The Implementation Of A Number Of Options. Provisions Of The Law On Medical Devices

Original Language Title: provedení někt. ustanovení zákona o zdravotnických prostředcích

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=83877&nr=62~2F2015~20Sb.&ft=txt

62/2015 Sb.



DECREE



of 31 March 2004. March 2015



on the implementation of certain provisions of the law on medical devices



The Ministry of health shall lay down pursuant to § 96 para. 2 of law No.

268/2014 Coll., on medical devices and on the amendment of Act No.

634/2004 Coll., on administrative fees, as amended,

(hereinafter referred to as the "Act") to implement section 6 (1). 2, § 19 para. 2 (a). n), section 45

paragraph. 2, § 46 para. 2, § 48 para. 3, § 56 para. 2 (a). and, § 59) para.

4, § 71 para. 6 and section 74 para. 5 of the Act:



§ 1



The subject of the edit



This Decree regulates the



and) the details reports of serious adverse events prior to launch

medical device on the market,



(b)) the rules of right import and distribution practices,



(c)) the list of groups of medical devices, which may be life-threatening

or human health,



(d)) the details of the voucher,



(e)) the list of medical devices whose use and disposal

It is well known



(f) particulars of the documentation of medical devices),



(g) the procedures for the notification of a suspect) on adverse event, adverse

events, field safety corrective actions and safety precautions

and



h) generic groups of medical devices.



§ 2



Essentials reporting serious adverse events prior to launch

medical device on the market



[To implement section 19, paragraph 2 (b), n) of the Act]



(1) the reporting of serious adverse events includes the following elements:



and clinical trials) the name of the medical device and the protocol number,



(b) clinical trial identification number) assigned by the European

the Eudamed, medical devices



c) information about the contact person, the name and address of residence, if it is

a natural person, and the name or business name and the address of its registered office,

in the case of a legal person; In addition, both email and phone number,



(d) the name of the medical device under test),



e) number of subjects enrolled in clinical trials to date, reports of serious

adverse events,



f) date of receipt of reports of serious adverse events sponsor

clinical trials,



g) date of incorporation, if known, and a description of the serious adverse events,



(h) the date of application under test) the medical device when the

adverse events,



I) identification number allocated to the person of the subject,



j) information about the aftermath of the adverse event,



k) for information on measures taken,



l) addition of new findings in the course of the evaluation of serious adverse

events and



m) conclusion the evaluation of the serious adverse events.



(2) the reporting of serious adverse events shall be made on the form for the

reporting of serious adverse events as specified by the European Commission

for the reporting of serious adverse events. The Institute shall publish on its

website in Czech and English version of the form for reporting

serious adverse event.



(3) the sponsor of a clinical investigation Institute reported serious adverse events

through electronically completed and advanced electronic

the signature of the signed form for the reporting of serious adverse

events in Czech or English language.



§ 3



The implementation of the activities of the distribution and importation



(For the implementation of section 45 (2) of the Act)



(1) the Distributor and importer of a medical device provide transport

so, in order to meet the transport conditions specified by the manufacturer.

Medical device must not be exposed to adverse impacts to

avoid contamination, damage, theft, damage or

mix-ups. For ensuring the conditions corresponding to the distributor and the importer, even if

If the transport carried out through other people.



(2) if the transport of the medical device ensures a picking list

the seller or provider of health services, must be met

conditions of carriage provided for in paragraph 1.



(3) the Distributor, importer, seller or provider of a picking list

health services stored medical device so that the



and storage conditions have been complied with) specified by the manufacturer,



(b)) medical device with uplynutou expiry date, if the

laid down by the manufacturer, has been placed separately on the marked spot and has not been

distributed,



(c)) the medical device is associated with impaired the original packaging,

the deterioration in the characteristics or performance of a medical

resource, or a medical device, in which the suspect is

contaminated, was located separately on the marked spot and not on

the distributed,



(d)) medical device, downloaded from the market and the circulation is suspected,

adverse event or as a result of the incident, was located

separately on the marked spot and not further distributed,



e) contamination, damage, theft, depreciation and

cross-contamination of medical devices and



f) medical device in the complaint proceedings was placed separately on the

the marked spot.



