Decree No. 377 / 2022 Coll.
Decree on the implementation of certain provisions of the Law on in vitro medical devices and diagnostic medical devices
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Order
Effective from 22.12.2022
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22.12.2022
07.12.2022
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377
DECLARATION
of 10 November 2022
on the implementation of certain provisions of the Law on in vitro medical devices and diagnostic medical devices
According to Section 68 of Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices ("the Act '), the Ministry of Health provides for the implementation of Sections 22 paragraphs 3 to 5 and 7, 27 paragraphs 1, 28 paragraphs 3 and 7, 29 paragraphs 6 and 39 paragraphs 6 of the Act:
Subject matter
This decree regulates
(a) particulars of the declaration of the contracting authority's intention to conduct another clinical trial;
(b) particulars of the notification of a serious adverse event during another clinical trial;
(c) details of the notification of the completion of another clinical test and of the report of another clinical test;
(d) particulars of the reporting of significant changes in the documentation of another clinical test;
(e) minimum safety requirements for the device for the purposes of good storage practice;
(f) a list of groups of devices which may endanger human life or health and may only be issued on prescription;
(g) the exact scope and structure of the data on the paper voucher;
(h) the procedure and conditions for communicating prescribers and dispensers with the eRecept system;
(i) the form of the electronic voucher identifier provided by eRecept to prescribers and patients;
(j) the manner and conditions of sending and processing the requirements for the creation, modification and cancellation of an electronic voucher;
(k) the scope of the data needed for the creation, modification and cancellation of the electronic voucher and its particulars;
(l) the procedure and conditions for the communication of identification data pursuant to Article 31 (3) (b) and (4) of the Act; and
(m) the content of the documentation which the health service provider is obliged to keep for the means used.
Forms of reporting the contracting entity's intention to perform another clinical trial
(To implement § 22 (3) of the Act)
Announcement of the intention of the contracting entity to perform another clinical trial pursuant to Section 22 (3) of the Act contains:
(a) identification of the sponsor of another clinical test; in the case of a natural person, the name or, where applicable, the name and surname, telephone number, address of permanent residence or place of residence, and, where there is no permanent residence or place of residence, address of residence or, where appropriate, other address for service, identification number or similar indication, address of registered office or other registered office, where applicable, other address for service, or, in the case of a legal person, name of legal person or business firm, identification number or similar indication, address for service,
(b) the identification of the agent of the sponsor of another clinical trial established in the European Union pursuant to Article 62 (2) of the Regulation on medical devices (1), where the contracting authority is obliged to designate the agent; in the case of a natural person, the name or, where applicable, the name and surname, telephone number, address of permanent residence or place of residence, address of residence, address of residence, address of other address for service, where applicable, and e-mail address, in the case of a natural person involved, the identification number and the address registered in the Commercial Register or other legally modified register as the registered office or, where applicable, another address for service, or, in the case of a legal person, the name of a legal person or a company, identification number or similar indication, the address of the registered office, and, where applicable, another address for service and, where applicable, the e-mail,
(c) identification of the contact person of the contracting entity of another clinical trial or of the contact person of the agent of the contracting entity of another clinical trial established in the European Union pursuant to Article 62 (2) of the Regulation on medical devices (1), to the extent of the name and, where appropriate, the name and surname, telephone number and e-mail address;
(d) details of the manufacturer of the medical device tested and, where appropriate, his authorised representative established in the European Union pursuant to Article 11 of the Regulation on medical devices (1);
(e) the name of another clinical test;
(f) the purpose of another clinical test;
(g) a statement that another clinical trial is not conducted for any of the purposes referred to in Article 62 (1) of the Regulation on medical devices (1);
(h) data enabling the medical device tested to be clearly identified, including the risk class;
(i) identification of the health service provider for which another clinical trial will be conducted, including:
1. if it is a natural person, the name and, where applicable, the names and surnames of the health service provider, the address of the place where the health services are provided; or
2. if it is a legal person, name or business name, address of the registered office;
(j) the designation, address and places of all workplaces where another clinical trial will take place;
(k) the list of countries where the contracting authority intends to carry out another clinical trial;
(l) the name and, where appropriate, the names and surname and telephone number or e-mail address of the principal; and
(m) the planned start and end date of another clinical trial.
