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Regulatory News | 03 February 2015 | By Stewart Eisenhart •
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
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 11 February 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.
Using DORS will be optional for qualifying manufacturers until 11 May 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.
Original post at Emergo's Blog
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Tags: Class I, Devices Online Registration System, DORS