121. Regulation of the Federal Minister for Science, Research and the Economy on vocational training in the teaching profession Medical productsaufmann/-frau (Medizinprodukte-kaufmann/-frau-Ausbildungsordnung)

Due to § § 8 and 24 of the Vocational Training Act (BAG), BGBl. No. 142/1969, as last amended by the Federal Law BGBl. I No 129/2013, shall be arranged:

Teaching profession Medical productsaufmann/-woman

§ 1. (1) The teaching profession Medical Product Man/Women is set up with a teaching period of three years as an educational experiment.

(2) Training in the medical device for medical products can take place until 30 June 2020.

(3) In the teaching contracts, teaching certificates, teaching certificates and teaching letters, the teaching profession is to be described in the form corresponding to the sex of the apprentiate (medical device or medical product).

Professional profile

§ 2. Due to the vocational training in the course of teaching and in the vocational school, the apprentice trained in the teaching profession is to be able to carry out the following activities professionally, independently and in a responsible way:

1.		identify the requirements for the procurement of goods and the execution of goods orders in the form of communication in the normal way;
2.		Procurement, taking into account new technologies,
3.		control incoming goods, implement measures in the event of delay in delivery, non-delivery, misdelivery or warranty cases,
4.		Were stored and maintained also with regard to hygiene as well as handling with sterile products,
5.		prepare, provide and present sales-friendly product range,
6.		inform and advise on the properties, uses, maintenance and quality of medical devices, as well as to train customers,
7.		offering services,
8.		Transports (also for special medical product groups such as dangerous goods, etc.) organizing,
9.		hold sales talks,
10.		Accept orders and customer orders and process them, including billing and payment transactions, as well as carrying out the item tracking in the event of a start,
11.		Treat customer complaints.

Professional image

§ 3. (1) The following vocational training is defined for the training in the teaching profession Medical Product Man/woman. The skills and knowledge referred to shall be conveyed, at the latest in the teaching year referred to in each case, in such a way as to enable the apprentice to pursue qualified activities in the sense of the professional profile, which shall, in particular: Independent planning, carrying out, controlling and optimising.

