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Common questions about medical device regulation, market entry, and our services. Can't find what you're looking for? Get in touch.
What is a UK Responsible Person (UKRP) and do I need one?
A UKRP is a mandatory requirement for medical device manufacturers based outside the UK who want to place products on the Great Britain market post-Brexit. The UKRP acts as your legal representative, handling regulatory communications with the MHRA and ensuring ongoing compliance with UK medical device regulations.
What's the difference between EU AR and UKRP services?
EU Authorised Representatives handle regulatory compliance for the European Union market under MDR/IVDR, while UK Responsible Persons manage compliance for the Great Britain market under UKCA regulations. Both serve as your legal representative but operate under different regulatory frameworks and requirements.
How does SMEDTEC OS improve regulatory operations?
SMEDTEC OS is an AI-powered platform that automates regulatory documentation, tracks compliance deadlines, manages audit trails, and provides real-time regulatory intelligence. It reduces manual work by up to 70% and ensures audit-readiness through intelligent document management and automated reporting.
What types of medical devices do you support?
We support all medical device classifications from Class I to Class III under MDR/IVDR, including IVDs, active implantable devices, and combination products. Our expertise covers software as a medical device (SaMD), digital health technologies, and traditional medical devices across therapeutic areas.
How quickly can you help with market entry?
Timeline varies by device classification and target market. For Class I devices, we can typically achieve market entry within 3-6 months. Class II/III devices require 6-18 months depending on complexity and whether clinical data is needed. We provide detailed roadmap assessments during initial consultation.
Do you provide ongoing post-market surveillance support?
Yes, we offer comprehensive post-market surveillance including vigilance reporting, trend analysis, field safety notices, and lifecycle management. Our team monitors regulatory changes and ensures your devices remain compliant throughout their market life.
What's included in UKRP services?
Our UKRP services include MHRA registration, technical documentation review, regulatory compliance monitoring, incident reporting coordination, and annual renewal management. We act as your official representative for all UK regulatory matters.
Can you help with both UK and EU market access?
Absolutely. We provide comprehensive market access services for both UK and EU markets, including dual UKRP/EU AR representation, harmonized documentation strategies, and coordinated regulatory submissions to minimize duplication and accelerate market entry.