Medical Devices
Medical device manufacturers in Europe seeking to enter the United Kingdom market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Medicines and Healthcare products Regulatory Agency (MHRA) oversees medical device regulation in United Kingdom, 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 United Kingdom. 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.
Conformity with UK Medical Devices Regulations 2002 (as amended), classification assessment, and technical file preparation for UK market authorization and MHRA approval.
Risk class determination (Class I, IIa, IIb, III) under UK rules, conformity assessment route selection, and regulatory pathway planning for UK market entry.
We act as your mandatory UK Responsible Person (UKRP), handling MHRA notifications, maintaining technical documentation, and serving as your regulatory contact point.
Comprehensive technical file including design documentation, risk management records, clinical evaluation reports, manufacturing information, and quality management systems.
UK Conformity Assessed (UKCA) marking process, MHRA device registration, manufacturer establishment registration, and ongoing compliance with UK post-market requirements.
ISO 13485 quality management system compliance, clinical evaluation preparation, post-market clinical follow-up (PMCF) planning, and UK-specific vigilance requirements.