(4) documentation of an accepted, supplied or vyskladňovaném

medical device contains



and medical device) the identification number of the manufacturing batch,

preceded by the word ' LOT ', or the serial number, if they are

intended by the manufacturer,



(b)) the date by which the medical device is safe to use, if the

provided for by the manufacturer,



(c) the amount or the number of the received), supplied or vyskladňovaného

medical device and



d) identification of the customers.



(5) the dossier, which shall keep the distributor and importer, who

applies to the download process of the medical device from the market and from the circulation

suspected adverse event or as a result of adverse events,

contains



and personal and substantive) definition of responsibilities for the implementation and coordination of the

Download,



(b) the written record of the communication) between those responsible for the process of

Download medical device,



(c)) on the procedure for downloading the records of the medical device,



(d) the identification of all subscribers)



e) records for the download and related activities



(f) the download and evaluation) measures carried out in cases where it is not

Download possible.



(6) the documents referred to in paragraphs 4 and 5 shall be kept for a period of 5 years.



§ 4



Premises and technical equipment



(For the implementation of section 45 (2) of the Act)



(1) a Distributor, importer, and in the case that this corresponds to his needs,

picking list, vendor and provider of health services provide

premises for the business of distribution and importation of medical device

so, in order to prevent damage and contamination.



(2) the importer and the Distributor, if it corresponds to its needs,

picking list, vendor and provider of health services to provide dry

and clean the premises for the storage of medical devices that must

meet



and temperature requirements) is determined by the manufacturer of the specific range

the temperature for the storage of the medical device; and ensures measurement

the temperature and record-keeping at least daily maxim and valleys of these measurements;

the records of these measurements kept for 5 years,



(b)) other specific conditions for storage with regard to risk

the class of the medical device, if they are determined by the manufacturer,



c) effective measures against the entry of insects, animals, dust, mould and other

contamination of the medical device and



(d)) the resistance of floors and surfaces the shelves against disinfectants.



(3) the Distributor and importer to provide rooms for the hygienic needs

employees and for scavenging to be separated from the

the storage space. Facilities for day room and space for the preparation of the

and the consumption of food shall be separated from space for the business of distribution

and imports.



(4) a Distributor, importer, and in the case that this corresponds to his needs,

the picking list and the seller shall comply with the procedures governing the periodic method

cleaning, cleaning, disinfection and maintenance of hygiene in areas designated

for the business of distribution and importation and for the activities of the staff in these

areas. Compliance with these procedures must be periodically inspected

and registered. Inspection records are visibly placed in the

the relevant areas. These records shall be retained for a period of 1 year.



§ 5



Checking and corrective action



(For the implementation of section 45 (2) of the Act)



(1) the Distributor and importer of introducing and documenting an internal control system

distribution and importation processes, take measures to remedy the

the outputs of the internal checks that are performed at least once

a year, and keep records of complaints procedures and their results.



(2) the Distributor and importer and, if necessary, having regard to the nature of the

the medical device to be compiled and regularly updated

written procedures for the receipt, control activities, supplies, storage,

cleaning and maintenance of premises, checking the conditions of storage, including the protection of

medical device during storage and transport, ordering,

delivery to the customer, and complaints, including transport control.



(3) the records referred to in paragraphs 1 and 2 shall be kept for a period of 5 years.



§ 6



List of groups of medical devices, which may endanger the life or

human health



(To implement section 46 (2) of the Act)



A group of medical devices that may endanger the health or


the life of man, even when compliance with the intended purpose of the use,

If used without the supervision of a doctor, and which shall be issued only on the

voucher, are



and the IUD intrauterine),



(b)) medical devices for the treatment of breathing disorders during sleep,



(c) high-performance, inhalers)



d) respiratory medical devices,



e) medical devices for long-term home oxygen therapy helps,



f) contact lenses for children and adolescents under 15 years of age,



g) implantable medical devices that are applied

by injection, and



h) hearing aid.



