Responsibilities of Celegence
as your EU Authorized
Representative (AR)

Manufacturers selling Medical Devices in Europe but located outside of Europe (3rd countries) need to appoint a Europe based Authorized Representative (AR) in order to place a medical device on the EU market as required by the new MDR 2017/745. If you are a manufacturer in a 3rd country, Celegence can act as your Authorized Representative to access and maintain your product on the EU market.

Celegence European Union (EU)
Authorized Representative Services:

  • Registration of your product in the required EU countries
  • Act as an intermediary between you the manufacturer and the relevant Competent Authority

  • We shall have available an up-to-date copy of the Declaration of Conformity and Technical File.
  • Celegence will be identified as the AR on your product’s labelling

  • We will work in collaboration with your team and your distributors to support post Market Surveillance activities such as incident reporting and Field Safety Corrective Action.

How Appointing Celegence as your AR will Benefit your Organization

Appointing a regulatory service provider like Celegence has numerous benefits. As regulatory affairs experts with a vast amount of experience in the EU, we can ensure your organization responds to and adopts any new regulations or regulatory updates.
  • Celegence’s team can ensure your Technical File is up to standard, and register your device while managing interactions with the Competent Authorities.
  • Your team will have access at all times to your regulatory documentation, including the technical files, directives, labelling information, etc.
  • With a wide range of experience with the EU MDR, we can ensure this transition requires minimal effort from your team.
  • Celegence provides a cadence of regulatory updates related to EU regulations to the manufacturer.
  • With a global presence, we can ensure a Celegence team member is always available during your working hours to assist with any day-to-day activities.

Additional Information

Download the latest brochure of our capabilities and services.

DOWNLOAD MED DEVICE BROCHURE
In Vitro MDR Regulation Compliance - Celegence

Contact Us

Reach out today to learn how partnering with Celegence to be your Authorized Representative can provide your business with the required regulatory compliance.

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