gpg md ls czech republic

8/22/2019 GPG MD LS Czech Republic

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Copyright Lex Mundi Ltd. 2011

2100 West Loop South, Ste. 1000 Houston, Texas 77027 USA Tel: 1.713.626.9393 www.lexmundi.com

Medical Devices

CZECH REPUBLICPRK Partners s.r.o. advoktn kancel

CONTACT INFORMATION

JUDr. Jan Kohout, partner

Mgr. Monika Makov, Life Sciences CoordinatorPRK Partners s.r.o. advoktn kancel

Jchymova 2, CZ 110 00 PRAGUE 1Tel.: +420 - 221 430 111

Email:[email protected]@prkpartners.com

www.prkpartners.com

1. Definition of medical devicesWhat 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 thenecessary software for its proper application, intended by the manufacturer to be used forhuman beings for the purpose of- diagnosis, prevention, monitoring, treatment or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation of or compensation for an injury orhandicap,

- 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 itsfunction 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 foradministration of medical products, devices containing a medicinal product (including

medicinal products made of human blood or plasma) which supplement the effect of the
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device, in vitro medical devices, custom-made medical devices, medical devices intended forclinical investigation, active implantable medical devices and accessories to medical devices.

2. Combination productsi. 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 themain function of the combination product is pharmacological, immunological ormetabolic, the product is subject to legal regime of medicinal products. However, if themain 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 subjectto the legal regime on medicinal products and, at the same time, legal regulationsgenerally applicable to the technical requirements on products.

ii. Are combination products (combining drugs and medical devices) subject to separateregulation 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 subjectto the general legal regime governing the evaluation of medical devices. In addition, thelegal regulation governing evaluation of drugs (mainly Act No. 378/2007 Coll., on

Pharmaceutical Products, as amended) applies analogously to the evaluating of the drugcomponent of the combination product.

iv. What are the general conditions for review, approval and marketing the combinationproduct?

Generally, the conditions are the same as those for medical devices (for details please seeSection 5 below). In addition, an expert statement regarding the safety and effectivenessof the drug component of the combination product must be issued by the competentauthority, such as the European Medicines Agency (EMEA) or the State Institute for

Drug Control (SIDC).

3. Borderline productsAre there any official and binding criteria for determination whether the product is amedicinal 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 medicinalproducts, medical devices and other types of products.


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i. Are there any legal and binding criteria for determination whether the product is amedical device or medicinal product?

Yes, the criteria derived from legal definitions of medicinal products and medical devicesas 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 bycompetent 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 arethe products main function and the main means of impact of the product. Supplementary

non-binding criteria for differentiation between medicinal products and medical devicesare 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 ofproduct differentiation?

No. Moreover, the influence of past court decisions is limited in the Czech legal systemas they are not generally binding and thus influence the decision making of courts oflower 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 ofdoubt 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 possibleto informally consult with the SIDC.

iv. How is software that may have some related-medical applications regulated in yourjurisdiction?

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 regimeof medical devices, and as such it is classified separately from the main medical device.


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Software which is only a component and integral part of a medical device is subject tolegal regulations applicable to the respective medical device.

4. Cellular or tissue based productsAre 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 devicesand certain other provisions of law governing medical devices.

i. How are products composed of cells or animal/human tissue regulated in yourjurisdiction?

The handling of human cells and tissue is governed by a general legal framework (ActNo. 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 medicinalproducts (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 devicesalso applies to medical devices containing animal tissue.

ii. Are there any legal and binding criteria for determination whether the product is amedical device or cellular/tissue based product?

Yes, the criteria derived from the legal definition of medicinal products as well as certainother 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 products 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 ofproduct 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 oflower instance only by means of persuasiveness.

Instead of publishing administrative decisions, the SIDC and the Ministry of Health issuenon 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 possibleto informally consult with the SIDC.


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5. Admission to trade of medical devicesWhat are the requirements for admission (import) of medical devices into trade?