Pos.		1. Year of Teacher	2. Year of Teacher		3. Year of Teacher
	1.	The teaching establishment
	1.1	Knowledge of the teaching profession
	1.1.1	Knowledge of the operational and legal form of the teaching staff
	1.1.2	Knowledge of the goals and the market position of the teaching company as well as the location influence		-		-
	1.2	Facilities, occupational safety and accident prevention
	1.2.1	Functional use of the company's facilities and equipment
	1.2.2	Knowledge of health, accident and environmental hazards, as well as the relevant protection and safety regulations
	1.2.3	Knowledge of regulatory bodies, social insurance and advocacy groups, as well as the labour law provisions which are subject to the law
	1.3	Training in the dual system
	1.3.1	Knowledge of the teaching partners and the obligations arising from the apprenticeship contract (§ 9 and § 10 BAG)
	1.3.2	Basic knowledge of the content of the laws that are subject to the law
	1.3.3	Knowledge of the content and objectives of training, as well as relevant training opportunities
	1.4	Organisation and inventory management
	1.4.1	Knowledge of the organizational structure as well as the tasks and responsibilities of the individual operating areas
	1.4.2	Knowledge of operational technical aids and implementation of simple operation of existing EDP applications
	1.4.3	Knowledge of the most important operational workflows in particular of the safety-related obligations arising from the MPG (Medical Devices Act)		Knowledge of the operational workflows, the operational goods movement and the resulting supporting documents		-
	1.4.4	Knowledge of the transactions subject to reporting and the measures to be deducted from them, such as the notification to the competent authority (Federal Office for Safety and Health-BASG)		Co-operating with the competent authority BASG in cooperation with the responsible person responsible for the processing of notifiable transactions such as the notification to the competent authority BASG
	1.4.5	Basic knowledge of quality management systems in the field of medical products		Knowledge of quality management systems in the field of medical devices (e.g. medical products-vigilance, batch management, article traceability)
	1.4.6	-		Assist in item tracking in the event of a start		Performing item tracking in the event case
	1.4.7	-		-		Knowledge of operational costs, their composition and their impact on profitability and pricing
	1.4.8	Basic knowledge of computer-aided acquisition, control and control of the operational movement of goods		Recording of the operational movement of goods
	1.4.9	Basic knowledge of the documents required for business-related tasks and functions of the accounting system
	2.	Cross-disciplinary training (key qualifications) In the Type of mediation The technical knowledge and skills are to be taken into consideration for the promotion of the following interdisciplinary skills of the apprentiate:
	2.1	Method competence: Develop solution strategies, obtain information independently, select and structure information, make decisions, etc.
	2.2	Social competence: Work in teams, lead employees, etc.
	2.3	Personnel competence: Self-confidence and self-confidence, willingness to develop further education, needs and interests articulate, etc.
	2.4	Communicative competence: Communicate with customers, superiors, colleagues and other groups of people in a target-group-friendly way; speak English at the level of industry and up-to-the-day skills to contest everyday and technical discussions
	2.5	Working principles: zB care, reliability, responsibility, punctuality etc.
	2.6	Customer orientation: In the centre of all activities in operation, the orientation must be based on the needs of the customers, taking into account the security
	3.	Procurement and storage
	3.1	Purchase Planning
	3.1.1	-		Participation in the determination of the demand using standard recordings and communication equipment		Determination of the demand using standard recordings and communication tools
	3.1.2	-		Knowledge of order quantities and order points in compliance with the customer's purchasing habits		-
	3.1.3	-		Knowledge of the sources of supply and shopping opportunities		-
	3.1.4	Knowledge of the conformity assessment procedure for the approval of medical devices in the EU area (e.g. CE mark, notified bodies, declaration of conformity, etc.)				Take part in the aptitude test of new suppliers and/or products
	3.1.5	-		Knowledge of the conditions and regulations of the goods cover relevant for the operation		-
	3.1.6	-		-		Knowledge of the usual terms of delivery and payment
	3.2	Purchase Handling
	3.2.1	-		Knowledge of the International Commercial Terms (Incoterms) and their importance for purchasing		-
	3.2.2	-		Carrying out orders in the usual mode of communication, taking into account quantity, price and quality
	3.2.3	-		-		Monitor delivery dates and take measures in case of delivery delay
	3.3	Receipt and acceptance of goods
	3.3.1	Check incoming goods (eg on expiration date, traffic capacity, CE mark, etc.)				Processing the delivery documents
	3.3.2	-		Detect defects and take measures (e.g. locking bearings, quarantine bearings, retournation, disposal), including written work,
	3.4	Transport of goods
	3.4.1	Knowledge of the specific requirements for the transport of certain medical devices, such as transport of dangerous goods, TRC transports, etc.				-
	3.4.2	-		Organizing transport (also for special medical product groups such as dangerous goods, etc.)
	3.5	Inventory
	3.5.1	Basic knowledge of essential storage requirements for goods
	3.5.2	-		Knowledge of the organization and the work processes in the warehouse
	3.5.3	Product-friendly storage in compliance with order, safety and cost-effectiveness
	3.5.4	-		Knowledge of the importance and co-working of the inventory
	3.5.5	Knowledge of industry-specific, plant-specific and product-specific storage regulations, in particular with regard to hygiene
	3.5.6	Knowledge of the warehouse organisation (e.g. first-in-first-out) and the flow of goods during operation				-
