70. Ordinance of the Federal Minister for Health, Family and Youth on the setting up, operation, application and maintenance of medical devices in health care institutions (Medical Devices Ordinance-MPBV)

On the basis of § 73 and § 80 (2) of the Medical Devices Act, BGBl. No. 657/1996, as last amended by the Federal Law BGBl. I n ° 153/2005, by the Federal Minister for Health, Family and Youth, on the basis of section 81 (1) and (3) and § 92 of the Medical Devices Act, by the Federal Minister for Health, Family and Youth, in agreement with the Federal Minister for Economic Affairs and Labour,

Scope

§ 1. This Regulation shall apply to the establishment, operation, application and maintenance of medical devices in health care facilities.

Definitions

§ 2. (1) "establishment of the health care system" means any institution, body or institution pursuant to § 2 para. 23 Medical Devices Act.

(2) "operator/operator" shall be the natural or legal person responsible for the establishment of a health care establishment.

(3) "Technical Security Officer/Technical Security Officer" is the Federal Law Gazette (BGBl) according to the implementing provisions of § 8b of the Federal Act on hospitals and health care institutions. No. 1/1957, as last amended by the Federal Law BGBl. I n ° 122/2006, person ordered.

Entry Check

§ 3. (1) The operator/operator shall be responsible for all Annex 1 , prior to its initial application at the place of operation, to carry out an entrance examination or to have it carried out. An amendment to Annex 1 can only be made after consultation of the Austrian Medical Association and the Austrian Dentistry Chamber.

(2) In hospitals, the operator has, in justified cases, an entrance examination for all medical devices mentioned in addition to the technical safety officer (s) prior to their first application at the place of business or have it carried out.

(3) The scope of the entrance examination referred to in paragraphs 1 and 2 shall be based on that of the periodic safety-technical examination in accordance with § 6. When a detailed manufacturer or supplier measurement protocol is supplied, the entrance examination can be restricted to a visual inspection of transport damage.

Briefing

§ 4. (1) The operator shall ensure that any person dealt with the handling of a medical device by medical device advisers in accordance with § 79 of the Medical Devices Act or persons who are responsible for the reasons for their Training, knowledge and practical experience for the introduction into the handling of these medical devices will be considered. The training may also be carried out by persons who are just as appropriate for the establishment of the health care system. The instructions for the proper handling of the medical devices concerned must be done in a type-related way. An instruction is not required for those persons who, on the basis of their training, other knowledge or on the basis of their practical experience, may be presumed to have the information referred to in paragraph 3 above. have been sufficiently well known.

(2) The instructions in accordance with paragraph 1 shall be documented for the following medical devices in the device file or in other content-like recordings, such as distributed files or files:

1.		Medical devices referred to in Annex 1 and
2.		Medical devices designated by the Technical Security Officer (s).

(3) The instructions referred to in paragraph 1 shall contain information on:

1.		all relevant aspects for the proper handling of the medical product,
2.		the application in accordance with the instructions for use as well as necessary safety-relevant criteria,
3.		the proper preparation, upgrading and conversion of equipment, and permissible combinations of equipment,
4.		the checks to be carried out before each application, and
5.		the maintenance and intervals to be carried out by the user and the user.

(4) The documentation referred to in paragraph 2 shall contain:

1.		Device name, manufacturer, type,
2.		name and date of birth or staff number of the person who has been denied,
3.		the name of the date of entry and the date of entry, and
4.		Signature of the registered person as confirmation that she/he has been admitted to the correct handling of the respective medical device and understood the contents of the instruction.

(5) Documented instructions from a user are to be recognised by other healthcare institutions.

(6) The operator shall, if necessary, provide for recurrent training, in particular where:

1.		the training needs of the user, or
2.		repeated incorrect operations, or
3.		Functional or operating changes according to software updates or upgrades, or
4.		Modification of the application or application area of a product.

Maintenance

§ 5. (1) The maintenance shall be carried out in the light of the manufacturer's information and shall be organised in such a way as to ensure the safety and health of the health care system, in terms of the nature, size and task of the establishment of the health care system; Patients, users, or third parties will not be compromised.

(2) Spare parts used in the repair process and any adjuvants or substances used must be equivalent to the original parts and the original auxiliaries or substances in terms of their suitability and choice and their technical characteristics. When using original spare parts, this requirement is considered to be fulfilled.

