Obelis Group is a quality driven, service oriented company with over 30 years of experience in regulatory affairs

In supporting brand owners in gaining EU Compliance, we act as professional European Authorized Representative & EU Responsible Person.

As your EU Consultant, Obelis supports your product launch to the European market for the following product categories: 

Obelis Group is a quality driven, service oriented company with over 30 years of experience in regulatory affairs

In supporting brand owners in gaining EU Compliance, we act as professional European Authorized Representative & EU Responsible Person.

As your EU Consultant, Obelis supports your product launch to the European market for the following product categories: 

Medical devices & In-vitro diagnostics

Cosmetic products

Biocides

Food Supplements

And more...

Medical devices & In-vitro diagnostics

Cosmetic products

Biocides

Food Supplements

And more...

Under the Medical Device Regulation, this Authorized Representative must be permanently and continuously available, qualified and possess the necessary expertise of the regulatory requirements for medical devices in the EU.

Under the Medical Device Regulation, this Authorized Representative must be permanently and continuously available, qualified and possess the necessary expertise of the regulatory requirements for medical devices in the EU.

1-year delay will provide you with additional months to finalize your compliance with the MDR, which is a complex and lengthy process! Contact our experts today to receive the needed guidance!

1-year delay will provide you with additional months to finalize your compliance with the MDR, which is a complex and lengthy process! Contact our experts today to receive the needed guidance!

The  postponement of the entering into force of MDR delay to 26 May 2021 has been published on 24.04.2020 with its publication in the Official Journal of the European Union.

The  postponement of the entering into force of MDR delay to 26 May 2021 has been published on 24.04.2020 with its publication in the Official Journal of the European Union.

Your Authorized Representative should have specifically identified a Person Responsible for Regulatory Compliance (PRRC) within their organization. A distributor, importer or EU Address without a qualified professional will no longer do.

Your Authorized Representative should have specifically identified a Person Responsible for Regulatory Compliance (PRRC) within their organization. A distributor, importer or EU Address without a qualified professional will no longer do.

All Right Reserved 2020 © Obelis Group

All Right Reserved 2020 © Obelis Group

Stay in touch

Stay in touch

Interested in webinars? Let us know!

Interested in webinars? Let us know!

Why should you choose Obelis?

Why should you choose Obelis?

Creating compliance for safer markets is in our roots. 

At Obelis, we registered over 15,000 cosmetic products in Europe, helping more than 3,000 companies over 70 countires to sell their products on the European market. 

Creating compliance for safer markets is in our roots. 

At Obelis, we registered over 15,000 cosmetic products in Europe, helping more than 3,000 companies over 70 countires to sell their products on the European market. 

We represent the largest center for consultancy in Europe

We represent the largest center for consultancy in Europe

We have more than 30 years of business experience

We have more than 30 years of business experience

Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups

Our regulatory expertise is provided by professionals 

Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups

Our regulatory expertise is provided by professionals 

We are ISO 9001:2015 & 13485 Certified

We are ISO 9001:2015 & 13485 Certified

Ensuring the highest quality of service for your business in Europe.

Co-founders of the European Responsible Person Association (ERPA) & European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets accross the world. 

Ensuring the highest quality of service for your business in Europe.

Co-founders of the European Responsible Person Association (ERPA) & European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets accross the world. 

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We register your products in Europe in 

8 working days! 

We register your products in Europe in 

8 working days! 

YOUR CONSULTANT ON 

EU REGULATION

YOUR CONSULTANT ON 

EU REGULATION