EUROPEAN AUTHORIZED REPRESENTATIVE

The European Authorized Representative is vital in the CE Marking of medical and in-vitro diagnostic devices under current MDR and IVDR regulation. Based in any non EU countries and if you don’t have one, you won’t sell your goods within the EU. We can help you comprehend the responsibilities that go along with them.

At all times, we promise the most significant degree of professional confidence and civility. This is stated in our regular service contract or, if you desire it, in a specific confidentiality agreement signed with you.

Non-European manufactures will not be contacted directly by EU authorities. Your European Authorized Representative will be the point of contact for all communications involved during registration, import alert, vigilance etc.

Your European Authorized Representative’s name and address must appear on your labelling, packaging, directions for use and, importantly, the technical file. Consequently, when various parties from all across Europe have issues or inquiries about your devices, they will contact us. It means we’ll be in continual contact with your distributors, end-users, consumers, and other stakeholders.

  • Review of Technical Documentation

  • If enforcement action is taken against foreign manufacturer, EU Representative should cooperate with the authorities.

  • Perform any other responsibilities outlined in the written mandate that they and the manufacturer have agreed on.

HOW CAN BE YOUR TRUSTED PARTNER?

Our extensive knowledge of European legislation will aid in a smooth and efficient registration process. We give all our authorized representation customers with recurring and detailed information on crucial European Market regulatory revisions. In addition to our German office, we have offices in India, Malaysia, UK and USA. Regardless of the time zone, we can provide expert assistance to you.

There is a diversified and hard function of a European representative. The major tasks include the following, but are not limited to:

  • Provision of a European Union registered address
  • Keep all technical documents available to the European Competent Authorities for examination
  • European Authorities Completing Notifications
  • Completion of all national database registrations
  • Collect, review and reporting of incidents
  • On behalf of the manufacturer, authorities and notified bodies representing the European Commission
  • Ensure continuously updated regulatory compliance and protection
  • Transfer of updated regulatory information on time to customers.

EU Registration and or EUDAMED Registration for the smooth transfer of goods via European Port of Entry

Our educated and experienced advisors will review your Technical File, assist you in registering a medical device or IVD if necessary, and respond to any questions or concerns raised by the Competent Authorities.

We coordinate with Notified Body of your choice once the project is allocated to us.

BEST PRICE OFFER

No falls promises and no extra billing. Our annual Fees are fixed.

  • 24X7 Chat support

  • 6 days working and processing files

  • Economic pricing and polite staff

650 Euros/ year. Additional Devices 100 Euros

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque vitae massa et augue pharetra facilisis. Ut ac lacinia dolor. Praesent sed leo et dui rhoncus finibus vel pulvinar nisl.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque vitae massa et augue pharetra facilisis. Ut ac lacinia dolor. Praesent sed leo et dui rhoncus finibus vel pulvinar nisl.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque vitae massa et augue pharetra facilisis. Ut ac lacinia dolor. Praesent sed leo et dui rhoncus finibus vel pulvinar nisl.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque vitae massa et augue pharetra facilisis. Ut ac lacinia dolor. Praesent sed leo et dui rhoncus finibus vel pulvinar nisl.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque vitae massa et augue pharetra facilisis. Ut ac lacinia dolor. Praesent sed leo et dui rhoncus finibus vel pulvinar nisl.

UDI-DI NUMBER

The UDI is a series of numeric or alphanumeric characters created by device identification and coding standards. It enables a well defined medical item to be identified on the market. The UDI system will facilitate medical device tracking, enhance the efficiency of safety-related actions on devices in the post-market environment and enable relevant authorities to monitor them better. It also helps to reduce medical mistakes and to combat fraudulent medical equipment. To identify a medical equipment, a UDI code is utilised.

EUDAMED REGISTARTION

The EUDAMED module for SRN registrations was launched by the European Commission on 1 December 2020. This module is used for EUDAMED registration and receipt by producers, authorised representatives, importers and system and process pack makers. In order to obtain your SRN as quickly as possible we encourage early registration.

CONTACT US

Choose File
Thank you for your message. It has been sent.
There was an error trying to send your message. Please try again later.