UKRP Medical Device
UKRP medical device support
Authority for Medical Device Registration
In order to place their medical devices on the market in Great Britain, manufacturers are required to register their devices with the Medicines and Healthcare products Regulatory Agency (MHRA).
Definition of Medical Device
A "medical device" refers to an instrument, apparatus, appliance, material, or any other article, whether used alone or in combination, including any necessary software for its proper application, which meets the following criteria:
(a) It is intended by the manufacturer to be used for the purpose of:
(i) diagnosing, preventing, monitoring, treating, or alleviating disease;
(ii) diagnosing, monitoring, treating, alleviating, or compensating for an injury or handicap;
(iii) investigating, replacing, or modifying the anatomy or a physiological process; or
(iv) controlling conception.
(b) It does not achieve its primary intended action in or on the human body through pharmacological, immunological, or metabolic means, even if it is assisted by such means. This definition also includes devices intended to administer a medicinal product or those that incorporate a substance, which, if used separately, would be a medicinal product and can act upon the body with ancillary action to that of the device.
An "in vitro diagnostic medical device" refers to a medical device that:
(a) Is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination; and
(b) Is intended by the manufacturer to be used in vitro for examining specimens, including blood and tissue donations from the human body, primarily for the purpose of providing information related to:
(i) physiological or pathological state;
(ii) congenital abnormality;
(iii) safety and compatibility of donations, including blood and tissue donations, with potential recipients; or
(iv) monitoring therapeutic measures. This definition excludes general laboratory products unless specifically intended for in vitro diagnostic examination based on their characteristics.
Medical Device Classification
Devices are classified into Class I, IIa, IIb, or III, following the classification criteria outlined in Annex IX of Directive 93/42.
Medical Device Registration Pathways
Prior to registration, devices must obtain either CE marking or UKCA marking.
For manufacturers located outside the UK, their appointed UK Responsible Person (UKRP) must register the devices on their behalf.
It's important to note that the registration process serves as a notification and does not validate the safety or efficacy of the device. The registration confirmation letter and guidance from the MHRA explicitly state that registration does not constitute approval or certification of the device.
The registration process involves providing the following information (non-exhaustive list):
Proof of UKRP appointment (for non-UK manufacturers), such as a Letter of Designation or Agreement
Manufacturer's legal name and address
Applicable regulation, such as the Medical Devices Directive 93/42/EEC
Indication of whether the device is sterile, and if so, the method of sterilization
Information on whether the device is implantable, active, single-use, etc.
Copy of relevant verification of conformity assessment, such as a CE marking Certificate or Declaration of Conformity
Device name, model(s), and catalogue numbers
Indication of the UK countries where the device will be placed
AF Pharma, a recognized organization in medical device services, can provide assistance by acting as a UK Responsible Person (UKRP) for medical devices. AF Pharma is well-equipped to support manufacturers located outside the UK in registering their devices with the Medicines and Healthcare products Regulatory Agency (MHRA). By appointing AF Pharma as their UKRP, manufacturers can benefit from their expertise and ensure compliance with the registration requirements in Great Britain. AF Pharma's dedicated team can guide manufacturers through the registration process, offering support in compiling the necessary documentation and fulfilling the registration obligations.
For more information about the services check our UKRP medical device information.