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
Not immediately. Under current transitional arrangements, CE-marked IVDs can still be placed on the GB market, but UKCA marking is the UK's own conformity route and manufacturers should plan for it as MHRA rolls out its reform. We help clients build a marking strategy that works under both regimes, so you're not caught out when transitional recognition ends.
If you're a manufacturer based outside the UK, you need a UK Responsible Person (UK RP) to register your IVD with the MHRA and act as your legal presence in Great Britain. The UK RP takes on specific regulatory responsibilities, including holding technical documentation. We act as UK RP for a number of overseas IVD manufacturers, so you don't need a UK entity of your own.
Yes, the UK is reforming the UK MDR 2002 toward a risk-based A to D classification model, broadly similar in shape to the EU's IVDR, replacing the current self-certification-heavy approach for most IVDs. This will change how much evidence and third-party oversight your device needs, so it's worth planning ahead rather than waiting for the change to land.
MHRA registration typically requires your device classification, technical documentation, a declaration of conformity, and details of your UK Responsible Person if you manufacture outside the UK. Getting this right first time matters, since incomplete submissions get bounced back and cost you weeks. We handle registration end-to-end so your device gets onto the GB market without unnecessary back-and-forth.
In most cases, yes. A QMS aligned to ISO 13485 is expected as the backbone of compliance for placing an IVD on the GB market, and it underpins your technical documentation and post-market obligations too. Even simpler IVDs benefit from a right-sized QMS built in from the start, rather than a bare-minimum one bolted on at the last minute.
The UK currently runs on the Medical Devices Regulations 2002 (as amended), closer in spirit to the old EU IVDD, so most IVDs can self-certify without third-party involvement, unlike the EU's newer, stricter IVDR. That's changing under UK reform, so devices that self-certify today may need more rigorous evidence and independent review in future.
It's usually a straightforward administrative handover rather than a regulatory hurdle. Your new UK Responsible Person takes on your existing MHRA registration and technical documentation, confirms nothing about the device has changed, and updates the RP details attached to your registration. We manage that transition directly with your outgoing provider, so there's no gap in your compliance cover while the switch takes place.
A UK Responsible Person is legally accountable for an IVD's compliance in Great Britain, which covers holding and maintaining technical documentation, registering the device with the MHRA, handling vigilance reporting for any incidents, and acting as the point of contact for the MHRA if a question arises. It's an ongoing legal responsibility for as long as the device is on the market, not a one-off registration task.
Yes, we review IVD advertising and marketing against the UK Advertising Standards Authority's CAP Code, covering claims wording and the evidence you'd need to defend an ad if it were challenged, which matters particularly for direct-to-consumer and self-test products. This sits alongside, not instead of, your wider regulatory claims obligations, so we review both together rather than treating advertising as a separate compliance track.
Still have questions? Contact us and we'll be happy to help.
