We offer

Authorized Representative

You are a producer of a medical device outside the EU 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

Avanti Europe is your EC REP in Switzerland

Your EC REP

on-demand - dedicated expert

The details

- Client owns budget
- Invoiced monthly at a fixed rate
- Working against task order
- On-site availability of expert
- Mid-term assignment

best used for:

As a service, Avanti Europe 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 experts will support you in compiling all necessary documentation and data for a successful authorization. As a authorized representative under the MDR, Avanti Europe 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

How Avanti Europe operates

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 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 expert will act as the single point of contact (SPOC) in all belongings towards the client.

The costs

Costs involved with consultancy

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.