What is Act No. 375 / 2022 Coll.?

Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices — Law on in vitro medical devices and diagnostic medical devices.

When it became Act No. 375 / 2022 Coll. effectiveness?

Act No. 375 / 2022 Coll. became effective 22.12.2022.

Is Act No. 375 / 2022 Coll. still valid?

Yes, Act No. 375 / 2022 Coll. is still valid and effective.

How many times was it Act No. 375 / 2022 Coll. amended?

Act No. 375 / 2022 Coll. has 6 time versions of the text.

Act No. 375 / 2022 Coll. - Law on in vitro medical devices and diag...

375

THE LAW

of 3 November 2022

on in vitro medical devices and diagnostic medical devices

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

INTRODUCTORY PROVISIONS

§ 1

Subject matter

Regulation (EU) 2017 / 7451 of the European Parliament and of the Council ("the Regulation on medical devices') and Regulation (EU) 2017 / 7462 of the European Parliament and of the Council (" the Regulation on in vitro diagnostic medical devices')

(a) regulates the competence of administrative authorities in the exercise of government administration in the field of in vitro medical devices and diagnostic medical devices;

(b) complements the rules laid down in the Regulation on medical devices, the Regulation on in vitro diagnostic medical devices or the directly applicable European Union provisions adopted on the basis thereof;

(c) it regulates the information system of medical devices;

(d) it regulates the prescription and delivery of in vitro medical devices and diagnostic medical devices, their use and the conditions for their service.

§ 2

In vitro diagnostic medical devices and medical devices

(1) For the purposes of this Act, a medical device shall mean a medical device as referred to in Article 2 (1) of the Regulation on medical devices, medical device accessories as referred to in Article 2 (2) of the Regulation on medical devices and the product referred to in Annex XVI to the Regulation on medical devices.

(2) For the purposes of this Act, in vitro diagnostic medical devices are defined as in vitro diagnostic medical devices as referred to in Article 2 (2) of the Regulation on in vitro diagnostic medical devices or its accessories as referred to in Article 2 (4) of the in vitro diagnostic medical devices Regulation.

(3) For the purposes of this Act, a medical device and an in vitro diagnostic medical device are meant.

ČÁST DRUHÁ

PERFORMANCE OF STATE MANAGEMENT

§ 3

Government authorities

State administration in the area of resources

(a) the Ministry of Health ("the Ministry"),

(b) the State Institute for Drug Control (hereinafter referred to as the Institute);

(c) Office for Technical Standardisation, Metrology and State Testing.

§ 4

Ministry

Ministry of Resources

(a) cooperate with the competent authorities of the Member States of the European Union and other Contracting States of the Agreement on the European Economic Area (hereinafter referred to as "the Member State") and represent the Czech Republic in the working groups and committees of the European Union;

(b) appoint representatives of the Czech Republic to the Coordination Group for Medical Devices and its Subgroups pursuant to Article 103 of the Regulation on Medical Devices and Article 98 of the Regulation on in vitro diagnostic medical devices;

(c) decide on the exemption provided for in Article 64 (1);

(d) abolish the measure of the Constitution which the European Commission (hereinafter referred to as the Commission) has declared unjustified under Article 96 or 98 of the Regulation on medical devices or Article 91 or 93 of the Regulation on in vitro diagnostic medical devices;

(e) cooperate with other administrative authorities and notified bodies;

(f) proposes, in accordance with Regulation (EU) 2022 / 12324 of the European Parliament and of the Council ("the Regulation on enhanced role"), a representative of the Czech Republic to the Executive Management Group for the lack of medical resources established under Article 21 of the Regulation on enhanced role ("the Steering Group"),

(g) proposes representatives to a working group established under Article 25 (1) of the Regulation on enhanced role and is a single point of contact in relation to the lack of resources within the meaning of the second subparagraph of Article 21 (5) of the Regulation on enhanced role;

(h) submit a request to the Steering Group for the provision of aggregated data and demand forecasts in accordance with Article 24 (2) of the enhanced role Regulation; and

(i) take into account the recommendations of the Steering Group adopted pursuant to Article 24 (3) or (4) of the Regulation on enhanced role or guidelines and recommendations adopted by the European Commission pursuant to Article 28 (b) of the Regulation on enhanced role and coordinate its activities in this field with the competent authorities of other Member States.

