Under the Medical Device Regulation, these Authorized Representatives shall be qualified/professional and possess the necessary expertise of the regulatory requirements for medical devices in the EU.

More specifically, your Authorized Representatives should have specifically identified a Person Responsible for Regulatory Compliance (PRRC) that shall be  permanently and continuously available within their organization. A distributor, importer or EU Address without a qualified professional will no longer do.

Under the Medical Device Regulation, these Authorized Representatives shall be qualified/professional and possess the necessary expertise of the regulatory requirements for medical devices in the EU.

More specifically, your Authorized Representatives should have specifically identified a Person Responsible for Regulatory Compliance (PRRC) that shall be  permanently and continuously available within their organization. A distributor, importer or EU Address without a qualified professional will no longer do.

Verify EUDAMED registrations

Verify EUDAMED registrations

The scope of medical devices has been widened to include aesthetic purpose.

The scope of medical devices has been widened to include aesthetic purpose.

Provide a Vigilance contact point

Provide a Vigilance contact point

Continuously ensure MDR/IVDR compliance

Continuously ensure MDR/IVDR compliance

Review and keep available your MDR/IVDR Technical Documentation and CE Certification

Review and keep available your MDR/IVDR Technical Documentation and CE Certification

Enroll Person Responsible for Regulatory Compliance

Enroll Person Responsible for Regulatory Compliance

All Right Reserved 2021 © Obelis Group

All Right Reserved 2021 © Obelis Group

Stay in touch

Stay in touch

Need assistance with other products? Get in touch!

Need assistance with other products? Get in touch!

As your European Authorized Representatives, Obelis will:

As your European Authorized Representatives, Obelis will:

Why should you choose Obelis?

Why should you choose Obelis?

Creating compliance for safer markets is in our roots. 

At Obelis, we are helping more than 3,000 companies over 70 countries to sell their products on the European market. 

Creating compliance for safer markets is in our roots. 

At Obelis, we are helping more than 3,000 companies over 70 countries 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 13485 Certified

We are ISO 13485 Certified

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

Member of European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets across the world. 

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

Member of European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets across the world. 

You might also be interested in:

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We register your Medical Devices and IVDs in Europe in 

6 working days! 

We register your Medical Devices and IVDs in Europe in 

6 working days! 

EUROPEAN AUTHORIZED

                             REPRESENTATIVE

EUROPEAN AUTHORIZED

                             REPRESENTATIVE

Devices

Devices

Manufacturers

Manufacturers

CE Marking

CE Marking

CE marking shall be affixed on devices complying with the MDR.  Devices will freely circulate in the European Economic Area and Switzerland provided that the manufacturer will continue complying with their obligations under the MDR and that the devices are safe.

CE marking shall be affixed on devices complying with the MDR.  Devices will freely circulate in the European Economic Area and Switzerland provided that the manufacturer will continue complying with their obligations under the MDR and that the devices are safe.

Manufacturers shall establish, implement, document and maintain a risk management system, and eliminate or reduce risks as far as possible through safe design and manufacture. 

They shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with the Regulation in the most effective manner and in a manner which is proportional  to the risk class and the type of device.

Manufacturers shall establish, implement, document and maintain a risk management system, and eliminate or reduce risks as far as possible through safe design and manufacture. 

They shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with the Regulation in the most effective manner and in a manner which is proportional  to the risk class and the type of device.

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. 

They shall be safe and effective and shall not compromise the clinical condition or the safety of patients.

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. 

They shall be safe and effective and shall not compromise the clinical condition or the safety of patients.

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