Authorized Representation & Importer
Active regulatory presence to protect your regulatory market access
Appointing an Authorised Representative or Importer is not just a regulatory formality. It creates ongoing regulatory obligations, inspection exposure, and shared responsibility.
KAHLITY provides active, accountable Authorised Representative and Importer services, ensuring regulatory requirements are met while protecting the continuity of your market access in Europe, Switzerland, and the UK.
How we work
ASSESS:
We assess your regulatory footprint, product portfolio, target markets, and operational setup to define the appropriate representation and importer model.
DESIGN:
We design a compliant and practical representation structure, aligned with applicable regulations (EU MDR/IVDR, Swiss MedDO/IvDO, UK requirements) and your business strategy.
ACT:
KAHLITY acts as: Swiss Authorised Representative (CH-REP), European Authorised Representative (EU-REP), UK Responsible Person (UKRP) through a trusted UK partner, Importer, where applicable and in combination with Authorised Representation.
INTERACT:
We interface with Competent Authorities and support inspections, audits, and regulatory enquiries related to our representative or importer role.
SUSTAIN:
We maintain ongoing oversight to ensure continued compliance as products, regulations, or organisational structures evolve.
Scope of Services
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Swiss Authorised Representative services
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European Authorised Representative services
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UK Responsible Person services (via trusted partner)
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Importer services provided in combination with Authorised Representation
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Regulatory communication and authority interaction
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Support during audits and inspections
What this enables
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Continued and secure access to Swiss, EU, and UK markets
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Reduced regulatory and liability risk for Legal Manufacturers
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Clear, controlled communication with authorities
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Confidence during inspections and audits
Who we support
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Legal Manufacturers based outside Switzerland, the EU, or the UK
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Organisations seeking reliable, long-term regulatory representation
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Companies expanding or maintaining access to regulated markets
Why KAHLITY
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ISO 13485–certified entities in Switzerland and Europe
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Deep integration with Quality and Regulatory systems
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Active, pragmatic approach to regulatory representation
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Trusted partner network for UK market access
Efficient. Agile. Flexible.
Swiss Authorized Representative
The Mutual Recognition Agreement between Europe and Switzerland ceased to apply. This means Switzerland is a third country. If you are a Legal Manufacturer outside Switzerland, you will have to appoint a Swiss Authorized Representative to continue placing, or start placing your medical devices on the Swiss Market under the revised MedDO or IvDO.
​Who would be interested by this service?
Legal Manufacturers outside Switzerland
European Authorized Representative
If you are a Legal Manufacturer outside Europe, you will have to appoint an European Authorized Representative to continue placing, or start placing your medical devices on the European Market.
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Who would be interested by this service?
Legal Manufacturers outside Europe
UK Authorized Representative
If you are not a manufacturer based in the United Kingdom, you must have a UK Responsible Person (UKRP) to represent you. KAHLITY partners with Compliant Medical Devices in the UK to provide you with the representative you need to place your device on the UK market. Compliant Medical Devices is a medical device consultancy with over twenty years of Notified Body and Competent Authority experience, providing regulatory and quality solutions for medical device companies.
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Who would be interested by this service?
Legal Manufacturers outside the United Kingdom