Institute

§ 5

(1) The Institute shall exercise the powers conferred on a Member State or the competent authority of a Member State by a Regulation on medical devices or a Regulation on in vitro diagnostic medical devices or directly applicable European Union provisions adopted pursuant thereto, unless otherwise provided for in that law and in so far as they are not applicable in the field of notified bodies under Article 35 to 58 of the Regulation on medical devices or Article 31 to 53 of the Regulation on in vitro diagnostic medical devices, the exercise of which falls under another legislative act (3). Office for Technical Standardisation, Metrology and State Testing.

(2) Furthermore, the Institute in the area of resources in particular:

(a) represents the Czech Republic in the working groups and committees of the European Union within its competence;

(b) cooperate with the Office for Technical Standardisation, Metrology and State Testing and the competent authorities of foreign States, Member States and the European Union within its scope;

(c) accept the notification of producers of custom-made medical devices, distributors and persons performing their service;

(d) establish, manage and operate an information system for medical devices;

(e) decide on:

1. restriction and suspension of the making available on the market of the device;

2. the measures referred to in Articles 95 (1) and 98 (1) of the Regulation on medical devices or Articles 90 (1) and 93 (1) of the Regulation on in vitro diagnostic medical devices;

3. measures pursuant to the Commission Implementing Regulation pursuant to Articles 59 (3) and 96 (3) and 98 (4) of the Regulation on medical devices or Articles 54 (3) and 91 (3) and 93 (4) of the in vitro diagnostic medical devices Regulation;

4. withdrawal of the device from the market;

5. Withdrawal of the device,

6. the restriction or termination of the use of the device,

(f) decide whether the product falls within the scope of the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices;

(g) decide on the exemption provided for in Article 64 (2);

(h) carry out market surveillance in accordance with the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices, this Act and the Act on conformity assessment of specified products when supplied to the market (4);

(i) checks compliance with this law, the Regulation on medical devices, the Regulation on in vitro diagnostic medical devices and the directly applicable European Union provisions adopted pursuant to the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices;

(j) issue free sales certificates;

(k) decide at first instance on infringements under this law;

(l) conduct an educational activity;

(m) draw up expert opinions upon request and provide expert consultations;

(n) adopt measures pursuant to Article 87 (10) of the Regulation on medical devices or Article 82 (10) of the Regulation on in vitro diagnostic medical devices;

(o) keeps and publishes a list of ethics committees established by health service providers and announced institutes pursuant to Article 13 (1);

(p) submit an application pursuant to Article 4 (1) of the Regulation on medical devices or Article 3 (1) of the Regulation on in vitro diagnostic medical devices;

(q) issue measures pursuant to Article 6 (3);

(r) establish, manage and operate a central repository of electronic vouchers as part of the electronic recipe information system under the drug law (hereinafter referred to as the eRecept system);

(s) publish on its website a list of senators who have access to eRecept for the purpose of issuing the funds prescribed for the voucher pursuant to Article 28 (1) (a);

(t) cooperate with the European Medicines Agency in the performance of its task under Article 25 (1) (b) of the Regulation on enhanced role in the development of information systems and ensure the fulfilment of the obligations of the Czech Republic under Article 27 of the Regulation on enhanced role;

(u) take into account the recommendations of the Steering Group adopted pursuant to Article 24 (3) or (4) of the Regulation on enhanced role or the guidelines and recommendations adopted by the European Commission pursuant to Article 28 (b) of the Regulation on enhanced role and coordinate its activities in this area with the competent authorities of other Member States;

(v) inform the Steering Group in accordance with the second subparagraph of Article 22 (1) and Article 27 (4) (c) of the Regulation on the enhanced role; and

(w) pursuant to Article 27 (2) of the Regulation on enhanced role from manufacturers, authorised representatives, notified bodies, importers, distributors and health service providers, require further information concerning the production and supply problems faced by those persons in the area of resources.

(3) Furthermore, in accordance with Article 6 (4) of the Regulation on medical devices or Article 6 (4) of the Regulation on in vitro diagnostic medical devices, in order to protect public health, the Institute may request the providers of information society services to cease this activity because of a breach of the obligations under the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices. In the event that the information society service provider fails to complete its activities no later than 30 days after the date of receipt of the request under the first sentence, the Institute shall issue a decision prohibiting the information society service provider from carrying out that activity. The prohibition of action shall be imposed by the Institute only to the extent that the performance of the Institute is in breach of the obligations arising from the medical devices regulation or the in vitro diagnostic medical devices regulation. The decision of the Constitution is the first act in the proceedings and the appeal against it does not have suspensory effect. Documents shall be served in the proceedings by a public order; The Institute shall, at the same time as the public order is issued, send a document to the information society service provider in a manner which would otherwise be served under the administrative rules. The document shall be deemed to have been delivered on the fifth day following the publication of the public order.