Recurrent safety testing

§ 6. (1) The operator/operator has

1.		in the case of active non-implantable medical devices and
2.		At the request of the manufacturer even in the case of non-active non-implantable
to carry out a periodic safety test or to have it carried out.

(2) (1) (1) does not apply to active non-implantable medical devices which are not listed in Annex 1 and which are exclusively battery-powered, unless the manufacturer has a recurrent safety test for these medical devices mandatory.

(3) If the manufacturer has prescribed a periodic safety test, it shall be carried out in accordance with the test scope contained in the accompanying documents and in the specified test interval. In individual cases, which are to be justified in terms of safety, a person suitable for technical reasons can prescribe a shorter test interval or extend the scope of the test. Such provisions shall be documented together with the justifications. Where the manufacturer has expressly ruled out the need for a periodic safety check, at least a visual inspection shall be carried out. Periodic safety tests can be carried out for medical devices in medical devices of the Federal Army for the duration of an operation in accordance with § 2 para. 1 lit. a of the Wehrgesetz 2001 (WG 2001), BGBl. I n ° 146, as last amended by BGBl. I No 116/2006, as well as in the immediate preparation of such an operation.

(4) If data from the manufacturer are not available for a periodic safety test, the periodic safety test, which shall also include safety-relevant functional checks, shall be in accordance with the state of the art ,

(5) Where no manufacturer's information is available for the test interval, it shall be determined by a qualified person, the test interval, taking into account the type of equipment and the hazard potential, as a general rule between six and 36 months, in the case of the medical devices listed in Annex 1, however, between six and 24 months. The hazard potential is determined by the degree of risk of the device, the frequency of use, the unenforceability of the device, the place of operation (in particular the ordination site or hospital), ownership conditions, location of use (stationary, mobile, emergency), and Error frequency should be taken into account. Exceeding of the test interval determined by the person suitable for the subject is permitted, taking into account the type of equipment and the hazard potential of up to six months.

(6) The paragraphs 1 to 5 shall also apply to the interconnection of active medical devices with other medical devices or non-medical products to active medical systems.

(7) A periodic safety test may only be carried out by persons or bodies which meet the requirements of Annex 3 .

(8) The periodic safety assessment shall be carried out with a protocol identifying the examiner's identification, the date of implementation, the type and extent of the test, and the results, indicating the measured values determined. and the measurement procedure, as well as the overall assessment. The operator shall keep the protocol for at least five years.

(9) The medical devices tested shall be marked with the date of the next examination (month, year) upon successful examination.

Metrological controls

§ 7. (1) The operator/operator shall carry out metrological checks including calibration and evaluation for the purpose of repatriation to national or international standards or to be carried out for the purpose of repatriation.

1.		in the Annex 2 For the medical devices listed in Z 5 and 6, the metrological control from the calibration in accordance with the measure and calibration law, BGBl. No 152/1950, as last amended by BGBl. I n ° 137/2004, and
2.		Medical devices other than those mentioned in Annex 2, but for which the manufacturer has provided such controls in the accompanying documents.

(2) The measurement controls shall be based on the error limits specified by the manufacturer in his instructions for use. If such indications are not included in the instructions for use, the limits of error laid down in harmonized standards in accordance with § 2 para. 15 of the Medical Devices Act shall be complied with. If harmonized standards are not available, the state of the art should be based on.

(3) Persons or bodies carrying out metrological checks may use only metrological standards for these controls, which are traceable to a national or international standard and which are sufficiently small to limit errors and Observe the measurement uncertainties. The error limits shall be considered to be sufficiently small if they do not exceed one third of the established fault limits of the medical device.

(4) Measurement checks shall be carried out at the intervals specified by the manufacturer. Where the manufacturer is not responsible for the indication of intervals for the medical devices referred to in Annex 2, the intervals referred to in Annex 2 shall be used. Exceeding these intervals shall be permitted, taking into account the type of equipment and the hazard potential of up to six months.

(5) In the case of the medical devices listed in Annex 2, the manufacturer shall explicitly remove the need for regular metrological controls and shall carry out metrological checks only in the cases referred to in paragraph 6. If the manufacturer does not specify any intervals in the case of medical devices referred to in paragraph 1 (2), the operator must carry out or have carried out metrological checks at intervals which ensure that the relevant deficiencies, with which they are based, are The reason for the experience must be expected in time, but at least every two years.

