Is your MHRA information up to date?
By DTA | 2nd February 2022 | News
Make sure you check your MHRA information is up to date. In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority responsible for the MDR.
If you manufacture custom-made dental appliances such as fixed bridges, bleaching trays, crowns, splints, retainers, you are required by the Medical Devices Regulations (MDR) to register with the Medicines and Healthcare Products Regulatory Agency (MHRA), and provide your business address and a description of the devices you produce.
You should review your registration frequently to make sure it is up to date. It is a legal requirement to inform MHRA of any changes to your registration as and when they occur. Please do not wait for reminder emails.
Your registration with the MHRA must be renewed one year after the anniversary date and every two years subsequently. The anniversary date is determined by the date your account was created with the MHRA. If your account was created before 01 January 2021 the first review and renewal reminder date has been set for 01 January 2022. You will receive email reminders from MHRA 3, 2 and 1 month before your renewal date. You will not need to add devices you have already registered again and there is no fee to complete the renew application. The renew registration process is a reminder to review your registration and confirm that it is up to date. Failure to renew your registration will result in your account being suspended. A suspended account means you will not lawfully be able to place devices on the market given it is a legal requirement to hold an active registration with the competent authority (MHRA). It is an offence to place a non-compliant device on the market in the UK.