§ 6

(1) In case of doubt, the Institute will decide whether the product falls within the scope of the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices on request or ex officio. Where the decision of the Institute, in accordance with the first sentence of Article 4 of the Regulation on medical devices or Article 3 of the Regulation on in vitro diagnostic medical devices, is legally applicable, the Institute shall immediately, after the application of such implementing regulation, initiate an ex officio procedure to revoke the decision in accordance with the first sentence of Article 4 of the Regulation on in vitro diagnostic medical devices if that decision is contrary to that implementing regulation. The first act in the procedure for the annulment of a decision under the first sentence shall be the adoption of a decision; the appeal against the decision in the annulment procedure under the first sentence shall not have suspensory effect.

(2) If, on the basis of the available supporting documents, the Institute cannot take a decision under the first sentence of paragraph 1, it shall submit an application under Article 4 (1) of the Regulation on medical devices or under Article 3 (1) of the Regulation on in vitro diagnostic medical devices and shall suspend the procedure under the first sentence of paragraph 1.

(3) The Institute shall issue a general measure limiting the production or use of a particular type of device pursuant to Article 5 (5) of the Regulation on medical devices or Article 5 (5) of the Regulation on in vitro diagnostic medical devices where it finds that its use poses a risk to the safety of patients, users or others or to public health.

(4) When issuing measures of a general nature pursuant to paragraph 3, a draft measure of a general nature shall be served and the measure of a general nature notified by a public decree on the official plate of the Constitution.

(5) A measure of a general nature as referred to in paragraph 3 shall take effect on the 15th day following its publication on the official plate of the Constitution. The Institute may, in cases which cannot be delayed, determine the earlier beginning of the measures of a general nature, but first at the time of the hanging.

§ 7

Information system for medical devices

(1) The Institute is the founder, administrator and operator of the Information System of Medical Devices, which is not publicly available, unless otherwise provided by law. The information system of medical devices is a public administration information system intended in particular for the collection and management of data and for the submission of declarations and requests by the Institute and, in the cases provided for by law, to inform the public. Where the Information System of Medical Devices does not serve to inform the public, access to it is only possible with a guaranteed identity. The Information System of Medical Devices contains in particular the data obtained by the Institute

(a) electronic systems under the Regulation on medical devices or under the Regulation on in vitro diagnostic medical devices;

(b) pursuant to Articles 8, 10, 13 and 23 and Article 16 (4) of the Regulation on medical devices or Article 16 (4) of the Regulation on in vitro diagnostic medical devices.

(2) The information referred to in Article 33 of the Regulation on medical devices, information referred to in Article 30 of the Regulation on in vitro diagnostic medical devices, data on persons who have reported their activities pursuant to § 23 and data on the means concerned reported pursuant to § 23 (2) (e) and (f) shall be published through the Health Device Information System.

(3) At the request of the manufacturer, the Institute will remove the link between the manufacturer and the person performing the service in the Health Device Information System.

(4) The information referred to in Article 16 (4) of the Regulation on medical devices or in Article 16 (4) of the Regulation on in vitro diagnostic medical devices is provided by distributors or importers of the Institute through the Information System on Medical Devices.

(5) Other persons may be authorised to conduct operations in the Information System of Medical Devices under this or other law. The power of attorney may only be granted and accepted by the agent by means of an electronic form available through the Information System of Medical Devices.

ČÁST TŘETÍ

OBLIGATIONS OF THE MANUFACTURER, REVIEW FOR ONE USE, FREE SALE CERTIFICATE

§ 8

Obligations of the manufacturer and his authorised representative

(1) The manufacturer or his authorised representative, who has his registered office in the Czech Republic or who places or supplies the device on the market in the Czech Republic, is obliged to keep and submit to the Institute on request all information and documentation necessary to demonstrate the conformity of the device in the Czech, Slovak or English language. The manufacturer shall ensure that the declaration of conformity referred to in Article 19 (1) of the Regulation on medical devices or in Article 17 (1) of the Regulation on in vitro diagnostic medical devices is issued in the Czech, Slovak or English language in the case of a device made available on the market in the Czech Republic or in one of these languages.

