Medical Devices
Medical device manufacturers in Europe seeking to enter the San Marino market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Institute for Social Security oversees medical device regulation in San Marino, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.
Taylored Consultancy provides complete medical device regulatory support for Europe companies expanding to San Marino. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.
Comprehensive risk classification under San Marino medical device regulations, conformity assessment pathway determination, and regulatory strategy development.
Complete registration process with Institute for Social Security, including dossier preparation, technical documentation, submission management, and authority liaison for approval.
We act as your authorized representative in San Marino, handling regulatory communications, maintaining compliance documentation, and managing authority interactions.
Complete technical file preparation including device description, design verification, risk management, clinical evaluation, and manufacturing documentation for San Marino.
ISO 13485 quality management system verification, manufacturing evidence compilation, GMP compliance documentation, and quality assurance systems for San Marino approval.
Conformity certificates, import licenses, market authorization applications, and ongoing post-market surveillance requirements for successful San Marino market entry.
