IVD
Bringing an IVD to the EU market means meeting Regulation (EU) 2017/746 (IVDR) - a major step up from the old directive, with a risk-based Class A to D system, far greater Notified Body involvement, and phased transition deadlines running to 2029.
At Taylored Consultancy Ltd, we make IVD compliance clear and stress-free. From classification and performance evaluation to your technical documentation and CE marking, we help you meet IVDR requirements and hit the transition timelines without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, and ready for market.
We determine the correct class (A, B, C or D) under IVDR, which drives your conformity assessment route and Notified Body involvement.
With phased deadlines through 2027-2029 (conditional on having an IVDR-compliant QMS in place), we help you plan and stay on track.
We help you compile scientific validity, analytical and clinical performance evidence, and your Performance Evaluation Report.
We build your risk management file to the recognised standard.
We help you build IVDR-compliant technical documentation that stands up to Notified Body scrutiny.
We review your labelling and instructions for use (ISO 18113), including UDI and EUDAMED requirements.
Non-EU manufacturers need an EU Authorised Representative and EUDAMED registration. We act as your EC REP and handle registration.
We help you implement an IVDR-ready QMS to ISO 13485 - required to benefit from the transition timelines.
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