(2) The manufacturer who places or supplies the device on the market in the territory of the Czech Republic is obliged to provide the information referred to in Article 10 (11) of the Regulation on medical devices or in Article 10 (10) of the Regulation on in vitro diagnostic medical devices, the information referred to in Article 18 (1) (a) to (d) of the Regulation on medical devices, the information referred to in Article 89 (8) of the Regulation on medical devices or referred to in Article 84 (8) of the Regulation on in vitro diagnostic medical devices and the declaration referred to in Annex XIII (1) to the Regulation on medical devices in the Czech language.

(3) If the manufacturer or his authorised representative fails to comply with the obligation referred to in the first sentence of Article 31 (5) of the first Regulation on medical devices or the obligation referred to in the first sentence of Article 28 (5) of the first Regulation on in vitro diagnostic medical devices, the Institute may, in accordance with the second sentence of Article 31 (5) of the second Regulation on medical devices or in accordance with the second sentence of Article 28 (5) of the second Regulation on in vitro diagnostic medical devices, decide to suspend the placing on the market of the device in the Czech Republic.

(4) The manufacturer of a medical device which has its registered office in the Czech Republic is obliged to provide the Institute through the Information System of Medical Devices

(a) the start-up information within 30 days of the start of production of the medical device;

(b) a list of generic groups of manufactured medical devices made available on the market within the territory of the Czech Republic within 6 months of the start of production of custom medical devices;

(c) information on termination.

(5) The manufacturer of a medical device is obliged to submit, upon request by the Institute, a list of medical devices which he has made available on the market in the Czech Republic, but for a maximum period of 10 years and for implantable devices for a period of 15 years preceding the date of such request by the Institute.

(6) The Institute shall assign a registration number to each manufacturer of a medical device that has notified the commencement of operations referred to in paragraph 4 through the Information System of Medical Devices.

(7) Where a manufacturer infringes the obligations referred to in the second subparagraph of Article 10 (14) of the Regulation on medical devices or the second subparagraph of Article 10 (13) of the Regulation on in vitro diagnostic medical devices, the Institute shall without delay take appropriate restrictive or prohibiting measures to ensure the protection of public health and the safety of patients. The Institute shall take the measures referred to in the first sentence until the manufacturer has cooperated with the Institute or until the Institute has provided the complete and correct information referred to in the first subparagraph of Article 10 (14) of the Regulation on medical devices or the first subparagraph of Article 10 (13) of the Regulation on in vitro diagnostic medical devices. The measures referred to in the first sentence shall be decided by the Institute. The appeal against this decision shall not have suspensory effect. The measures under the first sentence are:

(a) suspension or restriction of the making available on the market of a device;

(b) withdrawal of the device from the market; or

(c) recall of the device.

§ 9

Single-use recovery

(1) The implementation of the renewal of the disposable device is prohibited in the Czech Republic.

(2) The placing on the market and the making available on the market and use of a renewed device for single use in the Czech Republic shall be prohibited.

§ 10

Issue of a free sale certificate

(1) The applicant submits an application for a certificate of free sale to the Institute through the Information System of Medical Devices.

(2) The application must contain, in addition to the formalities laid down in the rules of procedure:

(a) the primary identifier of the device model (basic UDI-DI) in the UDI system in accordance with Article 27 of the Regulation on medical devices or Article 24 of the Regulation on in vitro diagnostic medical devices, if assigned; and

(b) whether a certificate of free sale is required in electronic or paper form.

(3) The Institute will verify in the European Health Device Database (Eudamed database) that the device is registered and that there has been no change since the date of the marketing authorisation which would prevent the issuance of the free-sale certificate.

(4) The Institute shall issue a certificate of free sale in Czech and English in accordance with Article 60 of the Regulation on medical devices or in accordance with Article 55 of the Regulation on in vitro diagnostic medical devices to the applicant by means of a certificate under the Administrative Rules or reject the application.

(5) For the purpose of issuing the free-sale certificate referred to in paragraph 4, the applicant shall also comply with the conditions laid down in Article 29 (4) of the medical devices Regulation or Article 26 (3) of the in vitro diagnostic medical devices Regulation.

(6) An application for a free sale certificate may be submitted for a single device or for a group of devices belonging to the same generic group.

