We offer

Authorized Representative

You are a producer of a medical device outside the EU or in Switzerland and desire to market the product within the EU as well? Then there is a possibility to do so via an authorized representative. Contact Avanti Europe now and be assured that an expert takes care of your products.

What we offer


on-demand - dedicated expert

The details

- Client owns budget
- Invoiced at a fixed rate
- Working based on product export
- Mid-term assignment

best used for:

As a service, Avanti Europe’s network will act as the Authorized Representative for your medical device(s). The medical devices will have to be marketed in full compliance with the Medical Device Regulation (MDR) 2017/745.

Our network experts will support you in compiling all necessary documentation and data for a successful authorization. As an authorized representative under the MDR, an EC REP will need access to at least the following:

  • EU declaration of conformity
  • EU technical file
  • Reports on conformity assessment according to MDR
  • Certificates
  • Amendments and supplements of documentation
  • EUDAMED registration proof

How it works

Created by potrace 1.10, written by Peter Selinger 2001-2011

The mechanics

tuning to your demand

The details

- Client defines products
- Client defines frequency of information exchange
- Digital data exchange to support EU registration
- Back-traceable reporting

Required Information (as per MDR):

Avanti Europe’s network agent is acting as your Authorized Representative in the EU requires a constant and close exchange of information and documentation for reporting reasons to authorities. A digital solution to access and exchange documentation is the best choice.

An Avanti Europe’s network expert will act as the single point of contact (SPOC) in all belongings towards the client.

The costs

The price tag

optimized cost structure

The cost details

- Depending on process landscape
- Depending on number of products
- Depending on number of outsourced manufacturing steps
- Depending on work-load
- Invoiced as a monthly fixed rate

Cost structure:

Costs are transparently fixed at the beginning of a term. A term can be individually defined or prolonged.

Depending on the volume of documents and number of products, the costs will be representative of the real efforts of maintaining the product on the EU market. Depending on demand, further development, expansion of the market or alike, the authorized representative resource can be easily scaled to the demand.