Online Registration of Medical Devices in UK

HMS computerThe authority for registration of medical devices in the U.K., Medicines and Healthcare products Regulatory Agency (MHRA) launched an online registration system earlier this month. The Devices Online Registration System (DORS) is for low-risk, Class 1 medical devices, as well as system and procedure packs, custom-made devices, custom-made active implantable devices, and in vitro diagnostics (IVDs).

Electronic registration of products is currently optional, but MHRA will stop accepting paper applications after May 11, 2015. Visit DORS to register medical devices, in compliance with Article 14 of the Medical Device Directive 93/42/EEC, which requires registration of Class 1 devices in the U.K.

Source: MHRA | Emergo Group