ČÁST ČTVRTÁ

CLINICAL ASSESSMENT AND CLINICAL TESTS, EVALUATION OF FUNCTION ELIGIBILITY AND FUNCTION ELIGIBILITY STUDY

Ethics Committee

§ 11

(1) The Ethics Committee carries out an independent ethical review of the clinical trial or ethical review of the performance study in order to assess, with an emphasis on ethical aspects, whether the rights, safety, dignity and quality of life of the subjects of the clinical trial or of the performance study are protected and whether these aspects prevail over all other interests.

(2) The Ethics Committee shall give a written opinion on the intention to carry out a clinical trial or a performance study and shall supervise their conduct with regard to the objectives referred to in paragraph 1. To this end, it shall, in particular, examine the competence of examiners, including the principal examiner, and the suitability of the selected procedures and groups of subjects of the clinical trial or of the groups of entities of the performance study, and shall express its opinion on the clinical trial or performance study protocol and on the documents used to inform the subjects of the clinical trial or performance study and obtain their informed consent, independently of the sponsor of the clinical trial or performance study and the investigator.

(3) The Ethics Panel shall supervise the conduct of a clinical trial or a performance study on which it has delivered an opinion, at intervals appropriate to the degree of risk for the subjects of the clinical trial or performance study, but at least once a year, in accordance with paragraph 1 and with the procedures laid down in Article 13 (2). If, at the date of the death of the Ethics Committee during a clinical trial or a performance study, its activity does not exceed that of another Ethics Committee, the opinion of the Ethics Committee shall cease to be in agreement with the conduct of the clinical trial or validity study.

§ 12

(1) The Ethics Commission is established by the health service provider. The Ethics Commission may also act as the Ethics Committee of another health service provider, on the basis of a written contract concluded between health service providers. In such a case, the health service provider who established it shall ensure the conditions for the activities of the Ethics Commission.

(2) The health service provider shall appoint members of the Ethics Commission in writing and with their consent. The Ethics Committee shall consist of at least five members. At least 1 of the members of the Ethics Commission must be a person without a medical education and without a professional scientific qualification in the field of health, and at least 1 of the members of the Ethics Committee must be a person who is not in a professional relationship, another similar employment relationship or another dependant to the provider of health services which is established by the Ethics Commission or who operates a medical establishment in which the proposed clinical trial or performance study will take place, and must be two distinct members of the Ethics Committee. At least 4 members of the Ethics Commission must have an education of a physician, dental practitioner, pharmacist or non-medical medical professional under another legislation governing the competence of a medical practitioner, dental practitioner and pharmacist or non-medical medical practitioner, and at least 3 members of the Ethics Committee must have an education of a doctor, dentist or pharmacist and at least 5 years of experience in their field. A health service provider setting up an Ethics Commission shall seek consent from individual candidates to be members of an Ethics Committee and shall instruct them on the duties of a Ethics Committee member under paragraph 4; candidates to be members of an Ethics Committee shall confirm in writing that they agree to their membership of the Ethics Commission and that they have been informed of the duties of a Ethics Committee member under paragraph 4. The members of the Ethics Commission shall elect the Chairman of the Ethics Commission from among their number. In order to obtain an opinion on a specific request for an opinion, the Ethics Committee may invite other experts; paragraph 4 shall apply mutatis mutandis to such invited experts.

(3) Only an upstanding person older than 18 years of age whose competence has not been restricted may be a member of the Ethics Committee. A natural person meeting the conditions of integrity under another legislation governing the fitness to pursue the profession of medical practitioner, dental practitioner and pharmacist or non-medical medical practitioner shall be deemed to be fit. The integrity of the natural person shall be demonstrated by an extract from the record of the Register of Penalties in accordance with another law governing the Register of Penalties and by evidence of the corresponding extract from the record of the Register of Penalties issued by the State of which the natural person is a citizen, as well as by appropriate documents issued by States in whose territory the natural person has remained continuously for more than 6 months in the last 3 years. An extract from the Register of Penalties and documents proving the integrity of a natural person shall not be more than 3 months old. If the State referred to in the sentence does not issue a third extract of the criminal record or an equivalent document, or if it is not able to obtain it, the natural person shall submit a declaration of integrity which he has made before the notary or the competent authority of that State. A stranger who is, or has been, a national of another Member State of the European Union, or has or has had an address in another Member State of the European Union, may, instead of an extract from a register similar to the Register of Penalties, provide proof of integrity with an extract from the Register of Penalties with an annex containing the information entered in the criminal record of another Member State of the European Union.

