Medical Devices. AUSTRIA CHSH Cerha Hempel Spiegelfeld Hlawati

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1 Medical Devices AUSTRIA CHSH Cerha Hempel Spiegelfeld Hlawati CONTACT INFORMATION Thomas Zivny Stefan Huber CHSH Cerha Hempel Spiegelfeld Hlawati Parkring 2, A-1010 Wien +43/1/ Definition of medical devices What is the definition of a medical device in your Pursuant to Section 1 (1) of the Austrian Medical Devices Act (Medizinproduktegesetz, hereinafter: MPG), a medical device is any tool, instrument, machine or substance (including software which is required for the functioning of a medical device) for which the producers intend use on human beings for 1. detection, prevention, monitoring, treatment or relief of illnesses, 2. detection, monitoring, treatment, relief of injuries and handicaps 3. examination, modification or replacement of anatomic buildup or physiological events; 4. birth control and which have a main effect in or on the human body that cannot be reached by pharmacological or immunological nor metabolic means, even though their functioning can be supported by such means.

2 2. Combination products i. Which legal regime (on medicinal product or on medical devices) applies to combination products incorporating both medicinal products (drugs/biologics) and medical devices? Generally, under Section 5 (2) MPG the legal regime on medicinal products applies, but when authorities grant permits, the provisions of the MPG have to be respected as well. ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product? - iv. What are the general conditions for review, approval and marketing the combination product? Depending on the nature of the product, a clinical trial has to be undertaken in order to obtain a distribution permit. Marketing restrictions under the MPG apply. 3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring prereview or a non-medical device? i. Are there any legal and binding criteria for determination whether the product is a medical device or medicinal product? Yes, partly: If a medical device (with the exception of in-vitro-diagnostics) contains a product which taken apart would qualify as a medical device, the device qualifies as a medical device (Section 5 (3) MPG). ii. If the answer to (i) is positive, what are the main principles for differentiation? iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? Until now, the Austrian Supreme Court had to deal only in few cases with product differentiation and mainly referred to the wording of the law.

3 iv. How is software that may have some related-medical applications regulated in your Under Section 1 (1) MPG, also software required for purposes of a medical device qualifies as a medical device. Rules on medical devices apply. 4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is an animal or human based tissue or a medical device? There are no criteria. The MPG simply states that it does not apply to products based on human or animal tissues, with the exception of deadened animal tissues used for the production of medical devices. i. How are products composed of cells or animal/human tissue regulated in your To such products, the Tissue Safety Law (Gewebesicherheitsgesetz) applies. ii. Are there any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product? No. iii. If the answer to (ii) is positive, what are the main principles for differentiation? - iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? no. 5. Admission to trade of medical devices What are the requirements for admission (import) of medical devices into trade? As a general rule, medical devices have to be CE marked. Further, they have to be safe as described under several ordinances. i. Is clinical assessment required for admitting (importing) medical devices into trade? Not necessarily: Only for specific devices such testing may be prescribed by ordinance. ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? If such testing is prescribed, there is no alternative.

4 iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer s declaration of conformity sufficient? CE marking is required, which can only be obtained from independent testing institutions. iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient? CE marking (generally) is sufficient. If other criteria apply (clinical testing), they have to be fulfilled beforehand. 6. Processing of personal data (privacy) What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices. i. Are there any specific rules protecting the privacy of personal data of consumers purchasing medical devices, by manufacturer/distributors? General data protection rules apply. Moreover, Section 11 (4) MPG stipulates that privacy and human dignity have to be respected and that secrecy of personal data has to be assured. Under secs 110 et seq MPG, staff handling medical devices is obliged to respect privacy rights of the patients concerned. The same provisions contain an authorization for processing of data collected in the course of handling medical devices. ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units? Besides the ones stated in answer (i), no. iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? Besides the ones stated in answer (i), no. iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards? Section 70 MPG stipulates reporting duties of medical staff concerning all major incidents relating to medical devices. Reportings have to be filed with the Federal Ministry of Health. There are no specific reporting obligations concerning incidents in foreign countries. However, also the first importer of a medical device into the EU has to be notified of any incident (Section 70 (4) MPG). Since reporting duties bind the medical professions, reporting might also take place in case they learn of an incident that has occurred abroad.

5 7. Reimbursement What is the optimal model of reimbursement of medical devices? Copyright Lex Mundi Ltd Generally, medical devices are reimbursed if listed on a list established by the Austrian social security system and prescribed by a medical practitioner. If so, depending on the social insurance of the patient concerned, patients either receive the device without having to pay anything (or only a participation), or they have to pay for it and are reimbursed afterwards. i. What are the rules of granting reimbursement of medical devices in your Medical devices for which reimbursement can be obtained have to be listed by the social security system. 8. Distribution Is distribution and promotion of medical devices subject to legal regulation? i. Are there any specific regulations determining mode of business activity of medical devices distributors? Under the Austrian Trade Act (Gewerbeordnung), distributors have to apply for a trade licence for trade in medical devices and have to prove that they have certain knowledge in the relevant fields either by passing an exam or by demonstrating by other means (eg studies completed) that they avail over the required qualifications. See above. ii. Is administrative permit for medical devices distribution required? iii. Are there any specific limitations in distributing medical devices in your iv. Are obligations of distributors of medical devices specifically legally regulated? v. What specific rules exist for advertising and promoting medical devices? Promotion for medical devices that is misleading is forbidden (Section 102 (1) MPG). Moreover, promotion directed to consumers is forbidden for medical devices for which a prescription by a medical practitioner is required and which are designed to be used by medical staff only. Promotion directed to consumers has to be clearly marked as promotion and must contain basic indications as to producers, use and other specifications. Finally, promotion must not leave the impression that the product

6 concerned is better suited than another product or that treatment by a medical practitioner is not necessary. 9. Manufacturing How are manufacturing practices regulated? i. Are there any specific standards or regulations determining the quality of manufacturing practices? No, since the Austrian law rather looks at the device when finished (which then has to be safe). However, in order to get CE marking, adherence to certain production criteria such as standards might be required (depending on the product). ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced? ---- iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator? Any responsible person for the first importation of a medical device into the EU as well as an assembler of medical devices is obliged to register with the Federal Ministry of Health. iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections? The law confers general surveillance powers upon the authorities; it is up to their discretion whether they inspect establishments frequently. Authorities may ask for reports and other documentation as well as product samples, but may also make on site visits. Frequency of such visits and other surveillance measures may vary according to incidents reported and potential dangers resulting from the product in question. 10. Regulatory Guidance How are the requirements communicated to medical device manufacturers? i. In what form do the laws and regulations appear that are applicable to medical device manufacturers? All laws applicable in Austria can be found in the official database on the internet

7 ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? The Federal Ministry of Health ( iv_2010/oesterreichische_rechtsvorschriften_ueber_medizinprodukte) as well as the Austrian Economic Chamber (wko.at) publish information on their homepage. Most information on the website of the Austrian Economic Chamber is only available to its members.