Medical Devices. CZECH REPUBLIC PRK Partners s.r.o. advokátní kancelář

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1 Medical Devices CZECH REPUBLIC PRK Partners s.r.o. advokátní kancelář CONTACT INFORMATION JUDr. Jan Kohout, partner Mgr. Monika Mašková, Life Sciences Coordinator PRK Partners s.r.o. advokátní kancelář Jáchymova 2, CZ PRAGUE 1 Tel.: jan.kohout@prkpartners.com monika.maskova@prkpartners.com 1. Definition of medical devices What is the definition of a medical device in your jurisdiction? In line with EU Directives a medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the necessary software for its proper application, intended by the manufacturer to be used for human beings for the purpose of - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, or - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. In addition to the above definition, there are certain products specifically mentioned as being subject to the legal regime of medical devices. These include devices intended for administration of medical products, devices containing a medicinal product (including medicinal products made of human blood or plasma) which supplement the effect of the

2 device, in vitro medical devices, custom-made medical devices, medical devices intended for clinical investigation, active implantable medical devices and accessories to medical devices. 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? The legal regime applicable to products incorporating both medicinal products (drugs/biologics) and medical devices depends on the main function of the product. If the main function of the combination product is pharmacological, immunological or metabolic, the product is subject to legal regime of medicinal products. However, if the main function is different (e.g. mechanical or electric), then the legal regime on medicinal devices applies. Specifically, combination products intended for one-time use are subject to the legal regime on medicinal products and, at the same time, legal regulations generally applicable to the technical requirements on products. ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? No. 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? Combination products regarded as medical devices (please see point i. above) are subject to the general legal regime governing the evaluation of medical devices. In addition, the legal regulation governing evaluation of drugs (mainly Act No. 378/2007 Coll., on Pharmaceutical Products, as amended) applies analogously to the evaluating of the drug component of the combination product. iv. What are the general conditions for review, approval and marketing the combination product? Generally, the conditions are the same as those for medical devices (for details please see Section 5 below). In addition, an expert statement regarding the safety and effectiveness of the drug component of the combination product must be issued by the competent authority, such as the European Medicines Agency ( EMEA ) or the State Institute for Drug Control ( SIDC ). 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 pre-review or a non-medical device? Yes. The key criteria for these differentiations derive from the legal definitions of medicinal products, medical devices and other types of products.

3 i. Are there any legal and binding criteria for determination whether the product is a medical device or medicinal product? Yes, the criteria derived from legal definitions of medicinal products and medical devices as well as certain other provisions of applicable laws and regulations are binding. Additional criteria that are non-binding can be found in incidental documents issued by competent regulatory authorities. ii. If the answer to (i) is positive, what are the main principles for differentiation? The key criteria for differentiation between medicinal products and medical devices are the product s main function and the main means of impact of the product. Supplementary non-binding criteria for differentiation between medicinal products and medical devices are listed in incidental documents and include the following: Proposed manner of use of the product including route of administration, recommended dosage and any restrictions on use, interaction, adverse effects, warnings, etc. Qualitative and quantitative composition of the product in relation to one unit of dose or pharmaceutical form, Proposed manner of use of the product including route of administration, Group of users, Proposed labelling and information for consumers, Information on matters relevant for the assessment of health risks associated with the product, Information on how the product is classified when placed on the market in other countries (classification in EU countries has priority). iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? No. Moreover, the influence of past court decisions is limited in the Czech legal system as they are not generally binding and thus influence the decision making of courts of lower instance only by means of persuasiveness. Instead of publishing administrative decisions the SIDC and the Ministry of Health issue non-binding guidelines describing basic principles for product differentiation. In case of doubt it is possible to submit to the SIDC an official request to determine whether the product in question falls into the category of medicinal products or not. It is also possible to informally consult with the SIDC. iv. How is software that may have some related-medical applications regulated in your jurisdiction? Software which itself forms a separate medical device is regarded as an active medical device and subject to the legal regulation of active medical devices. Software which forms an accessory to a medical device is also subject to the legal regime of medical devices, and as such it is classified separately from the main medical device.