(4) A member of the Ethics Committee is obliged to:

(a) maintain confidentiality regarding the information and facts relating to the course of the clinical trial or performance study, in particular the health status of the subjects of the clinical trial or performance study and the results of the clinical trial or performance study which they learn in connection with their membership of the Ethics Committee;

(b) notify without delay the personal interest in the clinical trial or performance study under consideration or, where appropriate, the appearance of such interest;

(c) refrain from making comments on requests for consent to carry out a clinical trial or to carry out a performance study of his or her personal interest in the conduct of which he or she has a personal interest, as well as the professional supervision of such a clinical trial or performance study.

(5) Membership of the Ethics Commission is no longer established

(a) surrender as a member of the Ethics Commission;

(b) the death of a member of the Ethics Commission; or

(c) if a member of the Ethics Committee no longer fulfils the conditions of membership under paragraphs 2 to 4.

(6) The Ethics Committee shall cease to exist if:

(a) the composition of its members does not fulfil the conditions laid down in paragraph 2;

(b) the health service provider which established it has decided on its demise;

(c) the provider of the health services that established it has interrupted the provision of health services; or

(d) the health service provider which established it;

1. authorisation to provide health services is suspended;

2. the authorisation to provide health services is withdrawn; or

3. the authorisation to provide health services has expired.

§ 13

(1) The health service provider shall report to the Institute, through the Information System of Medical Devices, the setting up and demise of the Ethics Committee and the change in its composition without undue delay, but not later than 30 days after the date of its establishment or its demise or change in its composition. The information on the demise of the Ethics Commission shall also be communicated by the health service provider to all procuring entities of clinical trials or performance studies for which the Ethics Committee is supervised without undue delay, but no later than 5 working days after the date of its demise. The report shall include the name of the Ethics Commission, the contact address, the telephone number for the public telephone network and the e-mail address, the names and surnames of the members of the Ethics Commission, indicating the professional orientation of the members of the Ethics Commission, the name and surname of the Chairman of the Ethics Commission and the date of establishment, changes in the composition or demise of the Ethics Commission.

(2) The Ethics Committee shall carry out its activities in accordance with written working procedures to be developed for this purpose. Written working procedures shall be approved by all members of the Ethics Commission. The procedures for examining requests for an opinion on a clinical trial or on a study of performance and supervision of the course of a clinical trial or a performance study shall be compatible with the procedures for examining the application for authorisation of a clinical trial laid down in the Regulation on medical devices in the case of diagnostic medical devices in vitro, shall be compatible with the procedures for examining the application for authorisation of a performance study established by the Regulation on in vitro diagnostic medical devices and shall include at least:

(a) information on the composition of the Ethics Commission, in the scope of the names and surnames of the members and their qualifications, data on the medical establishment for which it is established by the health service provider;

(b) the methods and procedures for examining requests for the opinion of the Ethics Committee on the clinical trial or on the performance study and for carrying out the ongoing supervision of the clinical trial or the performance study, including the way in which the meetings are planned and notified to the members of the Ethics Committee and the way in which they are conducted;

(c) procedures for rapid assessment and opinion on administrative changes in the ongoing clinical trial or in the ongoing performance study;

(d) the methods of processing the reports of examiners and information obtained from the supervision of the clinical trial or the performance study or otherwise;

(e) the procedure for issuing the opinion on the clinical trial or on the performance study and its communication to the examiner or health service provider, the procedures for reviewing the opinion and withdrawing the opinion; and

(f) the procedures for fulfilling the information obligations laid down by law.

(3) The health service provider shall keep all records of the activities of the Ethics Committee set up for at least 10 years after the end of the clinical trial or performance study.

(4) In the event of the disappearance of the Ethics Commission, the provider of health services established by the Ethics Commission shall notify the Institute of whether another Ethics Committee is taking over the activities of the extinct Ethics Commission. At the same time, the Institute shall communicate the list of ongoing clinical trials or performance studies supervised by the repealed Ethics Committee and shall indicate how the retention and transmission of a copy of the documentation to another Ethics Commission is ensured.

(5) In the absence of supervision by another Ethics Committee, the ongoing clinical trial or performance study of a given health service provider shall be suspended until another Ethics Committee takes over the supervision of the clinical trial or performance study. The procuring entity of the clinical trial concerned or the performance study concerned shall ensure the suspension of the recruitment of new subjects of the clinical trial or performance study and the continuation of the monitoring of already included clinical trial or performance study entities in accordance with the clinical trial plan or performance study plan.