Requirements for reporting a serious adverse event during another clinical trial
(To implement § 22 (4) of the Act)
Announcement of a serious adverse event during another clinical trial pursuant to § 22 (4) of the Act contains:
(a) the name of the other clinical test and the protocol number of the other clinical test;
(b) the identification number of another clinical trial allocated to the medical device information system, if assigned;
(c) identification of the sponsor of another clinical test; in the case of a natural person, the name or, where applicable, the name and surname, telephone number, address of permanent residence or place of residence, and, where there is no permanent residence or place of residence, address of residence or, where appropriate, other address for service, identification number or similar indication, address of registered office or other registered office, where applicable, other address for service, or, in the case of a legal person, name of legal person or business firm, identification number or similar indication, address for service,
(d) the name and, where applicable, the names and surname, telephone number and e-mail address of the contact person of the contracting entity for another clinical trial;
(e) the number of subjects of other clinical trials included in another clinical trial at the date of notification of a serious adverse event;
(f) a record of the course of a serious adverse event and its connection with the medical device or test procedure tested;
(g) the date on which the sponsor of another clinical trial received information on suspected serious adverse event;
(h) the date of detection of a serious adverse event;
(i) the date of last use of the test medical device before a serious adverse event occurs;
(j) the entity identification number of another clinical trial where a serious adverse event occurred;
(k) information on the consequences of a serious adverse event;
(l) information on the measures taken; and
(m) the conclusion of the assessment of a serious adverse event.
Details of reporting of completion of another clinical test and reports of another clinical test
(To implement § 22 (5) of the Act)
(1) The notification of the completion of another clinical trial pursuant to § 22 (5) of the Act contains:
(a) the identification number of another clinical trial allocated to the medical devices information system, if assigned;
(b) the name of another clinical test, the data enabling identification of the medical device being tested and the protocol number of another clinical test;
(c) identification of the sponsor of another clinical test; in the case of a natural person, the name or, where applicable, the name and surname, telephone number, address of permanent residence or place of residence, and, where there is no permanent residence or place of residence, address of residence or, where appropriate, other address for service, identification number or similar indication, address of registered office or other registered office, where applicable, other address for service, or, in the case of a legal person, name of legal person or business firm, identification number or similar indication, address for service,
(d) the designation, address and places of all the centres where another clinical trial took place;
(e) the date of completion of another clinical trial, including whether it is premature or orderly, and
(f) the number of subjects of another clinical test included in another clinical test at the date of completion of another clinical test.
(2) The notification of the conclusions of another clinical trial in the form of a report on another clinical trial under Section 22 (5) of the Act contains:
(a) the name of another clinical test, the data enabling identification of the medical device being tested and the protocol number of another clinical test;
(b) the identification number of another clinical trial allocated to the medical device information system, if assigned;
(c) identification of the sponsor of another clinical test; in the case of a natural person, the name or, where applicable, the name and surname, telephone number, address of permanent residence or place of residence, and, where there is no permanent residence or place of residence, address of residence or, where appropriate, other address for service, identification number or similar indication, address of registered office or other registered office, where applicable, other address for service, or, in the case of a legal person, name of legal person or business firm, identification number or similar indication, address for service,
(d) the name and, where applicable, the name and surname of the author of the report on another clinical test, his professional qualifications, his signature and date of issue of the report on another clinical test;
(e) a description of the medical device which has been the subject of another clinical test and, where appropriate, a clearly defined intended purpose for which it has been tested;
(f) a summary of another clinical test containing the purpose of the test, a description of the test, the concept of the test and the methods used, the results of the test and its conclusions;
(g) the date of completion of another clinical trial and, where appropriate, the early termination, temporary interruption or suspension of the test;
(h) a summary of a plan for another clinical trial containing objectives, concepts, ethical aspects, monitoring and quality assurance measures, selection criteria, target patient populations, sample size, treatment schedules, duration of follow-up, concomitant treatment, statistical plan including hypothetical calculation, calculation of sample size and methods of analysis, as well as justification;
(i) the results of another clinical trial containing, in addition to the grounds and considerations, the demography of the subjects, the analysis of the results relating to the selected parameters, the data on the subgroup analysis as well as the compliance with the plan of another clinical trial, the follow-up of missing data and those who have withdrawn from the other clinical trial or are not available for further monitoring;
(j) a summary of the serious adverse events, adverse effects and deficiencies of the medical device and of any relevant corrective action; and
(k) conclusions of the discussion and overall conclusions containing results on safety and efficacy, risk assessment and clinical benefits, discussion of clinical relevance in line with recent clinical care developments, any specific precautions for specific patient groups, consequences for a medical device that is subject to another clinical test, restriction of the test.
