Medical Device Operators
Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR ) and the Austrian Medical Devices Act 2021 (MPG 2021) 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.
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:
- the death of a patient, user or other person
- the temporary or permanent serious deterioration of a patient's, user's or other person's state of health
- 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.
Information of patientsabout health hazards caused by implants(§ 41(4) MPG 2021)
In connection with
- field safety notice, or
- notifications from the BASG about existing health hazards due to implants,
the health care facilities or physicians responsible for implantation must demonstrably and without unnecessary delay inform their patients about the health hazards posed by implants.
Unique device identification system (Article 27(9) MDR, 24(9) IVDR).
Health institutions shall store and keep preferably by electronic means the Unique Device Identifier (UDI) of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices. The collection and storage should preferably be done electronically.
In addition, the UDI must be included in serious incident reports to enable correct identification of the affected device.
The MDR and IVDR introduced a new system for unique device identification called the Unique Device Identification system ("UDI system"). The UDI system is intended to facilitate the identification and traceability of medical devices. For this purpose, the manufacturer affixes a UDI on the product itself as well as on all higher packaging levels. The UDI represents an additional marking and is usually indicated both in machine-readable form (for example, by linear 1D bar code, 2D matrix bar code 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. As of May 2027, the UDI will be found on products of all risk classes.
In-House Devices (Article 5(5) MDR/Article 5 (5) IVDR).
Healthcare facilities have the option 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 Article 5(5)MDR/IVDR must be fulfilled. For example, healthcare facilities must prepare a publicly available declaration that must include the name and address of the healthcare facility, the information necessary to identify the products, and a declaration, that the devices meet the general safety and performance requirements as set out in Annex I MDR/IVDR.
Additional clarification on the requirements for in-house devices can be found in this guidance document.
Single-use devices and their reprocessing(Article 17 MDR).
The reprocessing and reuse of single-use devices is only permitted if it is allowed under national law. In Austria, both reprocessing and reuse of single-use devices are not permitted.
Implant card (Article 18 MDR, § 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, the healthcare facility must issue an implant card to these patients. The implant card is provided to the healthcare facility by the manufacturer and must be completed by the healthcare facility. Health care facilities must provide the following information:
- patient name or patient ID
- name and address of the health care facility that performed the implantation
- date of implantation
Excluded from the implant card requirement are: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
For more information on the implant card, please refer to this guidance document.
Derogation (Article 59 MDR/Article54 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 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 devices for which the conformity assessment procedure and CE marking have already been carried out are not or not sufficiently available. The exemption 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 an exemption.
Any derogations will be issued by means of a notice to the applying institution if all necessary requirements are met. The current fee tariff must be observed.
To initiate a procedure for a derogation, contact firstname.lastname@example.org in advance by e-mail.
Installation, operation, use and maintenance of medical devices (§ 49 ff MPG 2021)
Requirements for healthcare facilities for the installation, use and maintenance of medical devices are regulated in the 8th section of the MPG 2021.
Of relevance are:
- General requirements
- Commissioning, use
- Information for users
- Instruction of personnel
- 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 marketed under the 93/42/EEC, 98/79 EC or 90/385/EEC directives, the Medical Device Operator Ordinance must also be observed. For all other medical devices, the Federal Minister for Social Affairs, Health, Care and Consumer Protection has not yet issued a corresponding ordinance (Section 61 (2) (4) of the MPG 2021 provides for such an ordinance).
Cleaning, disinfection and sterilization of medical devices (§ 62 MPG 2021)
Cleaning, disinfection and sterilization of medical devices - taking into account the nature of the medical devices - shall be carried out and organized using such devices or device systems and suitable validated procedures in such a way that the success of these procedures is traceably guaranteed and the safety and health of patients, users or third parties is not endangered.
EUDAMED information source (Article 33 MDR, Article 30 IVDR).
A central element of the MDR and IVDR, respectively, is the implementation of the European Database for Medical Devices (EUDAMED). This is intended to increase transparency by, among other things, improving access to information for the public and healthcare professionals. Six different modules will be integrated into EUDAMED:
- Actors registration
- UDI/devices registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance (recording and reporting of serious incidents and field safety corrective actions) and post-market surveillance
- Market surveillance
Healthcare professionals have the possibility to obtain information about devices 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 under development. An overview of the current status can be found on the European Commission website.