AFINA services
EU representation and regulatory support
Direct specialist services for manufacturers entering or operating in the European market. Choose the legal role or regulatory task that matches your situation.
Representation in the EU
Legal representative and responsible-person roles for non-EU manufacturers and providers. Each service follows a different regulation and mandate.
EU Authorised Representative & PRRC
EU Authorised Representative under MDR/IVDR Article 11 and PRRC services for medical-device and IVD manufacturers established outside the EU.
MDRIVDRPRRC View getEAR services →GPSR Responsible Person
EU Responsible Person services under Regulation (EU) 2023/988 for manufacturers and online sellers established outside the European Union.
GPSRConsumer productsOnline sellers View getGPSR services →Cosmetics Responsible Person
EU Responsible Person services under Regulation (EC) No 1223/2009 for cosmetics manufacturers and brand owners established outside the EU.
CosmeticsCPNPProduct information View cosmetics RP services →REACH Only Representative
Article 8 Only Representative services for non-EU substance manufacturers, allowing EU importers to rely on the representative's REACH registration.
REACHArticle 8Registration support View REACH OR services →AI Act Authorised Representative
Mandated EU point of contact for non-EU providers of high-risk AI systems under Article 22 of the EU AI Act.
AI ActArticle 22High-risk AI View AI representative services →Consulting and decisions
Support for defining the route, preparing evidence and documentation, and deciding whether an EU market entry is commercially and regulatorily realistic.
MDR & IVDR compliance support
Strategy, classification, evidence planning and technical-documentation readiness for medical-device and IVD manufacturers.
MDRIVDRTechnical fileEUDAMED View MDR/IVDR services →CE marking & EU certification support
Conformity-assessment planning, technical-documentation support and EU market-access preparation for manufacturers and distributors.
CE markingDocumentationMarket access View CE marking services →Regulatory Gate
Expert-reviewed EU market-entry assessment covering the regulatory route, budget range, timeline, critical risks and a clear go, revise or stop decision.
Gate SnapshotCost & timelineGo / no-go Open Regulatory Gate →Decide Smaller
A free AI tool for high-stakes choices: answer three questions that could change your mind, then get the smallest reversible test before you commit.
BusinessCareerWork & lifeReversible test Test a decision — free →ECP identifies independent testing, certification and notified-body options. The services on this page are operated separately by AFINA s.r.o.; each linked site explains its own scope, process and commercial terms.