Casus Consulting (Importer/Distributor Requirements)
Casus Consulting
Casus Consulting specializes in guiding businesses through importer and distributor compliance requirements. They offer expertise to ensure smooth operations in regulated markets.
Casus Consulting is a dedicated partner for businesses navigating the complexities of importer and distributor compliance. They provide specialized services to ensure that companies meet all regulatory obligations, facilitating seamless entry and operation within target markets. Their expertise covers a broad range of compliance areas, helping clients avoid pitfalls and maintain operational integrity. Whether your business is importing goods or acting as a distributor, Casus Consulting offers tailored solutions to address your specific needs. They understand the nuances of international trade regulations and domestic compliance laws, offering strategic advice and practical support. Their goal is to empower clients with the knowledge and tools necessary to achieve and maintain compliance, fostering trust and long-term success.
About
**Who they are**
Casus Consulting (Importer/Distributor Requirements) guides businesses through importer and distributor compliance requirements, offering expertise for smooth operations in regulated markets.
**Expertise & scope**
* Assistance with EU Authorized Representative (EU AR) mandates, including ongoing compliance.
* Support for MDR CE Marking and IVDR CE Marking processes.
* Guidance on UK Responsible Person roles, MHRA Device Registration, and UKCA Marking.
* Expertise in navigating importer requirements for the EU market.
**Reputation / proof points**
* Trusted by over 250 medical device & IVD manufacturers across 20 countries.
* Offers fast, responsive support from experienced regulatory professionals.
* Provides direct access to a dedicated regulatory contact.
* Transparent, flat-fee pricing structure.
Casus Consulting (Importer/Distributor Requirements) guides businesses through importer and distributor compliance requirements, offering expertise for smooth operations in regulated markets.
**Expertise & scope**
* Assistance with EU Authorized Representative (EU AR) mandates, including ongoing compliance.
* Support for MDR CE Marking and IVDR CE Marking processes.
* Guidance on UK Responsible Person roles, MHRA Device Registration, and UKCA Marking.
* Expertise in navigating importer requirements for the EU market.
**Reputation / proof points**
* Trusted by over 250 medical device & IVD manufacturers across 20 countries.
* Offers fast, responsive support from experienced regulatory professionals.
* Provides direct access to a dedicated regulatory contact.
* Transparent, flat-fee pricing structure.
Additional information
Casus Consulting emphasizes a practical, business-minded approach to regulatory compliance. For medical devices and IVDs entering the EU market, obtaining CE Marking is a prerequisite. This involves compiling technical documentation and implementing a quality management system. For lower-risk devices, manufacturers can self-certify, while higher-risk products require a conformity assessment review by a Notified Body, which can involve audits and may take 12 months or more. Casus Consulting can assist with specific documentation elements or provide full support throughout this process.
Key Highlights
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Trusted by over 250 medical device & IVD manufacturers across 20 countries.
Source
“Trusted by 250+ medical device & IVD manufacturers across 20 countries”
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Provides complete EU AR representation from initial mandate through ongoing compliance.
Source
“Complete EU AR representation from initial mandate through ongoing compliance”
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Offers transparent, flat-fee pricing for EU AR services with no hidden costs.
Source
“Transparent, flat-fee pricing with no hidden costs”
Certifications & Trust Signals
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Specializes in guiding businesses through importer and distributor compliance requirements.
Source
“Casus Consulting specializes in guiding businesses through importer and distributor compliance requirements.”
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Offers expertise to ensure smooth operations in regulated markets.
Source
“They offer expertise to ensure smooth operations in regulated markets.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU and UK market access.
- Companies needing assistance with regulatory compliance for importer and distributor roles.
- Businesses requiring guidance on CE Marking, MDR, and IVDR.
How engagement typically works
- Direct access to dedicated regulatory contacts.
- Transparent, flat-fee pricing.
- Responsive and experienced professional support.
Typical deliverables
- EU Authorized Representative services.
- MDR/IVDR CE Marking support.
- UK Responsible Person services.
- MHRA Device Registration guidance.
- UKCA Marking assistance.
- Technical documentation and QMS support.
Good to know
- Best when engaging for specific regulatory compliance needs in Europe and the UK.
Pricing
Model:
Per project
HQ:
London, United Kingdom
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU, UK
Countries:
GB, IE, DE, FR, NL, BE
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
1-5, 6-25
Onboarding time:
4–21 days
Pricing model:
Per project
Starting from:
GBP 1,500
Included services:
Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support
Role Coverage:
Both
Additional importer_distributor_compliance Details
Role Coverage
Importer, Distributor, EU Authorized Representative, UK Responsible Person, Authorized Representative, Responsible Person
Device Classes Supported
All device classes supported (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Onboarding Steps
Steps include obtaining CE Marking, appointing an EU Authorized Representative, registering the company and devices, and identifying EU Importers.
