Are you thinking about selling your medical devices in the United Kingdom? If yes, you'll need to get them registered with the MHRA (Medicines and Healthcare Products Regulatory Agency). Don't worry; we're here to help you through the process! We are MHRA Registration consultants in the UK, and we can assist you with getting your medical devices registered not only in the UK but also worldwide.
Let's learn about the step-by-step guide to obtaining UK MHRA Registration for Medical Devices:
Who Can Register?
- The following can register for MHRA:
- Medical Device Manufacturers or UK Responsible Persons based in the UK.
- Northern Ireland-based Authorized Representatives (for the Northern Ireland market).
- Suppliers and distributors don't need to register.
MHRA Registration for Great Britain Market:
- You must inform the MHRA before selling Class I, IIa, IIb, or III devices, custom-made devices, IVDs (In Vitro Diagnostics), or procedure packs in Great Britain.
- If you are a manufacturer outside the UK, appoint a single UK Responsible Person to take responsibility for your medical devices.
MHRA Registration for Northern Ireland Market:
- Manufacturers outside Northern Ireland or the EU must appoint an EU or Northern Ireland-based Authorized Representative.
- Great Britain manufacturers must appoint an Authorized Representative in the EU or Northern Ireland to sell devices in Northern Ireland.
Information Required for MHRA Registration:
- You need to provide the following details for MHRA registration:
- Manufacturer details: legal entity name, address, company type, administrative contact, and a letter of designation for UK Responsible Persons (if applicable).
- Device details: classification, Global Medical Devices Nomenclature (GMDN®) Code, Basic UDI-DI (if applicable), medical device name, model/version detail, catalogue/reference number, etc.
- Conformity assessment certificates or self-certification declarations (as applicable).
Apply on the Medical Device Online Registration System (DORS):
- Create an account on MHRA DORS to start the registration process.
- Verify and ensure that all information provided is up-to-date and accurate.
Fees of MHRA Registration:
- The statutory fee for each registration application is £240.
- Payments for device registration applications should be made through the DORS system.
Review and Renew MHRA Registration:
- Review your registration frequently to keep it up to date.
- Renew your registration every 2 years.
- If changes are necessary, update your registration accordingly.
Public Register of Manufacturers:
- Once registered, your company details and registered medical devices will be listed on the Public Access Registration Database (PARD).
Contact Us for MHRA Registration:
- For any queries or complaints about the registration process.
- If you have questions about your registration details, Email us with your reference number.
- For assistance in determining whether your products qualify as medical devices or their risk class, email us with specific product details.
- Fill out the contact form.
If you need help with UK MHRA Registration for Medical Devices, don't hesitate to get in touch with Mr. Puneet Sharma. You can call him at 08196980555 or reach out via WhatsApp. We are here to assist you throughout the MHRA Registration process. You can contact us through email, phone, or by filling out a contact form. No matter what, we'll be happy to help you with MHRA Registration!
