# Medical devices: how to comply with legal requirements in Great Britain

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/96ff1b5d-68b1-4d70-bcef-d21245d1432c
Type: Detailed Guide
Published: August 15, 2013
Updated: January 15, 2025

> This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory regulatory framework for medical devices in Great Britain under the Medical Devices Regulations 2002 (UK MDR 2002) and the Consumer Protection Act 1987. The guidance applies to all manufacturers intending to market general medical devices, active implantable devices, or in vitro diagnostic (IVD) products. Devices are classified by risk level, ranging from Class I (low risk) to Class III (high risk). Key requirements for compliance include mandatory registration of all devices with the MHRA and the completion of conformity assessments. For moderate to high-risk devices, manufacturers must involve a UK Approved Body to evaluate clinical data and quality management systems before applying the UKCA mark. Manufacturers are also required to maintain robust clinical evidence and provide notification of clinical investigations at least 60 days in advance. Furthermore, the guidance emphasizes the importance of post-market surveillance and reporting serious adverse incidents. Notably, new legislation to strengthen these surveillance requirements will take effect on June 16, 2025, aimed at improving incident traceability and risk management. Required actions for manufacturers include determining correct device classification, ensuring conformity through approved bodies where necessary, and adhering to strict reporting and registration timelines to ensure products are acceptably safe for their intended purpose.

