British Regulators Launching Online Registration System for Class I Devices
The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on February 11, 2015.
The new Devices Online Registration System (DORS) will facilitate online registration of Class I devices, as well as custom-made devices and custom-made active implantable devices. In vitro diagnostic (IVD) device manufacturers will also be able to register their products with the MHRA using DORS. The new system pertains to regulatory requirements laid out in Article 14 of the MDD 93/42/EEC that require manufacturers and Authorized Representatives of Class I devices to notify the Competent Authority in the European member state in which they are based.
Using DORS will be optional for qualifying manufacturers until May 11, 2015, after which MHRA will no longer accept paper registration applications and will require online registration. The agency will charge a £70 fee for new and modified registrations submitted through DORS.
To learn more about medical device regulations and CE Marking requirements in the UK and Europe, see our video overview of the European CE Marking process.