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About
**Who they are** Saverine (Authorised Representative) is a dedicated provider of EU Authorized Representative services. They focus on ensuring that non-EU manufacturers comply with European Union regulations for medical devices and other regulated products.
**Expertise & scope** * Facilitating market access for non-EU manufacturers into the European Union. * Acting as the official point of contact for EU regulatory authorities. * Ensuring compliance with relevant EU directives and regulations. * Providing representation services for the UK market alongside EU coverage.
**Reputation / proof points** * Coverage extends to both the EU and the UK.
Additional information
When engaging Saverine (Authorised Representative), it is important to note their specific coverage areas. While they offer comprehensive EU representation, their services also explicitly include the UK market. This dual coverage can be particularly beneficial for manufacturers targeting both regions. Buyers should be prepared to provide detailed product information and technical documentation to facilitate the compliance process. Understanding the specific regulatory requirements for your product class within the EU and UK is essential for a smooth engagement.
Key Highlights
Provides EU Authorized Representative services.
Source
“Saverine (Authorised Representative) is a dedicated provider of EU Authorized Representative services.”
Offers representation services for the UK market.
Source
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 UK Authorized Representative
How engagement typically works
Direct representation for regulatory authorities
Facilitation of market compliance
Typical deliverables
Designated EU Authorized Representative
Designated UK Representative
Good to know
Best when the manufacturer is based outside the EU and UK
HQ: Manchester, US
Languages: English
Timezones: Europe/London
Claim 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.