Medicinal Products Law

Maintenance and periodic testing of medicinal products

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Extract from the Medicinal Products Law:

§ 85 (1) Medicinal products must be maintained under observation of the manufacturer's instructions by inspection, maintenance and overhauling and should be maintained professionally and in a traceable manner so that their functional efficiency and safety for patients, users and other parties are guaranteed for the entire duration of their life-time.
(2) Inspection, maintenance, overhauling and all tests associated with these may only be assigned to persons or organisations that are able to institute the respective necessary measures, based on their professional training and the experience gained from the practical work, as well as their knowledge (especially their knowledge of the applicable legal regulations and standards), who are able to recognise the possible consequences and risks and do their work in keeping with professional standards. They should not be subject to any directives when conducting and evaluating the tests.

(3) Public health facilities must take all necessary precautions for orderly maintenance of medicinal products.

§ 86. Overhauling of medicinal products must be followed by a test of the major constructional and functional features essential for their safety and functional efficiency to the extent that these may have been influenced by the overhauling procedure.


Periodic technical-safety testing of medicinal products

§ 87. Public health facilities must ensure that medicinal products included in a regulation pursuant to § 92 are periodically tested by a professionally qualified person or organisation.

§ 88. (1) Tests pursuant to § 87 must be conducted by taking into account the type of medicinal product to be tested and the manufacturer's data to an appropriate extent so as to be able to evaluate the safety and functional condition of the medicinal product. Accessories or combinations of products that might significantly influence the safety of the medicinal product must be taken into account.

(2) According to the ordinance pursuant to § 92, in the interest of the safety of patients, users and third parties, the Federal Minister of Labour, Social Affairs and Consumer Protection is obliged to designate the orderly condition of medicinal products of any type, group or class that must be subjected to periodic testing, and must establish the minimum requirements concerning the type, scope, performance and intervals of the periodic tests.



Kontakt:

Ing. Markus Elmer / Leader Technical Service
Schiller Handelsges.m.b.H.
Kampmüllerweg 24, A-4040 Linz
Tel.: +43 732 7099-14 / Fax +43 732 757000
markus.elmer@schiller.at