Austria Medical Device Registration

Navigating Medical Device Regulatory Compliance in Austria: Insights on AGES MEA, BASG, and Market Access Requirements under MPG 2021

Regulatory Authority: Austrian Medicines and Medical Devices Agency (AGES MEA) on behalf of BASG.

The Austrian Medicines and Medical Devices Agency (AGES MEA) is the national authority for medicines, medical devices, blood, and tissue in Austria. It was formed in 2012 and is responsible for drug approval, clinical trials, pharmacovigilance, and inspection of medical devices.

The BASG monitors medicinal products and devices on the market, including their efficacy, side effects, production, transport, and storage. It also performs blood and tissue vigilance tasks.

The Austrian Agency for Health and Food Safety (AGES) is a leading expert organization for risk minimization in health, food safety, and consumer protection.

The Federal Office for Safety in Health Care (BASG) is subordinate to the Federal Ministry of Health (BMG) and consists of three members appointed by the Federal Minister.

The AGES MEA provides two members of the Federal Office. The employees of AGES MEA act on behalf of BASG during sovereign execution.

Link for Regulatory Authority: https://www.basg.gv.at/en/medical-devices

Local Regulation: Federal Law on Medical Devices (Medical Devices Act – MPG) & ordinances

Austria legal Basis

• Medical Devices Act 2021 (MPG 2021)
• Medical Device Operator Regulation
• Medical Device Reporting Ordinance
• Regulation for magnetic field therapy devices
• Regulation for the delivery of HIV tests for personal use

European Guidelines

• • Regulation (EU) 2017/745 on medical devices
  • Regulation (EU) 2017/746 on in vitro diagnostic medical devices
  • Directive 93/42/EEC
  • Directive 98/79/EC
  • Directive 90/385/EEC

https://www.basg.gv.at/ueber-uns/gesetzliche-grundlagen#c12785

Medical Device Classifications

Classes I, IIa, IIb, and III

Listing or Registration Requirements

• If manufacturer is located outside of the EEA, they must designate an Authorized Representative within the EEA or Switzerland.
• If this representative is in Austria and device is being put on the Austrian market for the first time via the EEA or Switzerland, then the representative must register with the Austrian Medical Device Registry.
• The Authorized Representative must also have their name placed on all labelling.
• Due to Austria’s membership as a country in the European Union, only devices with proper CE Markings may be placed on the Austrian market

Documents Required for Registration

Product data & info of professional/ trade license

Registration Timeline

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.

Registration Fee

To register with the Austrian Medical Device Registry, there are no fees as it operates as a cost-free online database. However, manufacturers are obligated to pay an annual fee to the Federal Office for Safety in Healthcare.

License Validity

One time registration before placing device on the market

Special Labelling Requirements

Labelling & IFU should be in German

Additional Comments

Registration may not be required for certain categories like custom-made devices or devices already legally marketed in the EU or Switzerland.

Market Access

Medical devices can only be introduced to the Union market if they adhere to the regulations outlined in the respective European regulations (MDR, IVDR). These regulations encompass compliance with general safety and performance standards, the careful selection and implementation of an appropriate conformity assessment procedure, and the issuance of a corresponding declaration of conformity. The affixation of the CE marking signifies the manufacturer’s assertion that the medical device complies with all relevant requirements.

The manufacturer bears exclusive responsibility for the medical device, encompassing its design and characteristics. The manufacturer defines the intended medical purpose, specifying the type, principal effect, and application of the medical device, and categorizes it within the applicable medical device class. In cases involving medical devices of higher risk classes, the involvement of a notified body is mandatory.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]