Saverine (Authorised Representative)
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About
**Who they are**
Saverine (Authorised Representative) is a specialized service provider focused on EU Authorized Representative functions. They aim to facilitate market access for manufacturers by ensuring compliance with relevant EU regulations.
**Expertise & scope**
* Acts as the EU Authorized Representative for non-EU manufacturers.
* Ensures compliance with EU directives and regulations.
* Facilitates communication between manufacturers and EU authorities.
* Manages necessary documentation and registration processes.
**Reputation / proof points**
* Coverage extends to both the EU and the UK.
Saverine (Authorised Representative) is a specialized service provider focused on EU Authorized Representative functions. They aim to facilitate market access for manufacturers by ensuring compliance with relevant EU regulations.
**Expertise & scope**
* Acts as the EU Authorized Representative for non-EU manufacturers.
* Ensures compliance with EU directives and regulations.
* Facilitates communication between manufacturers and EU authorities.
* Manages necessary documentation and registration processes.
**Reputation / proof points**
* Coverage extends to both the EU and the UK.
Additional information
Saverine (Authorised Representative) focuses on the critical role of an EU Authorized Representative. This involves understanding the specific regulatory landscape for medical devices and other regulated products within the European Union. Their service is designed to bridge the gap for manufacturers located outside the EU, providing a local point of contact and ensuring adherence to all applicable legal requirements for placing products on the EU market. Engagement typically involves a thorough review of the manufacturer's product and compliance documentation to establish the necessary framework for representation.
Key Highlights
Certifications & Trust Signals
-
Established presence as an Authorised Representative.
Source
“Saverine (Authorised Representative) is a specialised service provider that acts as your EU Authorised Representative.”
Buyer Snapshot
Best for
- Non-EU manufacturers seeking EU market access.
- Companies requiring a dedicated EU Authorized Representative.
How engagement typically works
- Formal appointment as EU Authorized Representative.
- Ongoing compliance support and communication.
Typical deliverables
- Designated EU Authorized Representative.
- Facilitation of regulatory compliance.
- Liaison with EU competent authorities.
Good to know
- Best when the manufacturer has products intended for the EU market.
HQ:
Manchester, US
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK
Countries:
IE, GB, DE, FR
Industries:
Medical devices, IVD, Healthcare
Portfolio:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 2,500
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Post Market Support:
Yes
Labeling Review:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Additional eu_ar Details
Supports MDR
true
Supports IVDR
true
Fsca Recall Support
true
Post Market Support
true
Vigilance Contact Support
true
Onboarding Steps
Requires manufacturer's quality management system details, product technical documentation, and intended use information. Process designed to ensure accurate representation and compliance.
