REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Austria, the responsible authority is Austrian Federal Office for Safety in Healthcare (BASG)
CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification.
Medical Devices: Class I (low), IIa, IIb, III (High)
IVD Devices: A (Low),B,C,D (high)
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I medical devices that would not require the involvement of a Notified Body and Class A IVD devices, For the other classes, it depends on the contract with the notified body and the type of device.I
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 for all classes of medical devices and a Performance Evaluation report for IVD devices in accordance with the EU regulations and guidelines is required.
LOCAL FEES: Application review fees: As per the contract with the Notified Body or the costs of the relevant Competent authority within the EU for Class I MD/Class A IVD.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
LICENSE TRANSFER: Not applicable.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative located in the EU is required for manufacturers based outside the European Union to place their devices on the EU market.
ADDITIONAL INFORMATION: The CE mark is mandatory for market access in 30 countries, including 27 Member States of the European Union and three non-EU countries that are part of the European Free Trade Association (EFTA).EU Member States that require the CE mark for include the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, The CE mark is also mandatory for products subject to EU directives sold in the following EFTA countries: Iceland, Liechtenstein, Norway.
Registration in the EUDAMED system is required for entities operating in the EU, including manufacturers (both EU and non-EU), authorized representatives, and importers.
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.
