EU AUTHORISED REPRESENTATIVE
The European Authorised Representative/EC Rep 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.
We promise the most significant degree of professional confidence and civility at all times. This is stated in our regular service contract or, if you desire it, in a specific confidentiality agreement signed with you.
Non-European manufacturers will not be contacted directly by European Authorised Representative. However, your European authorised representative or so-called EU rep will be the point of contact for all communications involved during registration, import alert, vigilance etc.
Your European Authorised Representative name and address must appear on your labelling, packaging, directions for use and, significantly, 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 the foreign manufacturers, the EU authorised 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 authorised representation customers 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.
A European authorised representative has a wide range of responsibilities. The following are extensive duties; however, they are not exhaustive:
- 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. The European Authorised Representative team will support and provide appropriate guidance in EUDAMED registration.
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 are European Authorised Representatives and technical consultants, and we coordinate with Notified Body of your choice once the project is allocated to us.
BEST PRICE OFFER
850 Euros/ year. Additional Devices 100 Euros
950 Euros/ year. Additional Devices 100 Euros
1050 Euros/ year. Additional Devices 100 Euros
1150 Euros/ year. Additional Devices 100 Euros
500 Euros/ GMDN Code / Intended use
Processing Fee: 3000 Euros for unlimited devices
Application Filling and Coordination Fee: 750 Euros per EU Registered device.
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. UDI code is used to identify a medical device.
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, authorized representatives, importers and system and process pack makers. To obtain your SRN as quickly as possible, we encourage early registration.