(6) The Institute maintains and publishes through the Information System of Medical Devices a list of Ethics Committees in the Czech Republic, indicating in particular the name of the Ethics Commission, the contact addresses of the Ethics Commission, the professional orientation of its members, the dates of setting up the Ethics Commission, or the dates of the demise of the Ethics Commission.

Procedure for issuing the opinion of the Ethics Commission

§ 14

(1) Where a clinical trial or a performance study has been conducted in a health facility for which a consensus opinion has been given by the Ethics Committee established by the health service provider operating that health facility, the management of the healthcare facility shall create the conditions for that Ethics Committee to carry out its activities throughout the duration of the clinical trial or performance study in that healthcare facility and, if changes occur in its composition, to ensure the continuity of its activities and its rights and obligations.

(2) The Ethics Committee shall, at the request of the contracting entity, give an opinion on the clinical trial or performance study. The contracting authority shall pay the provider of the health services which it has set up for the Ethics Commission the reimbursement of the expenditure effectively incurred by it in the context of the issue of this opinion.

(3) The Ethics Committee shall give its opinion on the clinical trial or on the performance study at a meeting which it shall declare in advance in accordance with the working procedures referred to in Article 13 (2). The Ethics Commission shall have a quorum if at least five of its members participate in it, of which 1 must be a person without a medical education and with no professional scientific qualifications in the field of health and at least 4 must have an education of a doctor, dental practitioner, pharmacist or non-medical healthcare professional under another law governing the medical profession of a doctor, dentist and pharmacist or non-medical healthcare professional, and at least 1 of the members with a medical education must be a person who is not in employment, other equivalent employment relationship or other dependent status to a health service provider established by the Ethical Commission or operating a medical institution in which will be the proposed clinical trial or performance study. The Ethics Commission shall act by an absolute majority of the members present who may vote in accordance with the fifth and sixth sentences. In the event of a tie, the chairman shall vote. Only those members of the Ethics Commission who have participated in the discussion of a specific request for an opinion throughout the whole period may vote. If the examiner is also a member of the Ethics Committee in the relevant clinical trial or performance study, he shall be excluded from the examination of the application.

(4) The Ethics Commission is required to make minutes of the negotiations. The minutes of the meetings of the Ethics Commission shall contain the date, hour and place of the hearing, the list of the members of the Ethics Committee present, the list of other persons invited, the main points of the discussion, the opinion adopted, including the record of the outcome of the vote on this opinion, indicating how the members of the Ethics Committee voted, the record of the notification of the possibility of conflicts of interest of the Ethics Committee members and the signature of at least 2 members of the Ethics Commission.

§ 15

(1) In the case of medical devices, when preparing its opinion, the Ethics Panel shall assess, in accordance with the ethical principles and methods set out in Chapter I of Annex XV to the Regulation on medical devices, whether the conditions laid down in Article 62 (4) (d) to (k) of the Regulation on medical devices are met, and

(a) assess the justification of the clinical trial and its organisation;

(b) assess whether the assessment of the expected benefits and risks is acceptable and whether its conclusions are justified;

(c) assess the clinical trial plan drawn up in accordance with point 3 of Chapter II of Annex XV to the Regulation on medical devices;

(d) assess whether the examiners and their collaborators comply with the requirements of Article 62 (6) of the Health Devices Regulation;

(e) assess the investigator's information set, drawn up in accordance with Annex XV, Chapter II, point 2, to the medical devices Regulation;

(f) assess whether the facilities of the health service provider in which the clinical trial is to be conducted comply with the requirements of Article 62 (7) of the Health Device Regulation;

(g) in the case of a clinical trial, assess whether the information provided under Article 63 (2) of the Regulation on medical devices corresponds to the ability of such persons to understand such information;

(h) assess whether the compensation of the subjects of the clinical trial in the event of injury resulting from the clinical trial is adequately ensured, in particular, assess all indemnity insurance concluded pursuant to Article 19 (1);

(i) assess the way in which the subjects of the clinical trial are recruited;

(j) assess the text of the informed consent and other written information provided to the subjects of the clinical trial.