	3.5.7	-		Management and control of the warehouse, detection and monitoring (also with regard to hygiene) of the storage stock
	3.5.8	Knowledge and participation in environmentally sound waste management (prevention, separation, recovery and disposal)
	4.	Sale
	4.1	Sales preparation
	4.1.1	Perform preliminary work on the sale
	4.1.2	-		Knowledge of the pricing rules, performance of pricing
	4.1.3	-		Determining the inventory and inventory overview
	4.1.4	-		Specialist goods placing
	4.1.5	-		Knowledge of and participation in the appropriate waste management in the field of law-and farm-related waste management
	4.2	Goods Cortiment
	4.2.1	General product categories (technical composition, width, depth and origin, properties, nature, shape, design, grades, sizes, and uses and environmental compatibility)
	4.2.2	Knowledge of commercial and industry standard goods and trade marks (European Article Number [EAN] codes, identification symbols, etc.) and technical terms
	4.2.3	Knowledge of basic rules and measures relevant to the operation of the environment
	4.2.4	Knowledge of the operational product range with regard to the technical composition, breadth, depth and origin, properties, structure, function, operation and operation of medical devices (such as sterile products, technical aids for disabled persons, orthopaedic technology and reusable instruments, dental products, single-use products, ophthalmic and optical products, active implantable products, anaesthesia and ventilators, electromedical and mechanical products, hospital inventory, non-active implantable products, X-ray and other imaging devices)
	4.2.5	Knowledge of hygiene measures in the handling of medical devices				-
	4.2.6	Handling sterile products				-
	4.2.7	-		Knowledge of the industry-specific legal provisions such as the Medical Devices Act (MPG), classification of medical devices, medical device operator regulation (MPBV) etc.
	4.2.8	Industry-specific basic knowledge of other legal regulations such as drug law, health care law, health care law, medical law, social security law, etc.				Industry-specific basic knowledge of other legal regulations such as Electrical Engineering Act, Radiation Protection Act and Radiation Protection Ordinance, Measures and Verification Act, Gehobene Medical-Technical Services Act, Prize-Law, ÖVE-Standards, etc.
	4.2.9	-		Basic knowledge of industry-specific chemistry and physics
	4.2.10	Knowledge of interdisciplinary cooperation in health and social services
	4.3	Sales promotion and advertising
	4.3.1	Designing a sales-oriented product presentation
	4.3.2	Perform simple decorations, such as interior decorations
	4.3.3	Knowledge of the importance of the company's appearance
	4.3.4	-		Knowledge of the objectives, the implementation and modes of action of advertising and decoration in compliance with the relevant regulations in the MPG
	4.3.5	-		Participate in organizing and carrying out business-specific sales promotion measures
	4.4	Customer advice and sales
	4.4.1	Knowledge of customer-friendly behavior and customer-friendly communication
	4.4.2	Knowledge of the customer base with its shopping habits and customer behavior				-
	4.4.3	Knowledge of the flow and the design of the sales discussion
	4.4.4	Conduct sales discussions, determine customer needs and wishes, derive sales arguments, take into account the questions and objections of the customers
	4.4.5	-		Inform, advise, supervise (zB measures, adapt medical devices) and, where appropriate, inschools of customers with regard to product characteristics, uses, goods maintenance, quality of goods, quality and price differences (as far as possible) these activities are not reserved for any other regulated trade)
	4.4.6	Knowledge of the necessary documentation of customer enrolment and product transfer for certain products according to MPG and MPBV				-
	4.4.7	-		Assist in documenting customer enrolment and product delivery		Document customer training and product transfer
	4.4.8	-		Knowledge of the prescribed intervals of recurring safety testing (STK) and metrological control (MTK) according to MPBV
	4.4.9	Offer of supplementary and replacement goods and services, professional packaging and the consequences of the goods
	4.4.10	-		Knowledge of reprocessing (replacement of damaged components, refilling of containers, attachment of accessories and regular waiting, cleaning, recycling) of medical devices (as far as these activities do not regulate any other (i) (i)
	4.4.11	-		Participation in the reprocessing of medical devices (insofar as these activities are not reserved for any other regulated profession)		Reprocessing of medical devices (insofar as these activities are not reserved for any other regulated profession)
	4.4.12	-		Knowledge of the sales-related legal provisions
	4.4.13	Basic knowledge of the locomotor system as well as its pathology, the cardiovascular system, the urogenital system, the respiration and the digestive system
	4.4.14	Knowledge of the most important industry-relevant medical terminology
	4.4.15	-		-		Advice and advice on the importance of hygienic measures in the application of medical devices
	4.4.16	Knowledge and implementation of data protection, the obligation of silence and confidentiality
	4.5	Sales Accounting
	4.5.1	-		Knowledge of the operational payment transactions with suppliers, customers, authorities, money and credit institutions
	4.5.2	-		Handling of sales transactions with the cash or goods management system used during operation by means of a cash and cash payment as well as the operational security measures associated with it
	4.5.3	-		-		Basic knowledge of the relevant taxes and duties
	4.5.4	-		-		Completion of invoices taking into account the sales tax
	4.5.5	-		Completion of the documents used in the holding, including calculation and expellees of the sales tax
	4.5.6	Creating cashier reports
	4.5.7	-		Knowledge of the billing process of healing remedies
	4.5.8	-		-		Determining the sales price