Forms of reporting significant changes in documentation of another clinical test
(To implement § 22 (7) of the Act)
Announcement of substantial changes in documentation of another clinical trial according to § 22 (7) of the Act contains
(a) the identification number of another clinical trial allocated to the medical devices information system, if assigned;
(b) the identification of the agent of the sponsor of another clinical trial established in the European Union pursuant to Article 62 (2) of the Regulation on medical devices (1), where the contracting authority is obliged to designate the agent; in the case of a natural person, the name or, where applicable, the names and surname, telephone number, address of permanent residence or place of residence, address of residence, address of residence, address of other address for service, if applicable, and e-mail address, in the case of a natural person involved, the identification number and the address registered in the Commercial Register or other legally modified register as the registered office or, where applicable, another address for service, or, in the case of a legal person, the name of the legal person or company, identification number or similar indication, the address of the registered office and, where applicable, another address for service, and, where applicable, the e-mail,
(c) identification of the contact person of the contracting entity of another clinical trial or of the contact person of the agent of the contracting entity of another clinical trial established in the European Union pursuant to Article 62 (2) of the Regulation on medical devices (1), to the extent of the name and, where appropriate, the name and surname, telephone number and e-mail address;
(d) details of the manufacturer of the medical device tested and, where appropriate, his authorised representative established in the European Union pursuant to Article 11 of the Regulation on medical devices (1);
(e) the name of another clinical test;
(f) the purpose of another clinical test;
(g) data enabling the medical device tested to be clearly identified, including the risk class;
(h) identification of the health service provider for which another clinical trial is conducted, including:
1. if it is a natural person, the name and, where applicable, the names and surnames of the health service provider, the address of the place where the health services are provided; or
2. if it is a legal person, name or business name, identification number, address of the registered office,
(i) the designation, address and places of all the centres where another clinical trial will take place;
(j) the list of countries where the contracting authority intends to carry out another clinical trial;
(k) the name, if any, and surname and telephone number or e-mail address of the principal;
(l) the justification for substantial changes and their indication in the documentation of another clinical test; and
(m) the planned date of major changes in the documentation of another clinical test.
Minimum safety requirements for a device for the purposes of good storage practice
(To implement § 27 (1) of the Act)
(1) The device is treated in such a way that it is not exposed to adverse effects, it is not contaminated, damaged, stolen, degraded or confused, in particular the device must not be subjected to conditions which do not correspond to those laid down by the manufacturer for the device, in particular with regard to temperature range, humidity and exposure to sunlight.
(2) A device which cannot be used under Paragraph 38 (1) of the Act, a device which is not in conformity with the Regulation on medical devices or the Regulation on in vitro diagnostic medical devices, or a device in a complaint procedure because of other doubts about its safety or effectiveness, is stored in a separate and designated place.
(3) The appropriations must be stored in dry and clean rooms intended for storage by means which comply with:
(a) the temperature requirements laid down by the manufacturer of the device, if any, including their temperature and record keeping checks, at least daily maxima and minima of such measurements; records of these measurements shall be kept for 3 years;
(b) the requirement to ensure effective measures against the intrusion of insects or other animals, dust, mold and other contamination of the device;
(c) the condition that the floors and surfaces of storage areas are cleaned and disinfected with an appropriate cleaning and disinfection agent; and
(d) other specific storage conditions, where specified by the manufacturer.
(4) The areas for the hygiene needs of workers, cleaning rooms, rooms for the daily room and the place for the preparation and consumption of food must be separated from the areas for storage and distribution of the means.
