The impact of the COVID-19 crisis is significant across countries in Europe. Hospitals are struggling to cope with the epidemic, while the number of patients is growing by the minute. Here at Obelis, we are making a concrete contribution in assisting organizations to take swift actions to address the challenges we are facing.
We are proud to empower IVD manufacturers to truly make a difference by rapidly notifying your devices on the European market.
The impact of the COVID-19 crisis is significant across countries in Europe. Hospitals are struggling to cope with the epidemic, while the number of patients is growing by the minute. Here at Obelis, we are making a concrete contribution in assisting organizations to take swift actions to address the challenges we are facing.
We are proud to empower IVD manufacturers to truly make a difference by rapidly notifying your devices on the European market.
Continuous regulatory support
Continuous regulatory support
Communication with the Ministry of Health
Communication with the Ministry of Health
Professional E.A.R. services
Professional E.A.R. services
THE STEPS TO EU COMPLIANCE WITH OBELIS
THE STEPS TO EU COMPLIANCE WITH OBELIS
EAR appointment
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You appoint Obelis as your European Authorized Representative
EAR appointment
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You appoint Obelis as your European Authorized Representative
Documentation review
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Obelis reviews your technical documentation (Declaration of Conformity, Labels & IFUs)
Documentation review
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Obelis reviews your technical documentation (Declaration of Conformity, Labels & IFUs)
Device Registration
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Obelis registers your devices in the member states that require additional national registration
Device Registration
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Obelis registers your devices in the member states that require additional national registration
Device Notification
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Obelis notifies your devices to the Competent Authorities in Belgium, you can affix the CE marking
Device Notification
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Obelis notifies your devices to the Competent Authorities in Belgium, you can affix the CE marking
Free Sales Certificate Application
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Obelis applies for a Free Sales Certificate that will give you access to markets outside EU
Free Sales Certificate Application
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Obelis applies for a Free Sales Certificate that will give you access to markets outside EU
Notifying your devices today will make a difference for millions...
Notifying your devices today will make a difference for millions...
Due to the fast spread of COVID-19, Europe is registering increasing shortages of generic IVD devices. Time is of essence and we need to move fast to secure the supply of such products on the European market.
Due to the fast spread of COVID-19, Europe is registering increasing shortages of generic IVD devices. Time is of essence and we need to move fast to secure the supply of such products on the European market.
READY TO GO ON THE EU MARKET?
READY TO GO ON THE EU MARKET?
All Right Reserved 2021 © Obelis Group
All Right Reserved 2021 © Obelis Group
Stay in touch
Stay in touch
Have other products you need to bring to the EU market? Let us know!
Have other products you need to bring to the EU market? Let us know!
How to Enter the EU Market Booklet
How to Enter the EU Market Booklet
An overview of the steps you need to take to become compliant on the EU market
An overview of the steps you need to take to become compliant on the EU market
- List of the steps to EU complaince
- List of the steps to EU complaince
- Non-EU manufacturers must appoint an European Authorized Representative
- Non-EU manufacturers must appoint an European Authorized Representative
- Technical documentation
- Technical documentation
- Notification to the European Competent Authorities
- Notification to the European Competent Authorities
Access to EU market
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You can place your devices on the European market and start selling to millions of EU consumers
Access to EU market
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You can place your devices on the European market and start selling to millions of EU consumers
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