Medical Device Registration and Approval in Austria
General country-specific regulatory information is provided on this page for medical device registration and approval in Austria. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Austria, to expedite the preparation of your medical device or IVD registration application.
Medical device regulations and classification in Austria
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Austria, devices are regulated by the BASG – Federal Office for Safety in Health Care AGES and MEA – Austrian Medicines and Medical Devices Agency.
CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk based Classification.
Medical Devices: Class I, IIa, IIb, III
IVD Devices: Annex II list A, Annex II list B, IVDs for Self-Testing, General IVD
TIMEFRAME: The registration process time frame depends on the product class.
Class I: The registration process takes about 4-6 weeks after submission.
Class II: It depends on the contract with the notified body and the type of device.
Class III: It depends on the contract with the notified body and the type of device.
IVD Devices: The registration process takes about 4-6 weeks after submission for General IVD devices. For the other classes, it depends on the contract with the notified body and the type of device.
Audits: A Quality Management System ISO 13485 is required.
Technical Local Tests: There is no need for local tests.
Clinical Evaluation/studies: A Clinical Evaluation Report in accordance with MEDDEV 2.7/1 is required.
Application review fees: As per the contract with the Notified Body.
Manufacturer registration: As per the contract with the Notified Body.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
LICENSE TRANSFER: Not applicable.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced 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 persons and companies based on Austria require additional registration in the Austrian Medical Devices Registry. This process is not required if the product is already elsewhere on the EU market and registered in the national registry of that country.
Last updated on November 19, 2018.
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