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

You appoint Obelis as your European Authorized Representative

EAR appointment

You appoint Obelis as your European Authorized Representative

Documentation review

Obelis reviews your technical documentation (Declaration of Conformity, Labels & IFUs)

Documentation review

Obelis reviews your technical documentation (Declaration of Conformity, Labels & IFUs)

Device Registration

Obelis registers your devices in the member states that require additional national registration

Device Registration

Obelis registers your devices in the member states that require additional national registration

Device Notification

Obelis notifies your devices to the Competent Authorities in Belgium, you can affix the CE marking

Device Notification

Obelis notifies your devices to the Competent Authorities in Belgium, you can affix the CE marking

Free Sales Certificate Application

Obelis applies for a Free Sales Certificate that will give you access to markets outside EU

Free Sales Certificate Application

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 2020 © Obelis Group

All Right Reserved 2020 © 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

You can place your devices on the European market and start selling to millions of EU consumers

Access to EU market

You can place your devices on the European market and start selling to millions of EU consumers

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