4 Software which is only a component and integral part of a medical device is subject to legal regulations applicable to the respective medical device. 4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? Yes. The criteria for this differentiation derive from the legal definition of medical devices and certain other provisions of law governing medical devices. i. How are products composed of cells or animal/human tissue regulated in your jurisdiction? The handling of human cells and tissue is governed by a general legal framework (Act No. 296/2008 Coll., on Human Tissue and Cells, as amended). In addition, there are specialized categories of products containing human cells or tissue which are subject to different legal regimes. These are the legal regimes of medicinal products (Act No. 378/2007 Coll.), of transplantations (Act No. 285/2002 Coll.) and legal regime of medical devices (Act No. 123/2000 Coll.). The legal regime of medical devices also applies to medical devices containing animal tissue. ii. Are there any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product? Yes, the criteria derived from the legal definition of medicinal products as well as certain other provisions of the applicable laws and regulations are binding. iii. If the answer to (ii) is positive, what are the main principles for differentiation? The key differentiation principle is whether the product s main function complies with one or more of the functions listed in the definition of a medical device. iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? No. Moreover, the influence of past court decisions is limited in the Czech legal system as they are not generally binding and thus influence the decision making of courts of lower instance only by means of persuasiveness. Instead of publishing administrative decisions, the SIDC and the Ministry of Health issue non binding guidelines describing basic principles for product differentiation. In case of doubt it is possible to submit an official request to the SIDC to determine whether the product in question falls into the category of medicinal products or not. It is also possible to informally consult with the SIDC.

5 5. Admission to trade of medical devices What are the requirements for admission (import) of medical devices into trade? The main generally applicable requirements are (i) assessment of conformity of the device with technical requirements set out by Act No. 22/1997 Coll., on Technical Requirements on Products, as amended, and review of suitability of the device for providing health care by means of clinical assessment, (ii) the CE mark must be affixed to the device (except for custom made devices and devices intended for clinical trials), (iii) issue of written declaration on conformity of the device and (iv) notification is sent to the Ministry of Health. i. Is clinical assessment required for admitting (importing) medical devices into trade? Yes, except for in vitro medical devices and in specific cases where assessment of conformity based on clinical data is not suitable in such instances the conformity assessment is done based on an assessment of its function, comparative testing and preclinical assessment. ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? Clinical assessment can be conducted without clinical trials provided that it is justified to rely on existing clinical data. iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer s declaration of conformity sufficient? A manufacturer s declaration of conformity is sufficient for certain types of medical devices. 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? The manufacturer or its representative must notify to the Ministry of Health information relating to the certification of the medical device before the device is launched on the market. 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? No. The general legal regulation on data processing (Act No. 101/2000 Coll.) applies.

6 ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units? Specific rules apply to the processing of personal data by healthcare units in connection with the provision health care (Act No. 20/1966 Coll.). However, there is no specific regulation applicable to personal data sourced by means of medical devices containing software. iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? No. The general legal regulation on data processing (Act No. 101/2000 Coll.) applies. iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards? Adverse events must be reported using a prescribed form. The form and further details of the reporting are regulated by the Act on Medical Devices (Act No. 123/2000 Coll.) and a related regulation of the Ministry of Health (Regulation No. 501/2000 Coll.). Czech legal regulation requires only that the adverse event is reported to the responsible authority in the Czech Republic, i.e. the SIDC. The SIDC is responsible for transferring the information to authorities in other EU member states. 7. Reimbursement What is the optimal model of reimbursement of medical devices? Reimbursement of medical devices is currently being debated in the Czech Republic within the discussion on healthcare reform. Reimbursement based on a reference system which would provide reimbursement at an amount corresponding to that of other similar devices with comparable effects is among the most often discussed mechanisms. i. What are the rules of granting reimbursement of medical devices in your jurisdiction? Reimbursement of medical devices is regulated by the Act on Public Health Insurance (Act No. 48/1997 Coll.). Reimbursement generally applies to medical devices prescribed for the patient (i) to continue in the healing process, or (ii) to support stability of the patient s health situation, to distinctively improve the patient s health situation or to avoid its worsening, or (iii) to compensate or reduce the effects of a handicap including the replacement or modification of an anatomical structure or physiological process. The reimbursement amounts to 75% of the consumer price of the medical device. Reimbursement is provided for the basic and least expensive type of device in correlation to the extent and seriousness of the health handicap. 8. Distribution Is distribution and promotion of medical devices subject to legal regulation? Yes. In addition to general legal regulations on conducting business there are certain specific aspects of distribution of medical devices governed by the Act on Medical Devices (Act No. 123/2000 Coll.) and related legislation.