§ 7



Essentials gift card



(To implement section 48, paragraph 3, of the Act)



(1) on the voucher will contain the following information:



and the health insurance companies) code number,



b) patient name, contact address of the patient, the patient's phone number,

If the patient agrees with it; social security number, if assigned;

If the insured person was not assigned number, date of birth; in the case of

The prison service of the Czech Republic in a patient accused of criminal

the Act shall indicate the name and address of the remand prison, the convicted person for the patient

crime and prison address and name in a patient who is in performance

security detention, address and the name of the institution for the pursuit of security

detention; in the event a gift card issued at the request of a patient, that it

It intends to use in another Member State, outside of such data always lists

^ 1 date of birth),



(c) a prescribed medical device), the trade name under which it is

a medical device is placed on the market, indicating the name of the add-in

a variant of the medical device, if any, under which the code is

medical device registered with the health insurance company, and

number of packages in the case that it is a mass-produced medical

resource,



(d) the characteristics of the individual) of the medical device and the code

under which the medical device is registered with the relevant health

the insurance company, in the event that it is individually made

medical device,



(e) the patient's diagnosis), for which the medical device to the patient

prescribed; diagnosis code using international classification

diseases,



(f)) in the case of the prescription of a medical device, who is not paid

public health insurance, the words "shall be borne by the patient"



g) stamp of the providers of health services that contains ^ 1)



1. in the case of a natural person, the name of the provider of health care services,

on the address of delivery of health services, identification number

the workplace of the medical device, if the health insurance company

granted, and the phone number or



2. in the case of a legal person, the name or business name, registered office, location

provision of health services, the identification number of the workplace

the medical device, if the health insurance company and

telephone number,



h) name of prescribing physician listed in block letters or a name tag

and in the case of a gift card issued at the request of a patient, which it intends to

use in another Member State, with a further professional qualification and

prescriber contact information, email, and phone or fax

with an indication of the international preferences, and the indication "Czech Republic" ^ 1)



I) signature of the prescriber ^ 1) and



j) release date voucher ^ 1).



(2) If a medical device is tied to the approval of the

the review by a doctor the competent health insurance company, then review a doctor



and on the front of the voucher) stating the words "Approved review

doctor ", approval date, signature and stamp of the authorising

medical, or



(b) the written consent of) issues with repeated dispensing of medical

resources; the written consent shall, not later than 14 days from the date of its

exposure of the patient's medical file for inclusion in the. On the front side of the

the voucher is issued on the basis of the written consent of medical

the prescriber shall note "approved the review by a doctor".



(3) in the case of a medical device, whose remuneration is tied to the

approval of a revision doctor competent sickness insurance fund, and

Prescriber is a doctor of the prison service of the Czech Republic, sent to

a voucher for a medical device review doctors competent medical

the insurance company to confirm this doctor. Otherwise, shall follow the procedure referred to in paragraph 2

(a). (b)).



(4) in the case of a prescription medical device that can directly

or indirectly endanger human health, and which is not paid from the system

public health insurance, the voucher shall indicate the elements referred to in

with the exception of paragraph 1 (a)).



§ 8



Requirements on medical device of the voucher issued in another

Member State of the European Union



(To implement section 48, paragraph 3, of the Act)



Essentials gift card for medical devices set out in this

the Decree shall not be required, if it is a voucher issued in another Member

State of the European Union and the voucher contains the elements according to the requirements

This member State ^ 2).



§ 9



The list of medical devices whose use and disposal is

generally known



[To implement section 56 (2) of the Act)]



Medical devices whose use and disposal is

widely known, are



and lubricant gels) and



b) condoms.



§ 10



Requirements documentation used medical devices



(For the implementation of section 59 (4) of the Act)



Documentation used for medical devices, which must be

today at the briefing, or must be on the basis of the instruction of the manufacturer

maintenance is performed, or that other legislation

marked as working of the meter, contains the following information:



and the trade name of the medical device),



(b) the name of the add-in) that indicates a variation of the medical device, if the

There are,



(c)) identification of medical device manufacturing batch numbers,

that is the word ' LOT ', or the serial number, if they are

intended by the manufacturer,



d) catalogue number assigned to a medical device variants

by the manufacturer, if this number exists,



(e) indication of the risk class) or the fact that it is the active

implantable medical device or diagnostic medical

in vitro, resource



(f) the name or business name of the manufacturer) and the Distributor,



g) location of the medical device in a healthcare facility

providers of health services, in the case of a fixed installed

medical device,



h) the date of entry into service and



I) information about your instruktážích, made by professional maintenance,

any repairs made and made revisions.



