![]() If the manufacturer is based outside of the UK, they must appoint a single UK Responsible Person to take responsibility for all of their medical devices. Register your device to place on the Great Britain market any system or procedure pack containing at least one medical device.Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name.Class I, IIa, IIb or III devices you have manufactured.You must register if you or your company sells, leases, lends or gifts: ![]() It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain. Placing a device on the Great Britain market The following requirements apply to place your device on the UK market. If you are registering a Coronavirus (COVID-19) test kit with the MHRA please take note of our guidance for industry and manufacturers.Īs part of our data validation and scrutiny of applications to register medical devices and products with the MHRA, we may request further technical documentation from you that demonstrates your products conform to the requirements of the Medical Device Regulations. Therefore, you are not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation. Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA. You must ensure all information registered with the MHRA is accurate and up to date. The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that are based in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market). Registration requirements differ for Northern Ireland. ![]() In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be placed on the market and registered with the MHRA. All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).
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