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.

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Verify EUDAMED registrations

SYNC Projects offers the following services to support medical device manufacturers in Israel to comply with the requirements of the MDR/ ICDR: 

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Provide a Vigilance contact point

Continuously ensure MDR/IVDR compliance

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

Enroll Person Responsible for Regulatory Compliance

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As your European Authorized Representatives, Obelis will:

Why should you choose Obelis & SYNC Projects?

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

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

We are ISO 13485 Certified. 

Obelis represents the largest center for consultancy in Europe

SYNC Projects boosts more than 20 years of business experience

SYNC Projects has nearly 20 years of experience providing regulatory and quality services, assists companies in working with the health authorities as well as with the regulatory and quality aspects, and specializes in developing company-tailored quality and regulatory strategies for a medical device.

We register your Medical Devices and IVDs in Europe in 

6 working days! 

In both cases, SYNC Projects will provide you with a competent consultant who is knowledgeable in the field of medical device, skilled and experienced in quality and regulatory affairs, well acquainted with the regulatory requirements and in case of a PRRC, meets the pre-requisites of the MDR and the IVDR.

As Consultant to the PRRC, we will support the manufacturer PRRC to create an annual plan, which will guide him in carrying out the PRRC tasks. Also, our acquaintance and accrued experience in work processes with the Israeli Ministry of Health, enable us to provide to you professional and efficient registration of medical device. Our professional team is alert at all time and being updated continuously as to any changes in the requirements in an ever-evolving field.

We will gladly assist you with medical device registration and renewal, approval for importing medical devices in Israel, Certificate of Free Sales (CFS).