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The Czech Republic is a member of the World Trade Organisation and is hoping to become a member of the European Union by the year 2003, having become an Associate Member in 1995. On its way to the EU, and in full incorporation with the Internal Market, the Czech government strengthened its efforts to speed up harmonisation of the Czech law with the EC law. As of July 1, 2000, a new law on medical devices becomes effective, which also regulates importation of medical devices to the Czech Republic. The law on medical devices is fully compatible with the EU legislation.

Full compatibility of the conformity assessment of selected products with the practise in the EU countries should already have been achieved prior to the Czech Republic acquiring full EU membership, particularly on the basis of implementing the Protocol to the European Agreement on European Conformity Assessment (PECA) between the Czech Republic and the EU. The proposal of PECA has been under preparation since 1998. The aim of PECA is to achieve free circulation between the Czech Republic and the EU products specified by this agreement prior to the admission of the Czech Republic to the EU.

Declaration of Conformity

The new act on medical devices replaces the system based on approval of medical devices by the State Institute of Drug Control with the assessment and declaration of conformity.

The same procedure and rules apply for the importation of new, used and refurbished medical equipment.

To import to the Czech Republic, a foreign producer must have an importer in the Czech Republic.

To release a medical device on the Czech market, the manufacturer or importer must arrange for assessment of conformity with essential requirements for medical devices. A manufacturer or importer issues a written Declaration of Conformity on compliance with technical requirements and abiding by the stipulated conformity assessment procedure. For the purposes of supervisory bodies, this declaration, together with documents on conformity assessment, must be maintained by the manufacturer or importer for ten years after termination of production or import.

In contrast to the practice applied in the EU countries, where products that have been assessed as to their conformity with the European Council directives bear the CE marking, in the Czech Republic, the Declaration of Conformity, issued by the producer or importer, is the proof of fulfilling the technical requirements and the conformity assessment procedure. This declaration, together with the assessment documents, should be kept on file by the producer or importer for a period of usually ten years from the time of termination of the production or importation for use by the control authorities. Besides this, the manufacturer or importer assures distributors of the products in writing that the declaration of conformity has been issued. Distributors are obliged to present the written assurance on issuance of declaration of conformity upon request to customers for inspection or provide a copy of such assurance. Providers must not use medical devices in health care provision if they have no copy of a written statement that a manufacturer or importer issued a declaration of conformity for the device.

A medical device must meet medical and technical requirements determined by the manufacturer for the whole period of its use in terms of health care provision. The intended purpose of use of a medical device must be stipulated in the declaration of conformity and in the instructions for use; it shall be also quoted on the medical device labelling and in advertising materials where technically feasible.

The manufacturer or importer or their authorised representative responsible for the first placing of a medical device on the market must have their place of residence or registered office in the Czech Republic. The name, surname and place of residence of a physical person, or the name (business name) and registered office of a legal person must be quoted in the instructions for use, and, where useful and feasible, also on its labelling; the place of business as well as the identification number of such a person must be quoted in the instructions for use.

The Government Orders 180/1998 and 130/1999 stipulate medical devices classification. According to this order, medical devices are divided into the I, IIa, IIb, and III classes according to their risk. The highest risk devices, including active implantabile sanitary medium medical devices, are included in the III class. Vast majority of devices are included in the I class.

For placing on the market a medical device from the I class, the manufacturer or importer makes an assessment of conformity himself. For placing on the market a medical device from the IIa, IIb, and III classes, the manufacturer or importer must arrange for conformity assessment by an authorised entity. Czech Office for Standardisation, Metrology and Testing publishes the list of the entities authorised to assess the conformity in the Bulletin (Vestnik).

The authorised body assesses the conformity with technical requirements and issues a certificate. The manufacturer or importer bares the costs of the conformity assessment.

The Declaration of Conformity must be in the Czech language and must include the following information:

1, identification data on the manufacturer or importer, who issued the Declaration of Conformity, including name, surname, place of residence, place of business activity and identification number if a physical person is concerned, or the name (business name), registered office, and identification number if a legal person is concerned

2, data on the medical device, i.e. name, type, mark, model, and identification data on the manufacturer in case of imported products

3, description of the medical device, its intended purpose of use, its classification, and further information upon manufacturer's or importer's decision

4, list of technical laws and Czech harmonised technical standards, used for the assessment of conformity and other legislation used

5, name (business name), registered office, and identification number of the authorised person, if it assessed the conformity, including the number and date of issuing of the certificate.

