In Vitro Diagnostics in Europe

Our global team of IVD professionals are In Vitro Diagnostic regulatory consulting specialists offering tailored IVDR compliance services

EU IVDR

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. 

 

 

 

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Transitional arrangements

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.

IVDR services 

Meet our IVD experts

A unique opportunity to meet the global IVD team in person in the UK to discuss: Going global with your IVDs. How to leverage your IVDs across global regulatory systems. We will guide you in market access for IVDs in the United States, Europe and going global in other countries. 

Learn all about the IVDR regulations, insights and lessons learned so far and the best approach to enter the US market working with the FDA. 

Join this 1-day in-person event in the UK on Wednesday the 1st of February. Expand your knowledge.

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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