Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) defines a manufacturer as a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark.

The term authorized representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.

The manufacturer is responsible for the proper qualification and classification of a product as a medical device or in vitro diagnostic medical device.

The Federal Office for Safety in Health Care (BASG) performs delimitation or classifications of medical devices or in vitro diagnostic devices based on art. 10 Medical Devices Act 2021 (MPG 2021), BGBl. I Nr. 122/2021 as amended. An application for qualification or classification can only be submitted by a manufacturer or authorized representative legally based in Austria. Please note the current fee regulation. Further information on delimitation and classification is provided on the website of the European Commission.

The qualification or classification is carried out based on the provisions of the MPG 2021, which refers to MDR and, for in vitro diagnostic medical devices, IVDR. A statement on qualification or classification according to the European Directives 90/385/EEC, 93/42/EEC or 98/79/EC can NOT be derived from this.

Form for qualification/classification: Application for qualification/classification (F_I235)

Regarding the costs, please note the current Fee Regulation (section XI). 

Guidance documents (Guidance)

Please see the applicable Guidance - MDCG documents.

Information on the registration obligation can be found on the website of the Austrian Register for Medical Devices: medizinprodukteregister.at

Questions regarding registration should be addressed to the body responsible for registration, Gesundheit Österreich GmbH (GÖG) (medizinprodukte@goeg.at).

Every natural or legal person (regardless where their business is based) who provides medical devices to end users in Austria is obliged to submit a fee declaration for the previous fee year to the Federal Office for Safety in Health Care in accordance with the Medical Device Fee Regulation no later than June 30th of the following year.

Further information on the medical device fee.

According to the MDR and the IVDR, manufacturers are responsible for reporting serious incidents and safety corrective actions in the field.

As the European Database for Medical Devices (EUDAMED) is not yet fully operational, according to the MDCG 2021-1 guidance and art. 2 Electronic Submission Regulation 2011, the notification has to be done by email to medizinprodukte@basg.gv.at. The European accredited reporting forms are to be used for reporting. For field safety corrective actions (FSCA), the customer list and the field safety notice (FSN) in German must be submitted in addition to the FSCA form.

Manufacturers and authorised representatives are according to art. 93 MDR or art. 88 IVDR and art. 2 MPG 2021 subject to surveillance by the Federal Office for Safety in Health Care. Inspections are part of this market surveillance activities. An inspection can relate to all aspects that can influence the safety, functionality or quality of medical devices as well as the health of persons.

Obligation to cooperate

Companies that are inspected must assist the bodies of the Federal Office for Safety in Health Care entrusted with surveillance in the performance of their duties. They are obliged to make the premises, medical devices and records accessible to them, to permit the announced or unannounced inspection, to provide the persons and aids necessary for this purpose, and to provide the information and submit the documents that are required.

Procedure of an inspection

Preparation

• Typically, inspections are announced in writing. Information is requested in advance.
• In cases of immediate danger or if there is a justified assumption that the effectiveness of the official action will be impaired, inspections may also be carried out unannounced.
• Based on the information received, the duration and content of the inspection is determined. Subsequently, you will receive the exact inspection dates and the planned inspection contents.

On-site inspection

• The announced contents are discussed (possibly also other topics)
• Relevant documents are checked.
• Relevant areas may also be inspected.

Follow-up

• You will receive an inspection report including a description of the identified defects.
• For efficient communication regarding the follow-up of identified defects, you will receive a form with the inspection report, including a brief description of when and how the defects will be corrected and how recurrence will be prevented. In the case of critical deficiencies, evidence must be provided immediately.
• You will then receive a fee estimate. You will find the exact amount in the current fee schedule.

According to art. 59 MDR or art. 54 IVDR the placing on the market and putting into service of individual medical devices and in vitro diagnostic medical devices for which the conformity assessment procedure and CE marking have not been carried out may be authorised upon application.

A derogation may only be granted if, with regard to the sufficient supply of safe and efficient medical devices or in vitro diagnostic medical devices, the use of this medical device is in the interest of public health or patient safety or health and equivalent devices for which the conformity assessment procedure and CE marking have already been carried out are not or not sufficiently available. The derogation may be granted for a limited period of time or subject to conditions.

Derogations are generally intended for emergencies in the interest of health protection, and not for early marketing prior to completion of clinical trials or an ongoing conformity assessment procedure. It is generally assumed that there is a need in the market for such devices - this need does not constitute a sufficiently relevant reason for early placing on the market by means of a derogation.

Any derogations will be issued by means of an official decision to the applying institution if all necessary requirements are met. Please note the current Fee Regulation.

To apply for a derogation, contact medizinprodukte@basg.gv.at in advance by e-mail.