UK Regulators Introduce Online Registry For Low-Risk Medical Devices
On February 11, 2015, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) will launch the Devices Online Registration System (DORS), a web-based registry for low-risk, Class 1 medical devices.
DORS is intended to assist medical device manufacturers, assemblers, and their respective authorized representatives in electronic registration of their products with the agency. In addition to Class 1 devices, the new system can also be used to register system and procedure packs, custom-made devices, custom-made active implantable devices, and in vitro diagnostics (IVDs).
According to the Emergo Group, DORS relates to the requirements from Article 14 of the MDD (Medical Device Directive) 93/42/EEC, which obligate Class 1 devices manufacturers and authorized representatives to register with proper authorities in the European member state where they are based.
A fee of £70.00 will be issued for new and modified registrations. Manufacturers will only need to create an online account to make changes to their details or to register a new medical device.
MHRA said it will only accept online registrations for applicable devices after May 11, 2015. Until that date, qualifying manufacturers may still submit paper registrations.
Last month, the agency announced that it has also migrated its own website to GOV.UK to better serve its users.