The Medicines & Healthcare products Regulatory Agency (MHRA) Devices Division has developed and successfully piloted a new online service to manage the Devices Division’s business which:
We want to improve your satisfaction with the services we offer by improving the transparency, responsiveness, usability and effectiveness of our services. By making our systems easier to use, we will not only improve our service to our customers, we will reduce our own administrative burden and give our staff more time to focus on what really matters.
PLEASE NOTE, NO EXISTING REGISTRATIONS WILL BE CANCELLED
ALL Certificates of Free Sale (CFS) AND Device Registration (DR) CUSTOMERS WILL RECEIVE SPECIFIC AND DETAILED INSTRUCTIONS AND SUPPORT TO PREPARE FOR USING THE NEW SYSTEM.
What are we doing and why?
The MHRA Devices Division has designed a new online service to not only better manage our own business, but to put you, our customers, at the heart of our business by designing services around your needs.
This new online service hosted by our technology provider Appian has been piloted with a range of MHRA’s customers over the last few weeks. The pilot has demonstrated that the new online service is far better in meeting customer needs in terms of usability, ease and efficiency.
The MHRA will now roll out the new online account to the rest of our customers from 27 November 2017. We will be contacting you directly with your go-live date and help you with getting prepared for your organisation switching over to the new Agency account.
You will have a single point of entry and single account for Device Registrations and Certificates of Free Sale.
We have designed and improved the interface for content, making our new system more usable as well as simplifying the channels our customers use to engage with us.
Your current registration will remain legally valid but with a new account reference number. You will be informed of this in due course.
As we move to implementing the new medical devices regulations, we would like you to update your registered devices with the Global Medical Device Nomenclature (GMDN). There will be no additional cost associated with the use of GMDN in our system. We appreciate that you may have used generic codes in the past and that you will now need to use additional GMDN codes/ terms to correctly detail your devices.
Customers can manage their own account and those who use it, granting them access as well as making changes to their own passwords.
Customers will be able to register General Medical Devices and IVD devices in one registration process with only one fee.
Customers can better manage their own data via the online portal.
Registered devices will be available to select for CFS and there will be no need to re-enter registered devices in the CFS system once GMDN codes are provided. However, please note that product information will need to be added (if not added in the registration service) and CE certificates will need to be uploaded again.
Customers will have the ability to track applications through real-time progress updates at each application stage.
We hope you find this information useful. If you have any further questions, please contact:
Devices Transformation Project Team
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road, London. SW1W 9SZ