(5) A procedure for ensuring the cleanliness and disinfection of premises and compliance with hygiene requirements shall be laid down for the storage and distribution of devices. Compliance with these procedures shall be regularly checked and recorded. The records must be kept for 1 year and be in place for inspection.
Content of documentation of the means used
(To implement § 39 (6) of the Act)
The documentation of the means used for which the briefing must be carried out, the means for which a safety technical inspection must be carried out on the basis of the manufacturer's specification, and the means of law (m2) governing the metrology area shall include:
(a) the trade name of the device,
(b) a name supplement identifying the device model, if any;
(c) unique identification of the device; if the device has not been assigned, the identification of the device by indicating the batch number or serial number of the device, preceded by the words "BATCH NUMBER 'or" SERIUS NUMBER' or, where appropriate, an equivalent symbol,
(d) identification of the risk class of the device;
(e) the name of the manufacturer;
(f) the name or name of the distributor, if the device has not been supplied directly by the manufacturer;
(g) the date of entry into service of the device; and
(h) a record of the instructions carried out, the security technical checks, repairs and revisions of the device.
List of groups of means which may endanger human life or health
(To implement § 28 (3) of the Act)
The groups of devices which may endanger the health or life of a person, even if the intended purpose of their use, is used without the supervision of a physician and which are issued only on medical prescription, are:
(a) intrauterine body;
(b) devices for the treatment of sleep disorders,
(c) implantable devices that are injected,
(d) hearing aids; and
(e) contact lenses for use in children under 15 years of age.
The exact scope and structure of the data on the paper voucher
(To implement § 28 (7) of the Act)
The following information shall appear on the paper voucher:
(a) the code of the health insurance undertaking if the device is to be covered or partly covered by the public health insurance scheme;
(b) identification of the patient containing:
1. name and / or name of patient,
2. patient contact address,
3. patient telephone number, if the patient agrees,
4. the number of the insured person, if assigned; if the insured person's number has not been allocated, the date of birth;
5. the address of the detention prison to which the person was taken if he / she is a person in custody;
6. the address of the detention centre or detention centre to which the person was placed, if it is a person in the execution of a prison sentence or security detention; and
7. in the case of a paper voucher issued at the request of a patient intending to use it in another Member State, the date of birth (3);
(c) the prescribed device, the trade name under which the device is marketed, the adjunct to the name identifying the variant of the device, if any, the code assigned by the Public Health Insurance Compensation Institute, or, where applicable, the data relating to the amount and conditions of the public health insurance reimbursement, including the indication of a refund other than the first, according to the list of all medical devices paid on the basis of the prescription for a voucher issued under the Public Health Insurance Act and the number of packages in the case of a mass-produced device;
(d) an individual design of the characteristics of the device and the code assigned by the Institute for Public Health Insurance Compensation in the case of a contract;
(e) the diagnosis of the patient for whom the device is prescribed; the diagnosis is given using the International Disease Classification Code,
(f) in the case of the prescription of a device which is not covered by public health insurance, the words "Paid patient,"
(g) where the supplement to the device is paid by the employer on the basis of a contractual relationship with the health insurance undertaking, the words "Full payment, supplement paid by the employer,"
(h) identification of the health service provider containing 2), if applicable
1. the natural person, name and surname of the health service provider, the address of the place of supply of the health services, the identification number of the place of work of the healthcare establishment, if any, if assigned by the health insurance undertaking, and the contact telephone number; or
2. a legal person, name or business name, address of the registered office, place of provision of health services, identification number of the place of work of the medical establishment, if assigned by the health insurance company, and contact telephone number,
(i) the name and, where applicable, the name of the person authorised to prescribe the device in writing and, in the case of a paper voucher issued at the request of a patient who intends to use it in another Member State, the professional qualifications and contact details of the person authorised to prescribe the device, namely the e-mail address and the telephone number indicating the international choice, and the indication "Czech Republic" 3),
(j) the signature of the person entitled to prescribe the device; and
(k) the date of issue of the paper voucher.
Procedure and conditions for communication of prescribers and dispensers with eRecept
[To implement Paragraph 29 (6) (a) of the Act]
(1) Communication between the eRecept system and the prescriber or issuer takes place through the data interface of the eRecept system and the information system of the prescriber or issuer, the communication channel being encrypted.
