UK MHRA: New Devices Online Registration System (DORS) to go live
The new Medicines and Healthcare products Regulatory Agency (MHRA) Devices Online Registration System (DORS) will be live on 11 February 2015.
You will be able to register the following devices online and manage your details directly:
- class I medical devices
- systems and procedure packs
- custom made medical devices
- custom made active implantable devices
- in vitro diagnostic devices online and manage your details directly.
The link to DORS will be available on 11 February 2015.
The first step will be to create an online account.
You can create an online account in 2 simple steps.
On the home page of DORS you should select ‘create account’ from the left hand menu. When you are asked to identify the type of organisation that you are, you should indicate whether you are a manufacturer, authorised representative or assembler.
On the next page you will be asked to input your contact details. You should complete as many fields as possible and ensure that all fields that are marked with a red asterisk are correct. Then read the terms and conditions, tick the box to confirm that you accept these, and click on the submit box.
We will check your details and email you when the account is activated. You can then register your organisation and the related devices.
As before, there is a fee of £70.00 for new registrations and for making certain changes.
If you are already registered with us, you will only have to create an online account when you make a change to your details or register a new device.
MHRA will stop accepting paper registrations on 11 May 2015. After this date you must register online using DORS.
If you encounter any problems or need more information you should email email@example.com or call 020 3080 6666.
You should provide:
- the action that you were trying to achieve
- the route taken using the system and/or the toggles you activated
If you are submitting your fault report by email, you should also provide any screen views showing any error or fault warnings.
Posted on the UK MHRA website on 30 January 2015