(6) A metrological control shall be carried out without delay if:

1.		there are indications that the medical device does not comply with the error limits set out in paragraph 2, or
2.		the metrological properties of the medical device could have been influenced.

(7) Measurement checks may only be carried out by persons or bodies which meet the requirements of Annex 4 . The physico-technical inspection service of the Federal Office of Eich-und Vermessungswesen and relevant calibration standards accredited for the relevant product range shall be deemed to be appropriate within the meaning of Annex 4.

(8) Medical devices must be marked after successful metrological control. The marking must include the year of the next metrological control and the body which has carried out metrological control.

Device File

§ 8. (1) For medical devices provided for recurring safety tests in accordance with § 6 or metrological checks in accordance with § 7, the operator shall have a controller/controller or several responsible persons responsible for the safety and security of the medical device. for the guidance of a device file containing the information referred to in paragraph 2. For the device file, all data carriers, including the form of paper, shall be permitted to ensure the availability of the information referred to in paragraph 2 during the period of the retention period.

(2) The following information shall be entered in the device file:

1.		Name and other information on the item-related identification of the medical device,
2.		Purchase date,
3.		Documentation of the entrance examination in accordance with § 3,
4.		Instructions in accordance with § 4, provided that they are not kept in separate records,
5.		intervals, the date of implementation and the results of the periodic safety checks required in accordance with § 6 and the name of the responsible person or body responsible for carrying out these tests,
6.		intervals, the date of implementation and the results of the metrological checks in accordance with § 7 and the name of the responsible person or body responsible for carrying out these tests,
7.		the date, type of repairs and the results of checks carried out after repairs, and the name of the person or body which carried out this measure,
8.		where there are contracts with persons or bodies for the carrying out of periodic safety tests or metrological checks or maintenance measures, the name and address of which shall be:
9.		Date, type and consequences of safety incidents (malfunctions, operating errors),
10.		Date and content of the notifications pursuant to § 70 Medical Devices Act, and
11.		Date of final decommissioning.

(3) The device file shall be stored in such a way as to be accessible during the operating period. If the medical device is finally withdrawn, its data shall be kept for at least five years in the device file.

(4) For manual blood pressure measuring devices, battery-operated light sources (e.g. flashlights), pulse measuring devices that are not used for monitoring, and electrical fever thermometers, there is no obligation to guide a device file.

Inventory Directory

§ 9. (1) The operator/operator shall have an inventory list for all active medical devices available for use.

(2) The following information shall be entered in the inventory list:

1.		Name, type and type, lot code or serial number, year of manufacture,
2.		the name and address of the manufacturer;
3.		the name and address of the trader;
4.		the identification number of the notified body which may be added to the CE marking, and
5.		Location or operational allocation.

(3) All data carriers, including the form of paper, shall be permitted for the inventory directory, which shall ensure the availability of the information referred to in paragraph 2 during the period of retention.

(4) The inventory directory can be jointly run with the device file according to § 8.

Implant Registry

§ 10. (1) The operator/operator shall be responsible for all implantable medical devices in accordance with Annex 5 to lead an implant register.

(2) The implant register shall be maintained in such a way as to ensure rapid identification of implants and patients to protect the health and safety of patients.

(3) The implant register shall contain the following information:

1.		Name, type and type, lot code or serial number of the implant,
2.		the name and address of the manufacturer;
3.		the name and address of the trader;
4.		Name and social security number of the patient,
5.		Date of implantation,
6.		the name of the person responsible for the implantation, and
7.		Intervals of the subsequent check-ups on the basis of the manufacturer's instructions.

(4) The device or person responsible for the implantation of a medical device must document the data according to paragraph 3 and store it 30 years after the implantation. In addition, these data are to be attached to the patient information in accordance with § 81 para. 2 Medical Devices Act.

(5) All data carriers including the form of paper are permitted for the implant register, which ensure the availability of the information referred to in paragraph 3 during the period of the retention period.

Transitional and final provisions

§ 11. (1) Entrance exams according to § 3, instructions in accordance with § 4, recurring safety tests in accordance with § 6 or metrological checks in accordance with § 7 equivalent tests, instructions and controls as well as a device file according to § 8 and a Inventory according to § 9 of equivalent documentation which has been carried out or has been carried out under other legislation, or are to be recognized.

