Register Medical Devices to Place on the Market in the UK

Overview

You must register medical devices before placing them on the UK market. This applies to all medical device types, including in vitro diagnostic devices (IVDs), custom-made devices, and systems or procedure packs. Registration is required before placing on the Great Britain (England, Wales and Scotland) or Northern Ireland market.
Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:1]{index=1}

Who Must Register

You must register if you or your company sells, leases, lends or gifts:

• Class I, IIa, IIb or III devices you have manufactured
• Devices you have refurbished or relabelled under your own name
• Any system or procedure pack containing at least one medical device
• Custom-made devices
• IVDs you have manufactured
• IVDs undergoing performance evaluation
  Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:2]{index=2}

UK Responsible Person (UKRP)

If you are based outside the UK, you must appoint a UK Responsible Person who will act on your behalf to register your devices with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:3]{index=3}

When to Register

For devices to be lawfully placed on the Great Britain market, they must be registered with the MHRA before being placed on the market. Failure to register will mean you cannot lawfully place your device on the UK market.
Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:4]{index=4}

Information Required

When registering, you will need to provide:

• Manufacturer and contact details
• Device details including device class, name, model and GMDN code
• UK Responsible Person designation (if applicable)
• Conformity assessment certificates or self-declaration documents
  Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:5]{index=5}

Device Online Registration System (DORS)

To register, you must create an account on the MHRA Device Online Registration System (DORS). You will not be regarded as registered until MHRA confirms acceptance of your device registration.
Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:6]{index=6}

Fees and Review

A statutory fee applies to each registration application. The MHRA may review registrations and request additional technical documentation to validate conformity to regulatory requirements.
Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:7]{index=7}

Additional Notes

Registration with the MHRA is not an approval or endorsement and you may not claim MHRA endorsement in marketing.
Source: Register medical devices to place on the market - GOV.UK :contentReference[oaicite:8]{index=8}