(2) The provisions of the Children's and Young People's Employment Act 1987 (KJBG), BGBl, are the teaching of all vocational training positions. No 599/1987.

Rejecting Audit

Outline

§ 4. (1) The final examination is divided into a theoretical and a practical test.

(2) The theoretical examination shall comprise the subject-matter of the business case.

(3) The theoretical examination shall not apply if the candidate for the examination is to reach the target of the last class of the professional vocational school or the successful completion of a vocational middle or higher vocational training course which replaces the apprenticeship period. School has proven.

(4) The practical examination shall include the items of test work and expert discussion.

Theoretical examination

General provisions

§ 5. (1) The theoretical examination shall be carried out in writing. It can be carried out jointly for a larger number of candidates, if this is possible without adversely affecting the examination process.

(2) The theoretical examination should normally be held prior to the practical examination.

(3) The tasks shall be in accordance with the scope and level of the purpose of the final examination and the requirements of the professional practice.

Business Case

§ 6. (1) The examination shall include a business case, including the related written and payment transactions, and shall cover all of the following areas:

1.		Procurement, including correspondence,
2.		Performance range paragraph.

(2) The test can also be checked in programmed form with questionnaires. In this case, ten tasks are to be carried out in each area.

(3) The tasks shall be carried out in such a way that they can normally be carried out in 150 minutes.

(4) The test shall be terminated after 180 minutes.

Practical examination

Audit work

§ 7. (1) The examination shall be carried out as a unit in writing and orally and shall relate to the processing of works-related orders.

(2) The written part has to be processed (by hand or computer) of work tasks in specified documents or forms and on the preparation of a concept (by hand or computer-based) for the presentation and further processing of the work orders in the oral part. The subjects covered shall relate to the purpose of the final examination and to the requirements of professional practice, taking into account the essential legal provisions and the relevant products, all of which shall be subject to the following: The following areas shall be considered:

1.		Procurement of goods, acceptance of goods and acceptance of goods,
2.		Goods storage and distribution,
3.		legal specificities of the medical device trade,
4.		Quality assurance and documentation.

(3) If the work is carried out on a computer-based basis, all essential steps must be taken into account for the examination board.

(4) The oral part shall be submitted before the entire examination board and shall extend from the written work to the presentation and further processing of the working tasks drawn up in writing. The examination is in the form of a conversation that is as lively as possible, with a call for discussion by means of the description of situations or problems.

(5) The written part shall last at least 45 minutes. In any case, it must be shut down after 60 minutes. The oral part shall last at least 15 minutes. He's to finish after 20 minutes. An extension of not more than ten minutes has to be done on a case-by-case basis, if the examination board is otherwise not able to assess the performance of the examination candidate.

Expert discussion

§ 8. (1) The expert interview shall be submitted before the entire examination board.

(2) The expert discussion has to be developed from the practical activity. The focus is on the examination of the professional qualification as well as the customer-and service-oriented ability to act of the examination candidate/candidate. This has to be done by guiding a conversation in a form that is as lively as possible, and with a call for discussion by means of signs of situations or problems.

(3) In the context of the task, all the following knowledge and skills shall be reviewed in an integrated way:

1.		Quality and use-related knowledge of the goods of the department,
2.		Category-specific characteristics of goods of the department,
3.		Customer information and customer advice,
4.		sales processing,
5.		the initiation of additional sales,
6.		Treatment of complaints,
7.		any occupational substantive legislation which is appropriate.

(4) The expert discussion should take 15 minutes for each candidate/candidate. An extension of not more than ten minutes has to be done on a case-by-case basis, if the examination board is otherwise not able to assess the performance of the examination candidate.

Repeat Review

§ 9. (1) The final examination of the Lehrabate can be repeated.

(2) In the case of the repetition of the examination, only the test items rated "not enough" shall be considered.

Evaluation

§ 10. The usefulness of the training in the teaching profession of medical device management is to be evaluated by using a vocational research institute. Until 30 June 2019, the Federal Vocational Training Advisory Board has issued an opinion (findings, motif report and conclusions) on the transfer of the medical device for medical products to the Federal Minister for Science, research and economy. In the event that an opinion is drawn up, no votes shall be taken into account in accordance with Section 31 (7) of the German Civil Law Judgment (BAG).

Entry into force and final provisions

§ 11. This Regulation shall enter into force 1. Jänner 2016 in force.

Mitterlehner