IVD
Bringing an IVD to the GB market means working under the UK Medical Devices Regulations 2002 (as amended), overseen by the MHRA, with UKCA marking and a UK Responsible Person for non-UK manufacturers. Reform is underway to move the UK toward a risk-based A to D classification system.
At Taylored Consultancy Ltd, we make IVD compliance clear and stress-free. From classification and performance evaluation to labelling and registration, we help you meet UK requirements and stay ahead of the changing framework.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, and ready for market.
We determine the correct classification for your IVD under current UK rules and the incoming risk-based framework, so you follow the right pathway.
We help you compile scientific validity, analytical and clinical performance evidence to demonstrate your IVD works as intended.
We build your risk management file to the recognised standard.
We review your labelling and instructions for use against UK requirements (ISO 18113) to ensure all mandatory information is correct.
We conduct a full regulatory gap analysis to identify any missing or incomplete documentation.
We handle registration of your IVD with the MHRA before it enters the market.
Non-UK manufacturers need a UK Responsible Person. We act as your RP, keeping your device compliant.
We help you implement a QMS to ISO 13485, the backbone of IVD compliance.
We help you evidence usability and human-factors work to show your IVD is safe to use.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 13485 - Medical devices QMS
ISO 14971 - Risk management for medical devices
ISO 15189 - Medical laboratories quality and competence
ISO 15197 - Blood glucose monitoring systems
ISO 18113 - IVD labelling and instructions for use
ISO 23640 - Stability evaluation of IVD reagents
CLSI guidelines - Laboratory method validation
IEC 61326 - EMC requirements for laboratory equipment
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