6, name, surname, place of residence, place of business activity and identification number of an accredited entity, if a physical person is concerned, or the name (business name), registered office and identification number if a legal person is concerned

7, date and place of issuing the declaration of conformity and names and positions of the responsible persons of manufacturer or importer and their signatures

8, declaration of manufacturer or importer assuring, that

- the nature of the medical device meets all basic requirements, technical laws and procedures, and

- the medical device is safe if used for the intended purpose under normal conditions

- the medical device is determined for single use or for repeated use under given hygienic conditions

- he/she has taken measures to ensure the conformity of all medical devices placed on the market with their technical documentation and with basic requirements

Labelling and Marking Requirements

Labelling must be in the Czech language. Information must include the name of the product, names of producer and importer, country of origin, and information necessary for the safe use of the medical device. Instructions for use are obligatory except for medical devices of class I and IIa unless instructions for use are necessary for safe use of the medical device. In addition, internatonal norms for warning labels apply. Czech importers/distributors are responsible for the correct labelling of products that are put on the Czech market, and can typically advise the U.S. exporter of specific requirements regarding labelling and marking.

Marking of the products with Czech Conformity Mark

For a medical device, for which the conformity must be assessed by the authorised entity, the producer or importer must provide a label of the Czech Conformity Mark (CCZ). The Czech Conformity Mark must be placed in a way that it is visible, legible and indelible and must be also quoted in the instructions for use. The Czech Conformity Mark must be accompanied (with the exception of medical devices of the I) by the identification number of the authorised entity, which assessed the conformity of given medical device.

Clinical investigation

The new law on medical devices introduces clinical investigation, which is compatible with the EU legislation. The law also stipulates, when clinical trial is necessary.

A medical device must be suitable for the use in health care provision; medical device suitability for the intended purpose of use must be verified, except for in vitro medical devices, by clinical investigation. Necessary clinical data shall be obtained from

the compilation of the relevant scientific literature available that corresponds to the time when the relevant clinical investigation is to be performed, and

the clinical trial results.

Clinical investigation, including a clinical trial, of a medical device means its systematic testing, while observing the intended purpose of use under conditions stated by the manufacturer performed according to a clinical investigation plan prepared in advance with an objective to

verify whether a medical device is suitable to be used in terms of health care provision, in particular with respect to its safety and efficiency (its benefits),

examine its effects on a subject of investigation,

specify undesirable side effects and to evaluate whether they represent acceptable risks.

If clinical data and experience related to a medical device, whose conformity should be assessed together with its suitability for the intended purpose of use, are sufficiently known and credibly documented in advance and in the necessary extent it is generally not necessary to perform clinical trials.

A clinical trial must be performed again if the intended purpose of use of the medical device is to be changed, and if a new intended purpose of use also requires performing a trial.

A clinical investigation plan means a document containing detailed information on the clinical investigation reasons, purpose, goals, proposed analyses, methodology and control. The plan must reflect the latest scientific and technical knowledge, and it must be designed in such a way that it would allow to confirm or refute data on the medical device declared by the investigation sponsor. The plan is binding regarding the medical device application and selection of a method of treatment for a person sponsoring the clinical investigation performance (sponsor), and for a clinical researcher (investigator), and, unless they withdraw from the clinical investigation, also for the subjects of investigation.

The sponsor is responsible for the commencement, management, organising, control or funding of such an investigation, and for the damage caused by a special nature of the medical device investigated.

The Ministry of Health, Section of Pharmaceutics, maintains a list of institutions competent to perform clinical investigation.

A provider qualified to perform clinical investigation establishes an independent ethics committee, which consists of health care professionals and has at least five members. The ethics committee grants a written consent to carry out clinical investigation of a medical device and performs surveillance of its course. The sponsor should ask the ethics committee in writing for consent to perform the clinical investigation and submit the necessary documentation. The ethics committee shall grant its approval or announce its disapproval of the clinical investigation performance within 60 days from the date of the request delivery.

Clinical investigation documentation

The clinical investigation documentation consist, in particular, of

prior to the clinical investigation commencement

1. a written contract between the sponsor and provider at whose premises the clinical investigation shall be carried out,

2. appropriate information known prior to the clinical investigation commencement (Investigator's manual),

3. a clinical investigation plan, prepared by the sponsor

4. written consent of the ethics committee,

5. a written agreement between the investigator (investigators) and the sponsor,

6. a written agreement between the sponsor, assistant to the sponsor and investigators that must contain, in particular, specification of their responsibility and provisions on keeping secrecy

7. a method of recovering damages in the case of causing harm to the health of the subjects of investigation as a result of their participation in the clinical investigation,

8. informed consent of the subjects of the investigation,

9. a set of documents containing necessary data on the subject of investigation and on the medical device to be investigated; these documents are a part to the clinical investigation plan,

10. the list of medicinal products and a method of administration to the subjects of investigation,

a) in the course of clinical investigation

records on activities performed according to the clinical investigation plan, on unforeseen events and measures adopted beyond the clinical investigation plan in the case of adverse incidents; the clinical investigation duration and frequency of examinations must correspond to the medical device characteristics, its intended purpose of use, its declared safety, suitability and efficiency in order to guarantee the validity of professional conclusions,

b) after its completion

a final report on clinical investigation.

