REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In the Sweden, devices are regulated by the Medical Products Agency (MPA).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
All Swedish manufacturers and authorized representatives of the following products shall sign up for registration with the Swedish Medical Products Agency:
· in vitro diagnostic products
· medical devices in class I, Is and Im
· custom-made medical devices
· module and procedure packs
· national medical information systems (NMI)