The UK’s Medicines and Healthcare products Regulatory Agency has updated guidance on how to register as a manufacturer to sell medical devices.
Companies must register if they sell Class I devices they manufacture, Class 1 devices they refurbish or re-label, any system or procedure pack, custom-made medical devices, in vitro diagnostic devices they manufacture and IVDs undergoing performance evaluation.
“Manufacturers without a place of business in the EU need to appoint an authorized representative in the EU. Only one authorized representative can be designated within the EU for each product type,” the guidance says.
The guidance document, first published in December 2014, was revised last week with new information to clarify the use of the Device Online Registration System.
Regulators launched the DORS in February 2015. Devicemakers can register certain products and directly manage their details. The online registration was voluntary until May of last year, when MHRA stopped accepting paper registrations.
Manufacturers must pay roughly $95 to update their DORS record if they want to change their name, address, authorized representative or status of an in vitro diagnostic, or add device types. Changes that can be made for free include removing a device from records, changing a contact person and changing a telephone number or email address.