On the 11 February 2015 the MHRA will be introducing the Devices Online Registration System (DORS) which is a new online system for registration of medical devices. The new system will enable manufacturers and/or designated authorised representatives who place and put into service class I medical devices, systems and procedure packs, custom made medical devices, custom made active implantable devices and/or in vitro diagnostic devices on the UK market to submit their registrations to the MHRA electronically.

The link to DORS will be available on the following webpage from the 11 February 2015:

https://aic.mhra.gov.uk/era/drsystem.nsf/login.

To submit a registration via DORS, you will need to create an online account with a secure password beforehand. You may create an online account in two simple steps:

1. On the home page of DORS select ‘Create Account’ from the left hand menu. On being requested to identify the type of organisation that you are, please indicate whether you are a manufacturer, authorised representative or assembler.
2. On the next page you will be requested to input your contact details. Complete as many fields as possible and ensure that all fields that are marked with a red asterisk are correct. Please then read the terms and conditions, tick the box to confirm that you accept these, and click on the submit box.

The MHRA will check your details and email you when the account is activated. You will then be able to log in to DORS and start a new registration.  However, if the MHRA identify an anomaly with the account application, they will contact you for clarification before activating.

If you are already registered with the MHRA, you will only have to create an online account when you make a change to your details or register a new device.

Please note that there has been no change to the requirement to submit to the UK competent authority, for new and subsequent changes to the registered details held, the statutory fee of £70.00.

For any help with the online process the DLA have flowcharts available for members which are step by step guides for the on the Online Registration process. They include information on amending an existing registration.

The MHRA will stop accepting paper registrations on 11 May 2015. After this date you must register online using DORS to submit a registration to the MHRA.  Additionally, any hard copy registrations received up to and including the 11 May 2015 will be processed as per normal until the notification submitted to the Agency has been processed or closed.

For any questions relating to the new online system you can contact the MHRA via email: device.registrations@mhra.gsi.gov.uk  or by phone using the dedicated Fault/Problems phone line 0203 080 6666.

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