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## Content

Overview This guidance is specific to the provisions in Great Britain (England, Wales and Scotland). For information on how to comply with the legal requirements in Northern Ireland, read our guidance on the regulations in Northern Ireland . Definition of a medical device You need to decide if your product is a medical device before you go through the compliance process. The Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) defines a medical device is as being used in the: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap investigation, replacement or modification of the anatomy or of a physiological process, or control of conception You can find out more about medical devices in our guidance on borderline products if you are unsure whether your product is a medicine or a medical device or if it overlaps. Medical device types and their associated Part The 3 main types of medical devices and their associated Part in the UK MDR 2002 are: general medical devices: Part II of the UK MDR 2002 active implantable medical devices: Part III of the UK MDR 2002 in vitro diagnostic medical devices ( IVDs ): Part IV of the UK MDR 2002 You must meet the requirements in the relevant Part before your device can be placed in the market. Active implantable medical devices These types of devices are powered implants or partial implants that are left in the human body. Examples of active implantable medical devices include: implantable cardiac pacemakers implantable defibrillators leads, electrodes, adaptors for the above implantable nerve stimulators bladder stimulators sphincter stimulators diaphragm stimulators cochlear implants implantable active drug administration device catheters, sensors for item above implantable active monitoring devices programmers, software, transmitters Active implantable devices are risk classified separately to general medical devices. Specific requirements for these devices are available in Part III of the UK MDR 2002. In vitro diagnostic devices This type of medical device is usually a: reagent reagent product calibrator control material, kit, instrument, apparatus equipment or system intended for use in vitro to examine specimens including blood and tissue donations from the human body Other examples of in vitro devices are blood grouping reagents, pregnancy test kits and Hepatitis B test kits. You can read further guidance on the legislation relating to in vitro diagnostic devices for further information. All manufacturers of IVDs must register their medical device with the MHRA . General medical devices These types of devices usually relate to most other medical devices such as: first aid bandages hip prostheses X-ray equipment ECG monitors heart valves dental materials spectacles depressors Complying with the legal requirements If you are manufacturing a medical device, you must follow these guidelines alongside the relevant Part of the UK MDR 2002. These regulations fall under the Consumer Protection Act 1987 and ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose. The route is different for custom made devices. You can read our guidance on custom made devices for more information. Classification of medical devices Medical devices are given a classification depending on the level of risk associated with them, for example the strictest control is for products with the highest risk. General medical devices and active implantable devices When you have established your product is a general medical device, you need to decide which class your device falls under. The categories are: Class I - generally regarded as low risk Class IIa - generally regarded as medium risk Class IIb - generally regarded as medium risk Class III - generally regarded as high risk How a medical device is classified will depend on factors including the intended purpose of the device, how long it’s intended to be in use for and if the device: is invasive or surgically invasive is implantable or active contains a substance, which in its own right is considered to be a medicinal substance Accessories to medical devices are classified separately to the device, excluding accessories to active implantable devices. You can find out more in our guidance on how to establish which classification your product falls under . Active implantable devices are considered a separate risk class to general medical devices. Specific requirements for these devices are available in Part III of the UK MDR 2002. In vitro diagnostic medical devices ( IVDs ) In vitro diagnostic medical devices are categorised differently into 4 main groups, which are devices: considered as general IVD medical devices within the classifications stated in Part IV of the UK MDR 2002, Annex II List A (as modified by Part III of Schedule 2A to the UK MDR 2002) within the classifications stated in Part IV of the UK MDR 2002, Annex II List B (as modified by Part III of Schedule 2A to the UK MDR 2002) for ‘self-test’ intended to be used by a person at home Conformity assessment and UKCA marking Once you have established how your device should be classified or categorised, you will need to follow the conformity assessment route to show that it has met the requirements in the UK MDR 2002. For more information on marking of medical devices, see our guidance on how medical devices are regulated . Assessment route for general medical devices and active implantable devices If you have decided that your medical device falls into Class II, IIb or III, or is a Class I device that is sterile or has a measurement function, you need to contact a UK approved body that can carry out a conformity assessment for the specific classification. A UK approved body ensures manufacturers comply with the regulations including reviewing clinical and scientific data, manufacturing processes and the quality management system. If they comply the UK approved body will issue a UKCA certificate, which manufacturers can place on their device to show that it has passed the conformity assessment. See more information on the role of a UK approved body and the list of UK approved bodies in Great Britain . The conformity assessment route is different for devices being placed on the market in Northern Ireland. For more information, see our guidance on regulating medical devices in the UK . Class I medical devices do not need to go through a conformity assessment with a UK approved body if they are non-sterile and don’t have a measuring function as they are generally low risk. You must register all medical devices on the Great Britain market with the MHRA . Assessment route for IVDs You must register all IVDs with the MHRA . If your product is listed in Part IV of the UK MDR 2002, Annex II (as modified by Part III of Schedule 2A to the UK MDR 2002) or is a self-test device, you will need to contact a UK approved body. UK approved bodies will need to release in vitro products with the highest risk on a batch-by-batch basis. They will need to ensure that the product meets the relevant requirements before certifying it. You can then place the UKCA mark on your product to demonstrate compliance and it will be ready to place in the Great Britain market. See the different routes to conformity for IVDs in our guidance In vitro diagnostic medical devices: guidance on legislation . The conformity route is different for devices manufactured in healthcare establishments, see the guidance on in-house manufacturer of devices for more information. The conformity assessment route is different for devices being placed on the market in Northern Ireland. For more information, see our guidance on regulating medical devices in the UK](https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#NI). Clinical data and clinical investigations Manufacturers must hold clinical data to support claims made for all types of medical devices. This may be based on clinical investigations and in some cases published literature, where you can demonstrate equivalence. See more information on clinical evaluations . You must inform the MHRA if you are planning to conduct a clinical investigation at least 60 days before starting your investigation. This does not currently apply to IVDs , although you must notify the MHRA about IVDs for performance evaluations. Post-market monitoring and surveillance Once a medical device has been placed on the Great Britain market, the manufacturer is responsible for monitoring the product and reporting serious adverse incidents to the MHRA . See guidance on post-market surveillance for information on how to do this. This ensures the device is acceptably safe to use for as long as it is in use. In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. These measures will come into force on 16 June 2025 and will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues reducing harm. Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices. Find out how to report a non-compliant medical device if you notice any issue with a medical device placed on the Great Britain market.