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.
SPECIAL REQUIREMENTS:
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.
LOCAL FEES:
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.
Registration is obligatory for all persons and companies (manufacturers, importers, authorized representatives, sterilizing companies, system(s) manufacturers) based in Austria AND those responsible for placing medical devices on the market (including in-vitro diagnostics and custom-made medical devices) for the first time in the European Economic Area (and Switzerland) as well as for certifies, testing laboratories and inspection bodies of medical devices based in Austria.
The registration of distributors based in Austria is voluntary but strongly recommended.
In case a CE-marked product has already been placed somewhere on the EU market (or Switzerland) and is already registered in the national registry of the corresponding country, it is not necessary to register the product again in the Austrian Medical Devices Registry.
There are no fees associated with the registration. The Austrian Medical Devices Registry operates as a cost-free online database. However, regardless of registration, according to the “Medical Devices Fee Ordinance” every person or company delivering medical devices to end users in Austria is obliged to pay an annual fee to the Federal Office for Safety in Healthcare (Bundes Amt für Sicherheit im Gesundheitswesen). More information can be found here.
