European Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) respectively define importer as any natural or legal person established within the Union that places a device from a third country on the Union market.

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.

Art. 37 Medical Devices Act 2021 (MPG 2021), BGBl. I Nr. 122/2021 as amended outlines a registration obligation for distributors based in Austria. This registration must be carried out with Gesundheit Österreich GmbH. You can find more information about this on the website of the Austrian Medical Devices Registry : Distributor/Dealer | medizinprodukteregister.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.

General obligations of importers and distributors are defined in art. 13 and 14. MDR or IVDR. Of these, the following should be highlighted in particular:

If an importer or distributor considers or has reason to believe that a device which it has placed on the market or made available on the market presents a serious risk or is a falsified device, it shall immediately inform the Federal Office for Safety in Health Care (BASG) as well as the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Contact with the BASG should be made by e-mail to medizinprodukte@basg.gv.at. Complaints and reports from healthcare professionals, patients or users about suspected incidents related to a device they have placed on the market or made available shall be forwarded immediately to the manufacturer and, where applicable, the authorised representative and the importer.

Distributors shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring.

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.

Art. 16 MDR or IVDR defines cases where the manufacturer's obligations also apply to importers or distributors. In accordance with art. 16 para. 4 MDR or IVDR, the manufacturer and the Federal Office for Safety in Health Care (BASG) must be informed at least 28 days before a relabelled or repackaged product is made available on the market. Please contact the BASG via e-mail to medizinprodukte@basg.gv.at.