What we offer
Your EC REP
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:
- Start-up's and established companies
- Companies not willing to open a subsidiary in the EU
- Restricted budget
- Medical devices of EU Class I, Is, Im, Ir, IIa, IIb, III
- Bridging gap till opening a subsidiary in the EU
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
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):
- Declaration of conformity per product
- Technical file per product
- Amendments and supplements to documentation
- Change and CAPA log and procedures
- EUDAMED entry proof
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:
- Transparent costs
- Simple billing structure
- Scalable with small price steps
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.