliance services.

EU IVDR

The EU IVDR  

The In Vitro Diagnostic Regulation 2017/746 (EU IVDR) is the new regulatory basis (EU) for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. The in vitro diagnostic 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 it does not apply to all devices.  

There is still an enormous amount of work required to transition from the IVDD to the IVDR, and manufacturers should recognize that the IVDR is more complex and detailed and will, therefore, require more resources to maintain and implement. 

 

 

 

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Transitional arrangements EU IVDR

The core requirements of the EU IVDR have not changed since it was published, however, amendments have been made which include an extension to the transitional arrangements making additional time available to complete the conformity assessments with Notified Bodies. Class A non-sterile devices do not require a Notified Body, and there is, therefore, no transition for these devices, and the EU IVDR already applies in full.

Read more about the transitional arrangements, which include additional requirements to notify Competent Authorities if devices are to be withdrawn from the EU market.
 
How to meet the IVDR

Key changes of EU IVDR

There are two significant changes between the IVDD and the EU IVDR. Firstly the implementation of a classification based on, but not identical to, the IMDRF classification. This introduces a risk-based classification A to D, with D being the high-risk devices. The second significant change is the introduction of increased Notified Body oversight for class B, C, and D devices plus class A sterile. These devices now need an audit of the quality management system (QMS) and a review of the technical file. 

The EU IVDR is very prescriptive, and as a result, the transition will require significant effort and attention to detail. Qserve's practical approach helps to guide you through the complete implementation process and find the most efficient way to meet the new requirements. Our consultants will support your implementation by sharing their hands-on experience.  

Key changes IVDD vs IVDR

Interested in our EU 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 IVDR 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.

IVDR services 

Analytical and Clinical Performance for IVDs

In-vitro diagnostics can at first appear to be even more challenging than “rocket science,” but the reality is that the best way to achieve compliance is through good science. This webinar will explore the tools of design control, as well as touch 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 process to help companies organize and manage design and development to support market access in all regulated markets. 
  • 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 On-Demand recording of the Free Webinar.


More information



“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

 

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