Decree No. 186 / 2021 Coll.
Decree on the implementation of certain provisions of the Law on Medical Devices
Valid
Order
Effective from 26.05.2021
186
DECLARATION
of 27 April 2021
implementing certain provisions of the Law on Medical Devices
According to Section 68 of Act No. 89 / 2021 Coll., on Medical Devices, hereinafter referred to as "the Act ', the Ministry of Health provides for the implementation of Sections 13 (3) and (4), 27 (1), 28 (2) and (6) and 39 (6) of the Act:
Subject matter
This decree regulates
(a) the particulars of the notification of the contracting entity's intention to conduct another clinical trial;
(b) particulars of notification of a serious adverse event during another clinical trial;
(c) minimum safety requirements for a device for the purposes of good storage practice;
(d) a list of groups of devices which may endanger human life or health and may only be issued on prescription;
(e) the extent of the particulars given in the prescription; and
(f) the content of the documentation which the health service provider is obliged to keep for the means used.
Forms of notification of the contracting entity's intention to conduct another clinical trial
(To implement Article 13 (3) of the Act)
The notification of the contracting authority's intention to conduct another clinical trial under Paragraph 13 (3) of the Act shall include:
(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, where applicable, other address for service, in the case of a natural person involved, the identification number and the address registered in the business register or other legally modified register as the place of business, or, where applicable, another address for service, or, in the case of a legal person, the name of the legal person or business firm, the identification number or similar indication, the address of the registered office or, where applicable, another address for service,
(b) the name and, where appropriate, the names and surname, telephone number and e-mail address of the contact person of the contracting entity for another clinical trial;
(c) the name of another clinical test;
(d) the purpose of another clinical test;
(e) a statement that another clinical trial is not carried out for any of the purposes referred to in Article 62 (1) of the Regulation on medical devices;
(f) data enabling the means of testing to be clearly identified;
(g) identification of the health service provider containing:
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;
(h) the designation and address of the workplace where another clinical trial will take place;
(i) the name and, where applicable, the names and surname and telephone number or e-mail address of the principal; and
(j) the planned date of start and end of another clinical trial.
Forms of notification of a serious adverse event during another clinical trial
(To implement Article 13 (4) of the Act)
Notification of a serious adverse event shall include:
(a) the name of the other clinical test of the device 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) 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;
(d) the number of subjects assigned to another clinical trial at the date of notification of a serious adverse event;
(e) description and evaluation of a serious adverse event;
(f) the date on which the sponsor of another clinical trial received a report of suspected serious adverse event;
(g) the date of detection of a serious adverse event;
(h) the date of last use of the tested device before an adverse event occurs;
(i) the entity's identification number;
(j) information on the consequences of an adverse event;
(k) information on the measures taken; and
(l) the conclusion of the assessment of a serious adverse event.
Minimum safety requirements for a device for the purposes of good storage practice
(To implement § 27 (1) of the Act)
(1) The device must be handled 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 exposed to temperatures outside the temperature range specified by the manufacturer for the device.
(2) A means which cannot be used pursuant to Paragraph 38 (1) of the Act or a means of complaint proceedings because of other doubts as to its safety or effectiveness must be placed separately in the designated place during its storage.
(3) The funds must be stored in dry and clean areas intended for storage by the means which must:
(a) comply with the temperature requirements where the manufacturer has established a specific temperature range for the storage of the device, including a check of the temperature and record keeping of at least daily maxima and minima of such measurements; records of these measurements shall be kept for 3 years;
(b) be ensured by effective measures against the intrusion of insects or other animals, dust, mold and other contamination of the product;
(c) satisfy the condition that the floors and surfaces of storage areas are cleaned and disinfected with an appropriate cleaning and disinfection agent; and
(d) comply with other specific storage conditions, where provided 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.
List of groups of means which may endanger human life or health
(To implement § 28 (2) 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; and
(d) hearing aids.
Scope of data on the paper voucher
(To implement § 28 (6) 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 by a 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. in the case of a patient who is located in the institution of the Prison Service of the Czech Republic, accused of a criminal offence, the address of the detention prison to which the patient was taken, if any, in the case of a patient convicted of a criminal offence, the address of the prison to which he was placed for the execution of the sentence of imprisonment, and the address of the institution where the patient was placed for the execution of the security detention,
6. in the case of a paper voucher issued at the request of a patient who intends to use it in another Member State, the date of birth (1),
(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) identification of the health service provider containing 1);
1. if it is a natural person, name and surname of the health service provider, address of the place of provision of the health services, identification number of the place of work of the healthcare establishment, if assigned by the health insurance undertaking, and contact telephone number; or
2. if it is 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 healthcare establishment, if assigned by the health insurance company, and contact telephone number,
(h) the name and, where applicable, the names of the person entitled 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 entitled to prescribe the device, namely the e-mail address and the telephone number indicating the international choice, and the indication "Czech Republic" 1),
(i) the signature of the person entitled to prescribe the device; and
(j) the date of issue of the paper voucher.
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 the manufacturer's instructions require a safety technical inspection and the means which are designated by the legislation governing metrology as working meters 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 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 or the fact that it is an active implantable device;
(e) the name of the manufacturer;
(f) the name or name of the distributor, if the product 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.
Efficacy
This Decision shall enter into force on 26 May 2021.
Minister for Health:
Prof. MUDr. Arenberger, DrSc., MBA, v. r.
1) The Annex to Commission Implementing Directive 2012 / 52 / EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescription issued in another Member State.
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Regulation Information
| Citation | Decree No. 186 / 2021 Coll., on the implementation of certain provisions of the Law on Medical Devices |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.05.2021 |
|---|---|
| Effective from | 26.05.2021 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
Public Contracts 5
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