(2) Communication between the eRecept system and the prescriber or issuer also takes place directly via the eRecept web or mobile application according to the Drug Act (4), with the communication channel encrypted.
(3) Data sent to the eRecept system are produced in the form of structured data by the prescriber and the issuer.
(4) Data sent pursuant to paragraph 3 shall be signed by a recognised electronic signature in accordance with the law governing trust services for electronic transactions; This does not apply if prescribers or editors approach eRecept through the National Identification and Authentication Point.
(5) The Institute shall, upon request, issue to the eye optics operator or to the person with whom the health insurance company has concluded a discharge contract under the Public Health Insurance Act, an access certificate for secure communication with the eRecept system; the application for the issue of an access certificate shall be sent by means of an electronic form published on the Institute's website.
Electronic voucher identifier
[To implement § 29 (6) (b) of the Act]
The electronic voucher identifier is generated by eRecept in an alphanumeric form of a character identifier that is transferable to the form of a two-dimensional or one-dimensional barcode.
Scope of the data needed to create the electronic voucher and its details
[To implement § 29 (6) (d) of the Act]
(1) The requirement for creating an electronic voucher contains:
(a) the basic information on the electronic voucher referred to in paragraph 2;
(b) data relating to the patient to whom the device is prescribed to the extent specified in paragraph 3;
(c) data relating to the prescribed device to the extent specified in paragraph 4; and
(d) data relating to the prescriber and provider of health services to the extent specified in paragraph 5.
(2) The requirement for the creation of an electronic voucher shall indicate the electronic voucher:
(a) the period for the use of the electronic voucher;
(b) the way in which an electronic voucher identifier is delivered to the patient; If the method of sending the identifier is chosen via eRecept by text message or by e-mail, the request shall also include the telephone number or e-mail address to which the identifier is to be delivered,
(c) the "ad sum proprium" flag where it is a prescriber's request, which prescribes the means to itself, his husband, his parents, grandparents, children, grandchildren and siblings under the Public Health Insurance Act (5); and
(d) the specification of the requirement to approve the remuneration, including the justification if the reimbursement of the allowance is linked to the approval of the health insurance undertaking concerned.
(3) The requirement to create an electronic voucher should include, in relation to the patient:
(a) the designation of the patient's health insurance undertaking by a code number if the device is to be covered by public health insurance or a sign that the payment of the device results from an international agreement or other legislation for the Ministry of Health;
(b) the name and, where appropriate, the names and surname and address of the patient's residence and, if the place of residence cannot be indicated, the address of the patient's residence;
(c) the patient's telephone number; if it cannot be stated, the address of the patient's whereabouts,
(d) the insured person's number, if allocated; if the insured person's number has not been assigned to the patient or if the insured person's number cannot be determined by his age, the date of birth of the patient,
(e) the address of the detention prison to which the person was taken, if he / she is a person in custody; and
(f) the address of the detention centre or detention centre in which the person was placed, if he is a person in the execution of a prison sentence or a detention centre.
(4) In the requirement to create an electronic voucher, in relation to the prescribed device:
(a) in the case of a mass-produced device:
1. the trade name under which the device is marketed;
2. a name supplement indicating the variant of the device, if any,
3. the code allocated by the Institute for Public Health Insurance Compensation, if any, or data relating to the amount and conditions of the public health insurance reimbursement, including an indication other than the first payment according to the list of all medical devices paid under the prescription for a voucher issued under the Public Health Insurance Act; and
4. Number of packages,
(b) an individual design of the characteristics of the device and the code assigned by the Institute for Public Health Insurance Compensation in the case of a contract;
(c) the diagnosis of the patient for whom the device is prescribed to the patient by means of the International Disease Classification Code; and
(d) method of payment of the device, by stating the words:
1. "payable by the patient," if the device is not to be covered by public health insurance or if the prescriber does not have a contract with the patient's health insurance company, unless it is urgent care,
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Regulation Information
| Citation | Decree No. 377 / 2022 Coll., on the implementation of certain provisions of the Law on in vitro medical devices and diagnostic medical devices |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.12.2022 |
|---|---|
| Effective from | 22.12.2022 |
| Effective until | - |
| Status | Valid |
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