The main generally applicable requirements are (i) assessment of conformity of the devicewith 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 bymeans 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 writtendeclaration 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 ofconformity based on clinical data is not suitable in such instances the conformityassessment 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 basisfor clinical assessment?

Clinical assessment can be conducted without clinical trials provided that it is justified torely on existing clinical data.

iii. Is certification by an external certifying body required for compliance assessment ofmedical devices, or is a manufacturers declaration of conformity sufficient?

A manufacturers declaration of conformity is sufficient for certain types of medical

devices.

iv. Is administrative pre-clearance or pre-approval of medical devices required for admissionof medical devices into trade, or is post-launch notification sufficient?

The manufacturer or its representative must notify to the Ministry of Health informationrelating to the certification of the medical device before the device is launched on themarket.

6. Processing of personal data (privacy)What are the rules of processing of personal data in a number of activities performed bymanufacturer/s distributors/ healthcare units with the use of medical devices.

i. Are there any specific rules protecting the privacy of personal data of consumerspurchasing medical devices, by manufacturer/distributors?

No. The general legal regulation on data processing (Act No. 101/2000 Coll.) applies.


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ii. Are there any specific rules of processing of personal data sourced by means of medicaldevices containing software, by healthcare units?

Specific rules apply to the processing of personal data by healthcare units in connectionwith the provision health care (Act No. 20/1966 Coll.). However, there is no specificregulation applicable to personal data sourced by means of medical devices containingsoftware.

iii. Are there any specific rules of processing of personal data by manufacturers/distributorsin 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 foreigncountries 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 arelated 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 inthe Czech Republic, i.e. the SIDC. The SIDC is responsible for transferring theinformation to authorities in other EU member states.

7. ReimbursementWhat 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 whichwould provide reimbursement at an amount corresponding to that of other similar deviceswith 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 prescribedfor the patient (i) to continue in the healing process, or (ii) to support stability of the

patients health situation, to distinctively improve the patients health situation or to

avoid its worsening, or (iii) to compensate or reduce the effects of a handicap includingthe 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 correlationto the extent and seriousness of the health handicap.

8. DistributionIs 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.


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Promotion of medical devices is governed by the Act on Advertising (Act No. 40/1995Coll.).

i. Are there any specific regulations determining mode of business activity of medicaldevices distributors?

The Act on Medical Devices (Act No. 123/2000 Coll.) sets out certain specificrequirements, such as the obligation of the distributor to submit various notifications tothe 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, tradeand services not included in Annexes 1 through 3 of the Act on Trades. In addition, thecommencement of distribution of medical devices must be notified to the Ministry ofHealth.

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 inits 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 ofbusiness in an EU member state for all EU countries.

In addition, there are various notification obligations connected with the distribution ofmedical 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. ManufacturingHow 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 intechnical norms developed and published by Czech Office for Standards, Metrology andTesting.


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i. Are there any specific standards or regulations determining the quality of manufacturingpractices?

Yes. Governmental Regulation No. 336/2004 Coll., sets out requirements concerningdesign, construction and manufacturing of medical devices. In addition, criteria foroverall quality management of medical devices production are set out in ENISO13485:2003.

ii. If the answer to (i) is positive, how are these good manufacturing practices or qualitysystem 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 eachtype 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 authorizedbodies, 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 wellas inspections, which are not notified to the manufacturer in advance.

10.Regulatory GuidanceHow are the requirements communicated to medical device manufacturers?

The requirements set out in legal regulations are published in the official Collection of Lawsof the Czech Republic. Technical norms are published in the Bulletin of the Czech Office forStandards, Metrology and Testing.

i. In what form do the laws and regulations appear that are applicable to medical devicemanufacturers?

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 inwhat form?

Yes. Informal guidelines are issued by regulators, mainly by the Ministry of Health andthe SIDC. The guidelines are published in bulletins issued by the regulators, which arealso posted on their web sites.

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