Requirements for healthcare facilities and healthcare professionals in connection with medical devices

Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR ) and the Medical Devices Act 2021 (MPG 2021), BGBl. I Nr. 122/2021, as amended define the requirements for healthcare facilities and healthcare professionals in connection with medical devices.

An overview of the requirements can be found in the checklist for healthcare facilities.

Art. 40 and 41 MPG 2021

Electrical form for incidents with medical devices

Professionals who use or operate medical devices, as well as technical safety officers of hospitals, must immediately report to the Federal Office for Safety in Health Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The manufacturer or, if applicable, the authorized representative of the product must also be informed. In the case of hospitals, this must be done uniformly by way of the medical director, except in the case of other imminent danger.

A serious incident is defined as an incident that directly or indirectly led, might have led or might lead to any of the following:

1. the death of a patient, user or other person
2. the temporary or permanent serious deterioration of a patient's, user's or other person's state of health
3. a serious public health threat

If there is a suspicion of counterfeiting of a medical device, this must be reported immediately to the BASG.

Products involved in incidents must not be destroyed, but must be subjected to a root cause analysis. In this context, the healthcare institution is obliged to safeguard the legal position of the patient or any survivors with regard to the significance of the medical device for the enforcement of any liability claims.

on health hazards due to implants (Art. 41 para. 4 MPG 2021)

In connection with

• Safety instructions in the field, or
• notifications from the BASG about existing health hazards from implants,

the healthcare facilities or physicians responsible for the implantation must demonstrably and without unnecessary delay inform their patients about the health risks posed by implants.

Art. 27 para. 9 MDR or art 24 para. 9 IVDR

Healthcare institutions are obliged to record and store the Unique Device Identifier (UDI) of Class III implantable devices that they have supplied or received. Recording and storage should preferably be carried out electronically.

In addition, the UDI must be provided in reports of serious incidents in order to enable correct identification of the affected medical device.

The MDR and IVDR introduced a new system for unique device identification, the so-called Unique Device Identification system ("UDI system"). The UDI system is intended to facilitate the identification and traceability of medical devices. The manufacturer affixes a UDI to the product itself and to all higher packaging levels. The UDI is an additional marking and is usually provided in both machine-readable form (e.g. linear 1D barcodes, 2D matrix barcodes or RFID) and in human-readable form (as a numeric or alphanumeric code). Different transition periods have been set for the implementation of the UDI system depending on the risk class of the product. From May 2027, the UDI will be found on products of all risk classes.

Art. 5 para. 5 MDR or IVDR

Healthcare institutions have the possibility to manufacture and use devices in-house to address the specific needs of target patient groups that cannot be met by a similar device available on the market. When manufacturing and using such "in-house" devices, the requirements of Art. 5 para. 5 MDR or IVDR must be observed. For example, healthcare institutions must draw up a publicly accessible declaration that must include the name and address of the healthcare institution, the information required to identify the devices and a declaration of compliance with the Essential Safety and Performance Requirements in accordance with Annex I MDR/IVDR.

Additional explanations on the requirements for in-house devices can be found in this guidance document.

Art. 17 MDR

The reprocessing and reuse of single-use devices is only permitted if it is allowed under national law. In Austria, neither the reprocessing nor the reuse of single-use devices is permitted.

Art. 18 MDR and Art. 50 para. 2 MPG 2021

Healthcare facilities must provide patients who have been implanted with a device with information about the respective devices. In addition, these patients must be issued with an implant card by the healthcare facility. The implant card is provided to the healthcare facility by the manufacturer and must be filled in by the healthcare facility. Healthcare facilities must provide the following information:

• Patient name or patient ID
• Name and address of the healthcare facility that carried out the implantation
• Date of implantation

Excluded from the obligation of the implant card are sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clamps and connectors.

Further information on the implant card can be found in this guidance document.

Art. 59 MDR or Art. 54 IVDR

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 derogation may only be granted if, with regard to the adequate supply of safe and effective medical devices or in vitro diagnostic medical devices, the use of such devices 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 or subject to conditions.

Derogations are generally limited to emergencies in the interest of health protection and are not intended for early placing on the market before the completion of clinical trials or an ongoing conformity assessment procedure. It is generally assumed that a medical need is indicated for such products. Any other need does not constitute a sufficient reason for early placing on the market by means of a derogation.

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

Applications for a derogation must be sent by e-mail to medizinprodukte@basg.gv.at.

Art. 49 ff MPG 2021

Requirements for healthcare facilities for the installation, use and maintenance of medical devices are regulated in Section 8 of the MPG 2021.

The following are relevant:

• General requirements
• Commissioning, use
• Information for users
• Instruction of the personnel
• Inventory list
• Maintenance of medical devices
• Periodic safety inspection
• Evaluation and documentation of tests, device file
• Suitability for testing
• Avoidance of hazards

For products that are still placed on the market under Directives 93/42/EEC, 98/79 EC or 90/385/EEC, the Medical Devices Operator Regulation must also be taken into account. For all other medical devices, the Federal Minister of Social Affairs, Health, Care and Consumer Protection has not yet issued a corresponding regulation (Art. 61 MPG 2021 provides an option for such a regulation).

Art. 62 MPG 2021

Cleaning, disinfection and sterilization of medical devices must be carried out and organized - taking into account the type of medical devices - with such devices or device systems and suitable validated procedures in such a way that the success of these procedures is reproducibly guaranteed and the safety and health of patients, users or third parties is not endangered.

Art. 33 MDR or Art. 30 IVDR

A central element of the MDR and IVDR is the implementation of the European database for medical devices (EUDAMED). This is intended to increase transparency by improving access to information for the public and healthcare professionals. Six different modules will be integrated into EUDAMED:

1. Actors registration
2. UDI/medical device registration
3. Notified bodies and certificates
4. Clinical investigations and performance studies
5. Vigilance (recording and reporting of serious incidents and field safety corrective actions) and post-market surveillance
6. Market surveillance

Healthcare professionals have the possibility to obtain information about products on the market in EUDAMED. This includes, for example, field safety notices and the summary of safety and clinical performance. Please note that EUDAMED is currently still under development. An overview of the current status can be found on the website of the European Commission.