7 Promotion of medical devices is governed by the Act on Advertising (Act No. 40/1995 Coll.). i. Are there any specific regulations determining mode of business activity of medical devices distributors? The Act on Medical Devices (Act No. 123/2000 Coll.) sets out certain specific requirements, such as the obligation of the distributor to submit various notifications to the Ministry of Health and the SIDC. ii. Is administrative permit for medical devices distribution required? Distribution of medical devices requires a general trade license called Production, trade and services not included in Annexes 1 through 3 of the Act on Trades. In addition, the commencement of distribution of medical devices must be notified to the Ministry of Health. iii. Are there any specific limitations in distributing medical devices in your jurisdiction? The person who intends to place a medical device on the market in the Czech Republic in its own name is required to (i) have its seat or place of business in a member state of the European Union ( EU ) or (ii) appoint a single representative with a seat or place of business in an EU member state for all EU countries. In addition, there are various notification obligations connected with the distribution of medical devices. iv. Are obligations of distributors of medical devices specifically legally regulated? Yes, these obligations are set out in the Act on Medical Devices (Act No. 123/2000 Coll.) related legislation. v. What specific rules exist for advertising and promoting medical devices? Advertising and promoting medical devices is subject to the general legal on advertising (Act No. 40/1995 Coll.), without any specific rules. Specific rules apply only to presentations of medical devices for which a declaration on conformity was not issued. 9. Manufacturing How are manufacturing practices regulated? Manufacturing practices are regulated by secondary legislation implementing the Act on Medical Devices (Act No. 123/2000 Coll.). In addition, technical requirements are set out in technical norms developed and published by Czech Office for Standards, Metrology and Testing.

8 i. Are there any specific standards or regulations determining the quality of manufacturing practices? Yes. Governmental Regulation No. 336/2004 Coll., sets out requirements concerning design, construction and manufacturing of medical devices. In addition, criteria for overall quality management of medical devices production are set out in EN ISO13485:2003. ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced? Fulfillment of the respective requirements by the manufacturers is reviewed by authorized persons who issue certificates on compliance to the manufacturers. Compliance with applicable regulations is a part of the assessment of conformity for each type of medical device and a prerequisite for placing the device on the market. iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator? Yes. The manufacturer must submit the respective notification to the Ministry of Health. iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections? Yes. Inspections aimed at the manufacturing process are conducted by authorized persons established as non-governmental entities. The inspections include regular audits as well as inspections, which are not notified to the manufacturer in advance. 10. Regulatory Guidance How are the requirements communicated to medical device manufacturers? The requirements set out in legal regulations are published in the official Collection of Laws of the Czech Republic. Technical norms are published in the Bulletin of the Czech Office for Standards, Metrology and Testing. i. In what form do the laws and regulations appear that are applicable to medical device manufacturers? Legally binding regulations comprise laws, governmental regulations, notices and communications of the ministries. ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? Yes. Informal guidelines are issued by regulators, mainly by the Ministry of Health and the SIDC. The guidelines are published in bulletins issued by the regulators, which are also posted on their web sites.