The sponsor is obliged to ensure

an investigator who must

have adequate qualification, experience and knowledge on the use of the given medical device,

be authorised to perform the respective professional activity, and

know the clinical environment where the clinical investigation is to be performed as well as the conditions of and requirements for the clinical investigation,

a) the preparation, keeping, safety and completeness of documents, in particular

the clinical investigation plan,

reports on medical examinations of subjects of investigation,

consent of the ethics committee

information on adverse incidents that are reported to him,

final reports on clinical investigation,

other documents containing the data, statistical analyses, results of trials performed, including the data processed by the persons participating in the clinical investigation,

a) conclusion of written agreements

b) inform the investigators in writing of adverse incidents that take place in clinical investigations performed in several institutions within 10 days from the day when the sponsor was informed of them,

c) completion of the clinical investigation and handing the appropriate information over to the investigator.

Registration

The new law on medical devices introduces the system of registration of medical devices and their producers for information purposes.

Registration means an obligation of providers where clinical trials of medical devices are performed, manufacturers, importers and distributors of such devices who have their registered office in the Czech Republic and put them into service for the first time to notify the Ministry of the following before commencing their activity

type and scope of the performed activity,

date of the activity commencement

address of the activity performance location,

name, surname, place of residence and identification number if a physical person is concerned, or the name (business name), registered office, and identification number if a legal person is concerned,

data on the medical device:

name,

type,

intended purpose of use,

class,

date of issuing the declaration of conformity,

applied method of the conformity assessment.

a) data on authorisation based on which such an activity is performed,

b) method of the medical device dispensation if is determined

c) name, surname, place of residence, identification number of a physical person if concerned, or the name (business name), registered office, and identification number of a legal person if concerned who notifies the Ministry of the aforementioned data.

The manufacturers and importers having their registered office in the Czech Republic who place medical devices not requiring participation of authorised persons on the market in the Czech Republic are obliged to register such a product at the latest by the date of placing the medical device on the market. The registration must contain

the date of placing the medical device on the market, and

information on whether the medical device has a measuring function or not, and whether the medical device is sterile or non-sterile.

Contacts:

Ministry of Health of the Czech Republic

Palackeho nam. 4

128 01 Praha 1

Tel.: 420-2-2497-1111

Fax: 420-2-2497-2111

E-mail: mzcr@mzcr.cz

Http://www.mzcr.cz

- Section of Medical Devices

Contact persons: Mrs. Jirina Pavlikova

Mrs. Danuse Drahotova

Tel.: 420-2-2497-2363

Fax: 420-2-

- Section of International Relations

Contact person: Mrs. Blanka Jantaskova

Tel.: 420-2-2497-2468

Fax: 420-2-24915430

- Legislative Section

Contact person: Mr. Cermak

Tel.: 420-2-2497-2671

Fax: 420-2-2491-5985

US Embassy, Commercial Service

Trziste 15

118 01 Praha 1

Jana Ruckerova, Commercial Specialist

Tel: 00420-2-5753-1162

Fax: 00420-2-5753-1165

E-mail: Jana.Ruckerova@mail.doc.gov

Czech Office for Standardisation, Metrology and Testing

Urad pro technickou normalizaci, metrologii a statni zkusebnictvi

Biskupsky Dvur 5

110 02 Praha 1

Contact person: Mr. Miroslav Tesar, Deputy Chairman for Technical Normalisation

Tel.: 420-2-2180-2111

Fax: 420-2-232-4495

- Section of Metrology and Conformity Assessment

U Sovovych Mlynu 9

118 00 Praha 1

Contact person: Mr. Vojtech Petrik, Director

Tel.: 420-2-5753-3193

Fax: 420-2-530710

E-mail: Petrik@kampa.unmz.cz

Legal rules:

Act No. 123/2000 Coll. on medical devices

Act No. 22/1997 Coll. and 71/2000 Coll. on technical requirements on products

Governmental Order No. 180/1998 and 130/1999 on technical requirements on medical devices

Governmental Order No. 198/1999 on technical requirements on active implantabile sanitary medium medical devices