(2) In the case of in vitro diagnostic medical devices, when preparing its opinion, the Ethics Panel shall assess, in accordance with the ethical principles and methods set out in Annex XIV to the in vitro diagnostic medical devices Regulation, whether the conditions laid down in Article 58 (5) (d) to (k) of the in vitro diagnostic medical devices Regulation are met, and

(a) assess the justification of the performance study and its organisation;

(b) assess whether the assessment of the expected benefits and risks is acceptable and whether its conclusions are justified;

(c) assess the performance study plan drawn up in accordance with Annex XIV, Part A to the in vitro diagnostic medical devices Regulation;

(d) assess whether the examiners and their collaborators comply with the requirements of Article 58 (7) of the Regulation on in vitro diagnostic medical devices;

(e) assess a set of information for the examiner, drawn up in accordance with Annex XIV, Chapter I, point 2 of the in vitro diagnostic medical devices Regulation;

(f) assess whether the facilities of the health service provider in which the performance study is to be carried out comply with the requirements of Article 58 (8) of the in vitro diagnostic medical devices Regulation;

(g) assess, in the case of a performance study, the conditions for carrying out the performance study in accordance with Article 60 (1) of the in vitro diagnostic medical devices Regulation,

(h) assess whether the compensation of the entities of the performance study in the event of injury arising from the performance study is adequately ensured, in particular, assess all injury indemnity insurance, concluded in accordance with Article 19 (1);

(i) assess the way in which the subjects of the performance study are recruited;

(j) assess the text of the informed consent and other written information provided to the entities of the performance study.

(3) When assessing refunds and insurance, the Ethics Committee shall always assess whether:

(a) the compensation of the subject of the clinical trial or of the injury performance study resulting from his participation in the clinical trial or of the performance study is adequately secured by the insurance contract referred to in Article 19 (1);

(b) the obligation to make good the damage to the investigator and the contracting entity is adequately ensured by the insurance contract referred to in Article 19 (1), or, where appropriate, by the insurance of the investigator's or the contracting entity's liability not being part of their employment relationships;

(c) the compensation does not exceed the costs incurred by the subject of the clinical trial or by the entity of the performance study or by the investigator in connection with his participation in the clinical trial or in the performance study, and whether the fee for the investigator is known and fixed in advance, and whether the contracting authority has submitted a written communication, together with the application, of the amount of that remuneration.

(4) In the case of clinical trials or performance studies where it is not possible to obtain its informed consent before the entity is included in the clinical trial or performance study, the Ethics Panel shall assess how the protocol ensures that the informed consent of its legal representative, guardian or representative of the members of the household appointed by the court or body itself under the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices is obtained and shall consider whether it is appropriate to make the inclusion of each individual body subject subject subject subject subject subject's consent conditional. In cases where the integrity of the subject is to be affected by a clinical trial or performance study which is not capable of judgement, in a manner that leaves permanent, irreversible and serious consequences, or in a way associated with a serious risk to his or her life or health, the clinical trial or the performance study may only be conducted with the consent of the judge (5).

§ 16

(1) The Ethics Committee shall deliver an opinion on the clinical trial or performance study on the basis of a written request and after examination of the documentation submitted. The request shall be submitted to the competent Ethics Commission by the contracting authority. The required documents shall be submitted to the Ethics Commission in the Czech language; The Ethics Committee may allow the required documents to be presented in another language, except for informed consent and a summary of the clinical trial plan or performance study.

(2) The applicant, together with a request for an opinion on a clinical trial or a performance study, shall submit the supporting documents necessary for the assessment of a clinical trial or a performance study by the Ethics Committee, in particular documentation enabling the Ethics Committee to assess the facts in accordance with Article 15 (1) and (2). In the course of the assessment, the Ethics Committee shall be entitled to request from the contracting authority further documents and additional information necessary to assess the facts. Where the Ethics Committee requests documents or information in accordance with the second sentence, the time-limit for the opinion of the Ethics Committee referred to in paragraph 3 shall be suspended until the Ethics Committee is notified.

(3) Within 60 days of the date of receipt of the application, the Ethics Committee shall issue a written reasoned opinion to the sponsor on the clinical trial or on the performance study. The opinion of the Ethics Committee shall include:

Citation	Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	07.12.2022
Effective from	22.12.2022
Effective until	-
Status	Valid

Act No. 375 / 2022 Coll.

Law on in vitro medical devices and diagnostic medical devices

Contents

ČÁST PRVNÍ

§ 1

§ 2

ČÁST DRUHÁ

§ 3

§ 4

§ 5

§ 6

§ 7

ČÁST TŘETÍ

§ 8

§ 9

§ 10

ČÁST ČTVRTÁ

§ 11

§ 12

§ 13

§ 14

§ 15

§ 16

Contents

Comments 0

Regulation Information

Public Contracts 5

Partner Websites

Favorites

Browsing History