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CE marking IVDR

We can support you with the transition for IVDD to IVDR 

EU-IVDR

CE Marking for In Vitro Diagnostic

The IVDR (2017/746) is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It replaced the EU’s directive on in vitro diagnostic medical devices (98/79/EC).

The new EU IVD Regulation entered into force in May 2017. It has a great impact on the IVD manufacturers, and the manufacturers of currently approved in vitro diagnostic medical devices had a transition time of up to 26 May 2022 to meet the requirements of the IVDR. 

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How Qserve can help

Our staff has been intimately involved with the development of the new IVD Regulations and can share this inside knowledge with our clients to help create submissions in a Notified Body-friendly format and can guide you through the implementation process from concept to market access. 

 

 

If you need help with your regulatory strategy, technical file preparation, or post-market surveillance, or if you have limited resources, our consultants will educate your team on why and how the IVDR could impact your IVD products.


EU-IVDR services

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We would like to tell you more about the possibilities that Qserve offers for IVDR Services.

Qserve has developed EU-IVDR consulting services and customized training sessions to not only teach the requirements but also educate our clients through hands-on workshops where they gain a greater understanding of what the requirements are, industry best practices, and how to apply these to their own organization.

Fill in our form, and let us inform you about our possibilities.

 

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