Medical Devices
Bringing a medical device to market means navigating complex regulations, technical requirements, and ongoing compliance obligations.
At Taylored Consultancy Ltd, we cut through the confusion and provide clear, commercially focused regulatory support to help you launch with confidence. Whether you need help with technical documentation, product classification, or quality management systems, we ensure your device meets UK and EU regulations without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your medical devices approved, compliant, and trusted.
Unsure how your product is classified? We determine the correct classification under UK MDR, ensuring you follow the right regulatory pathway.
If your device comes into contact with the body, it needs biocompatibility testing. We help you identify the right testing requirements and ensure results are documented correctly.
A CER is essential for demonstrating safety and performance. We help compile and review clinical data to support compliance with UK MDR.
We assist in generating and reviewing your GSPR to ensure your device meets all safety and performance requirements under the latest regulations.
Already have documentation but unsure if it meets compliance standards? We conduct a full regulatory gap analysis to identify any missing or incomplete requirements.
Medical device regulations can be complex, but they don't have to slow you down. We provide practical, strategic support to help you meet compliance requirements efficiently - so you can focus on getting your device to market.
Your device's labeling must comply with strict UK and EU regulatory requirements. We review your labels to ensure all mandatory information is correct and compliant.
We handle medical device registrations in the UK, ensuring your product is correctly listed before it enters the market.
If you're a non-UK manufacturer, you must appoint a UK Responsible Person (UKRP). We act as your RP, ensuring your device remains compliant and meets all market requirements.
Medical device regulations can be 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.
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ISO 13485 - Medical devices
ISO 9001 - General
EN 62304 - SaMD / software within a medical device
ISO 15378 - Medical packaging
ISO 11135 - Ethylene oxide sterilisation of medical devices
ISO 10993 - Biocompatibility
ISO 14971 - Risk management for medical devices
IEC 60601 - Electrical safety and electromagnetic compatibility for medical devices
ISO 14155 - Clinical investigation conduct
2014/53/EC - Bluetooth
FCC - Federal Communications Commission requirements for Bluetooth/ Wi-Fi
ISO 15197 - Blood glucose monitoring systems
IEC 61326 - EMC requirements for electrical equipment
CLSI guidelines - Experienced support
For most devices sold in Great Britain, UKCA marking is the mark that shows your device meets UK MDR requirements, though CE-marked devices have been able to continue on the market under transitional arrangements. Which route makes sense depends on your device, its classification, and how long the current transition provisions apply to it, so it's worth checking your specific case rather than assuming one marking automatically covers you long-term.
Yes, in many cases. The UK has kept transitional arrangements in place allowing CE-marked devices meeting EU MDR (or the older MDD/AIMDD in limited cases) to be placed on the Great Britain market, alongside UKCA marking. These arrangements have been extended more than once, so the safest approach is to confirm current status for your device class rather than assume it's fixed indefinitely.
A UK Responsible Person is a UK-based entity that a non-UK manufacturer must appoint to register their device with the MHRA and act as their local point of contact for regulatory and safety matters. If you're manufacturing outside the UK and want to sell into Great Britain, you need one in place before you can register. We act as UKRP for manufacturers who don't have a UK presence, taking that admin off your plate.
Yes, any medical device placed on the Great Britain market needs to be registered with the MHRA before sale, whether you're a UK manufacturer registering directly or a non-UK manufacturer registering through a UK Responsible Person. Registration follows classification and confirms who's accountable for the device in the UK, so it typically happens once your technical documentation and quality system are in order.
UK MDR 2002 (as amended) is Great Britain's own medical device regulation, separate from the EU's Regulation 2017/745, even though the two frameworks share a lot of the same underlying logic on classification, quality systems and technical documentation. In practice this means a device compliant with one framework isn't automatically compliant with the other, as each requires its own conformity route, marking and registration.
Devices are classified under UK MDR using risk-based rules similar to the EU system, ranging from low-risk Class I products through to higher-risk Class III and active implantable devices, based on factors like invasiveness, duration of use and whether the device is active. Classification decides whether a UK Approved Body needs to be involved and shapes the rest of your technical file, so it's usually the first thing to nail down on any UK submission.
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 a device'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 medical device 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. 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.