§ 11



Reporting suspected adverse event and notification of adverse

events



(To implement section 71 (6) of the Act)



(1) incident is suspected according to the § 70 para. 2 of the Act, and

adverse events pursuant to section 70 para. 1 of the Act shall be notified to the Institute

electronically completed and signed by an advanced electronic signature

form for reporting adverse events according to the guideline of the European Commission to

the vigilance system. The Institute publishes on its Web form

pages in Czech and English versions.



(2) providers of health services shall notify the suspected adverse

incident in accordance with § 70 para. 2 of the Act the Institute electronically completed and

an advanced electronic signature signed a form for reporting

suspected adverse event to the provider of health care services; pattern

This form is shown in the annex to this Decree.



(3) in the case of similar incidents which have occurred in the context of

with the same medical device or type of resource, and for which the

the underlying cause has been identified, or was carried out safety

corrective action, may notify the manufacturer or the authorised representative of the

adverse events electronically completed and advanced electronic

the signature of the signed form for the periodic summary reports referred to in

guideline of the European Commission to the vigilance that the Institute exposes the

their website in Czech and English versions. Periodic

Summary report be sent to the manufacturer or the authorised representative of the Institute,

If this is agreed between, and including, the format, content and frequency of the

the sending of periodic reports.



(4) the form referred to in paragraphs 1 to 3 shall be sent to the Institute in PDF format and

at the same time as XML, and it



a) via a Web interface,



(b) the data message), or



(c)) by electronic mail.



§ 12



Range of information about the investigation of the incident



(To implement section 71 (6) of the Act)



(1) the manufacturer collects all information relevant for the investigation

adverse events.



(2) the manufacturer in determining the extent of the information referred to in paragraph 1 is based on

always from the nature of the medical device covered by the side

events, in particular of its manner of use, of the findings made by the

analysis, risk analysis, and of the gravity and consequence of adverse events

for the user, the patient or another individual.



(3) the outcome of the investigation of the incident indicates the manufacturer or

authorised representative the Institute electronically completed and guaranteed by the

electronic signature signed a form for the reporting of adverse

events; the provisions of § 11 (1) 4 apply here mutatis mutandis.



section 13 of the




Safety corrective actions and safety alerts



(To implement section 74, paragraph 5, of the Act)



(1) the manufacturer or the authorised representative of the Institute set out and Announces

completed electronically safety corrective actions completed and

an advanced electronic signature signed a form for reporting

safety corrective action. The form for security remediation

the measures and the model of the safety warning in accordance with instruction of the European Commission

to the vigilance system the Institute publishes on its website in

Czech and English versions. For the sending of a form of Institute of § 11 (1)

4 apply mutatis mutandis.



(2) the manufacturer shall ensure that importers, distributors, and

users of the relevant medical device shall immediately be informed

the corrective action taken by the security

the warning.



§ 14



Generic groups of medical devices



(For the implementation of article 6, paragraph 2, of the Act)



Generic groups of medical devices shall be determined on the basis of the

the code number and the name according to an internationally recognised nomenclature

medical devices (Global Medical Device Nomenclature).



§ 15



The effectiveness of the



This Decree shall take effect on the date of its publication.



Minister:



Mudr. Němeček, MBA, in r.



Annex



Model of form for the reporting of suspected adverse event

provider of health services



1) the annex to the implementing Commission directive 2012/52/EU of 20. December

2012, laying down provisions to facilitate the recognition of

regulations issued in another Member State.



2) Article. 11 of the directive of the European Parliament and of the Council of 2011/24/EU of 9 June.

March 2011 on the application of patients ' rights in cross-border care.