(2) For medical devices operated or used at the time of entry into force of this Regulation, and which continue to be in use beyond 31 March 2008,

1.		the periodic safety test in accordance with § 6,
2.		the metrological controls referred to in § 7,
3.		the device file according to § 8, and
4.		the inventory according to § 9
shall be carried out or applied at the latest by the end of 31 March 2008 at the latest, in so far as it does not result in periodic safety tests and metrological checks in sections 6 and 7 of this Article.

(3) For medical devices operated or used at the time of entry into force of this Regulation and which continue to be in use, but are definitively withdrawn before the end of 31 March 2008, recurrent safety tests in accordance with § 6 and metrological checks according to § 7 only if this results from § § 6 and 7 up to the date of the final decommissioning. § § 8 and 9 are not applicable to these medical devices.

In-force pedals

§ 12. This Regulation shall enter into force on 1 April 2007.

Kdolsky

Annex 1

Products for which special safety precautions are to be taken

1.		active non-implantable medical devices/systems to/
a)			Generation and use of electrical energy to directly influence the function of nerves and/or muscles, including defibrillators,
b)			Use of the central cardiovascular system,
c)			Generation and use of any energy for direct coagulation, tissue destruction or removal, destruction of deposits in organs or in the bloodstream,
d)			the direct introduction of substances and liquids (also prepared or specially treated body-own, the introduction of which is directly coupled with a removal function) into the bloodstream under a potential pressure buildup. Substances and liquids can
e)			mechanical ventilation with or without anaesthesia,
f)			Diagnosis using imaging techniques based on the magnetic resonance principle with superconducting coils,
g)			Therapy by means of hypothermia,
h)			Monitoring of vital parameters (but only if they are actually used for monitoring purposes).
2.		Infant incubators
3.		External active components of active implants
4.		Pressure chambers

Annex 2

Medical devices subject to metrological controls

		Post-Checker in years
	1. Medical products for acoustic determination of hearing ability (e.g. sound and speech audiometer)	1
	2. Medical products to determine body temperature:
	(a) Electrothermometer	2
	b) Medical products with exchangeable temperature sensors	2
	c) Infrared radiation thermometer	1
	3. Medical products for pressure measurement:
	a) Medical products for non-invasive blood pressure measurement	2
	b) Medical products for the determination of intraocular pressure (Augentonometer)	2
	4. Diagnostic counter-crank ergometer for patient/patient exertion	2
	5. Therapy and diagnostic dosimeters
	6. Medical personal scales (scales for medical purposes)

Annex 3

Suitability for recurrent safety tests

Requirements for examiners and verifiers:

1.		Training and expert knowledge of the examiner:
a)			Completion of a relevant technical training
b)			Knowledge of the mode of operation and the particular hazard potential of the equipment to be tested
c)			continuing education and training
d)			Knowledge of the laws, regulations and standards relevant to the test activity
e)			adequate testing practice in the field of medical technology
2.		Necessary measuring and testing equipment for carrying out the tests
3.		Reliability
4.		Organisational requirements for the planning, execution and evaluation of examinations, as well as a relevant industrial property

Annex 4

Suitability for metrological controls

Requirements to be met by the examiner and bodies:

1.		Training and expert knowledge of the examiner:
a)			the completion of a relevant technical training;
b)			continuing education and training
c)			Knowledge of the laws, regulations and standards relevant to the metrological controls
2.		Necessary measuring and testing equipment for carrying out the tests (suitability, traceability to national or international standards, indication of ownership conditions; maintenance, recalibration):
3.		Reliability
4.		Organisational requirements for the planning, implementation and evaluation of calibrations and tests as well as a relevant commercial authorization

Annex 5

List of medical devices to be included in the implant register

1.		Active implantable medical devices including implanted accessories (e.g. cardiac pacemakers, cochlear implants, electrodes, etc.)
2.		Non-active implantable medical devices:
-				Joint implants (e.g. hip joint implants, knee joint implants, etc.)
-				Soft-part implants (e.g. breast implants, etc.)
-				Organ implants (e.g. artificial heart valves, etc.)
-				Implants in the central circulatory system within the meaning of Annex IX to Directive 93 /42/EEC (e.g. stents, Vena cava filters, etc.)