When representation is needed: Non‑EU medical device manufacturers generally must appoint an EU Authorised Representative (EU AR).
Typical EU AR obligations (examples):
- Act as an EU contact point and support communication with competent authorities (within the mandate).
- Ensure availability/coordination of documentation that may be requested by authorities.
- Support operational workflow for updates and vigilance-related communication.
Service: EU AR for medical devices · PRRC · EUDAMED
When representation is needed: Non‑EU IVD manufacturers generally must appoint an EU Authorised Representative (EU AR).
Typical EU AR obligations (examples): EU contact point, documentation availability support, and coordination of regulatory communication.
Service: EU AR for IVD / IVDR
When representation is needed: Cosmetics placed on the EU market must have an EU Responsible Person (RP) established in the EU.
Typical RP obligations (examples): keeping the PIF available, ensuring compliance obligations are met, and handling authority communication (within the RP role).
Service: Cosmetics Responsible Person · CPNP
When representation is needed: For certain supply chains, non‑EU manufacturers may appoint a REACH Only Representative (OR) to fulfil relevant REACH obligations.
Typical OR obligations (examples): acting within the OR role for registrations/communications and maintaining required records (scope depends on substances and supply chain model).
Service: REACH Only Representative
CE marking directives (PPE, LVD, EMC, RED, Toys, ATEX, PED, etc.)
When representation is needed: Many CE-marking product acts allow an Authorised Representative for defined tasks. In addition, for many harmonised products sold into the EU from outside the EU (including via distance sales), EU market surveillance rules may require an EU-based economic operator to be identified.
Typical authorised representative / EU operator tasks (examples):
- Keep/coordinate availability of the EU Declaration of Conformity and technical documentation (as applicable).
- Support authority requests and corrective actions coordination with the manufacturer.
- Provide a clear EU contact point for compliance communication.
Scope depends on the specific product act and your sales model.
When EU representation / EU operator matters: for cross-border e-commerce, many product categories require an EU-based economic operator and a clear compliance contact point for market surveillance and platform processes.
Typical obligations (examples):
- Identify the responsible EU-based economic operator for the relevant product act.
- Ensure documentation availability and a workable authority-request workflow.
- Align traceability and product information across listings/labels/IFU/DoC (as applicable).
Service: Marketplace compliance / Online sales (EU)
When EU representation may be needed: for non-EU providers placing AI systems on the EU market, EU law may require appointing an authorised representative in the EU.
Typical obligations (high level):
- EU contact point for competent authorities (within the mandate).
- Support documentation availability/requests (scope depends on your role and AI system category).
- Coordinate compliance communication and change/update workflow.
If AI is used in or with medical devices, MDR/IVDR obligations may also apply in parallel.
Service: EU AI Act support / AI compliance (EU)
When registration/notification is relevant: for household chemical products and mixtures, EU chemical compliance workflows may require structured data packs and portal submissions (scope depends on your role and product composition).
Typical tasks (examples):
- Preparation of a structured data pack (composition/SDS inputs, product identity, variants).
- Consistency checks (labels, SDS, company details, product naming).
- Guidance and coordination of submission steps and version tracking.
Service: ECHA dossier & portal registration (household chemicals)
When national requirements apply: food supplements are regulated as food. Czech requirements include specific labelling elements and rules on certain substances/plants (scope depends on formulation and claims).
Typical tasks (examples):
- Documentation pack preparation for market launch readiness.
- Label text review for Czech-specific mandatory warnings and naming conventions.
- Ingredient/composition checklist and risk flags based on provided inputs.
Service: Food supplements for Czech Republic (full package)
