Manufacturer and representative
Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices defines a manufacturer as a natural or legal person who manufactures a device, develops a device or has a device reprocessed as new and markets that device under his own name or trademark.
The term authorized representative means any natural or legal person established in the Union who has been mandated in writing by a manufacturer established outside the Union to perform specified tasks on its behalf in fulfilment of its legal obligations, and who has accepted that mandate in writing.
Delimitation and classification
The manufacturer is responsible for the proper delineation and correct classification of a product as a medical device or in vitro diagnostic medical device.
The Federal Office for Safety in Health Care (BASG) performs demarcations or classifications of medical devices or in vitro diagnostic devices based on § 10 of the Austrian Medical Devices Act 2021 (MPG 2021). An application for delimitation or classification can only be submitted by a manufacturer or authorized representative based in Austria. The current fee tariff must be observed. On the website of the European Commission, further information on demarcation and classification is provided.
The demarcation or classification is carried out based on the provisions of the MPG 2021, which refers to Regulation (EU) 2017/745 and, for in vitro diagnostic medical devices, Regulation (EU) 2017/746. A statement on demarcation or classification according to the European Directives 90/385/EEC, 93/42/EEC or 98/79/EC can NOT be derived from this.
Application for demarcation / classification: Link to form F_I235
Please note the fee tariff.
Guidance documents (Guidance)
- MDCG 2019-11 (Software - Delimination and Classification).
- MDCG 2020-16 (IVDs - Classification)
- MDCG2021-24 (Medical devices - Classification)
- MDCG 2022-5 (Medical Devices - Pharmaceuticals)
- MEDDEV 2.1/3 (Delimitation)
- MEDDEV 2.4/1 (Classification)
- MEDDEV 2.1/6 (Software - delimitation and classification)
- MEDDEV2.14/1 (IVDs - Delimitation)
- Borderline Manual
Before products subject to the Medical Devices Regulation (EU) 2017/745 or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are placed on the market, the manufacturer as well as his authorized representative must carry out a registration in advance. More detailed information on registration can be found on the website of the Austrian Register for Medical Devices: medizinprodukteregister.at
According to the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, 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, based on the MDCG 2021-1 guidance, the notification has to be done by email to email@example.com. The European accredited reporting forms are to be used for reporting. For safety corrective actions in the field, the customer list and the safety information in German must be submitted in addition to the notification form.
Manufacturers and authorized representatives are subject to monitoring by the Federal Office for Safety in Health Care. Inspection is part of this monitoring activity. 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.
Duty 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 a medical device inspection
- Typically, inspections are announced in writing. Information is requested in advance.
- 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 procedure
- The announced contents are discussed (if necessary also other topics)
- Relevant documents are checked.
- If necessary, the manufacturing areas are inspected.
- 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.
Certificate of exemption
Upon application, 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 authorized.
A certificate of exemption 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 is in the interest of public health or patient safety or health, and equivalent products for which the conformity assessment procedure and CE marking have already been carried out are not available. The exemption may be time-limited or subject to conditions.
Certificates of Exemption are generally intended foremergencies 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 products - this need alone does not constitute a sufficiently relevant reason for early placing on the market by means of an exemption.
Possible exemptions will be issued to the applying institution by means of a notice if all necessary requirements are fulfilled. The current fee tariff must be observed.
To initiate a procedure for an exemption, contact firstname.lastname@example.org in advance by e-mail.