Decree No. 62 / 2015 Coll.
Decree on the implementation of certain provisions of the Law on in vitro diagnostic medical devices
Valid
Order
Effective from 03.04.2015
Text versions:
26.05.2021
03.04.2015
62
DECLARATION
of 31 March 2015
implementing certain provisions of the Law on in vitro diagnostic medical devices
According to Article 96 (2) of Act No. 268 / 2014 Coll., on Medical Devices and on Amendment to Act No. 634 / 2004 Coll., on Administrative Charges, as amended, ("the Act '), for the implementation of Sections 6 (2), 19 (2) (n), 45 (2), 46 (2), 48 (3), 56 (2) (a), 59 (4), 71 (6) and 74 (5) of the Act:
Subject matter
This decree regulates
(a) the rules of good storage and distribution practice;
(b) the extent of the information given in the prescription;
(c) details of documentation of in vitro diagnostic devices used;
(d) procedures for reporting suspected adverse events, adverse events, safety corrective actions and safety warnings; and
(e) generic groups of in vitro diagnostic devices.
Rules of good storage and distribution practice
(To implement Article 45 (2) of the Act)
(1) The in vitro diagnostic 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 in vitro diagnostic device during storage and transport must not be exposed to temperatures outside the temperature range specified by the manufacturer for the in vitro diagnostic device.
(2) The in vitro diagnostic device must be stored in such a way that:
(a) the storage conditions laid down by the manufacturer are respected;
(b) an in vitro diagnostic device with an expiry date, if specified by the manufacturer, has been placed separately at the designated place and has not been further distributed;
(c) an in vitro diagnostic device with a broken original packaging, thereby degrading the properties or performance of an in vitro diagnostic device, or an in vitro diagnostic device suspected to be contaminated, has been placed separately at the designated site and has not been further distributed;
(d) the in vitro diagnostic device withdrawn from the market and circulated on suspicion of an adverse event or as a result of an adverse event has been placed separately at the designated site and has not been further distributed;
(e) the in vitro diagnostic device in the complaint procedure has been placed separately at the designated location.
(3) The documentation on an in vitro diagnostic device received, delivered or removed contains:
(a) identification of the medical device by indicating the serial number of the production batch preceded by the symbol "LOT" or serial number, if any, by the manufacturer;
(b) the date by which the in vitro diagnostic device can be safely used if specified by the manufacturer;
(c) the quantity or number of in vitro diagnostic devices received, delivered or removed;
(d) identification of customers; and
(e) identification of the manufacturer.
(4) The documentation to be kept and kept by the distributor and importer concerning the process of in vitro withdrawal of a diagnostic device from the market and out of circulation where an adverse event is suspected or due to an adverse event contains:
(a) the definition of personal and material responsibility for the implementation and coordination of withdrawals;
(b) written records of communication between persons responsible for the in vitro withdrawal process;
(c) records of the in vitro withdrawal procedure;
(d) identification of all customers;
(e) records of withdrawal activities; and
(f) evaluation of downloads and measures carried out where withdrawal is not possible.
(5) The documentation referred to in paragraphs 4 and 5 shall be kept for 5 years.
Spaces and technical equipment
(To implement Article 45 (2) of the Act)
(1) In vitro diagnostic devices must be stored in dry and clean storage areas for medical devices which must:
(a) comply with the temperature requirements provided that the manufacturer has established a specific temperature range for the storage of in vitro diagnostic devices, including their control of temperature measurements and records of at least daily maxima and minima; records of these measurements shall be kept for 3 years;
(b) be provided with effective measures against the intrusion of insects or other animals, dust, mold and other in vitro contamination of the diagnostic device;
(c) fulfil the condition that the floors and surfaces of storage areas are resistant to the cleaning and disinfection agents used; and
(d) comply with other specific storage conditions with regard to classification, if any, by the manufacturer.
(2) The areas for the hygiene needs of workers, cleaning facilities, 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 in vitro diagnostic devices.
(3) A procedure shall be established for the storage and distribution of in vitro diagnostic devices to ensure the cleanliness and disinfection of premises and compliance with hygiene requirements. Compliance with these procedures shall be regularly checked and recorded. These records must be kept for 1 year and be in place for inspection.
(4) The distributor, the importer and, where appropriate, the exporter and the seller comply with the procedures governing the regular cleaning, cleaning, disinfection and maintenance of hygiene in the premises intended for distribution and import activities and for the activities of workers in those premises. Compliance with these procedures shall be regularly checked and recorded. Records of checks carried out shall be visibly located in the premises concerned. These records shall be kept for 1 year.
Checks and corrective actions
(To implement Article 45 (2) of the Act)
(1) The distributor and the importer shall establish and document an internal system of control of the processes of good storage and distribution practice, take measures to correct the outcome of internal controls that are carried out at least once a year and keep records of complaints procedures and their results.
(2) The distributor and importer shall, where appropriate and taking into account the nature of the in vitro diagnostic device, draw up and regularly update written procedures for reception activities, controls on supplies, storage, cleaning and maintenance of premises, checks on storage conditions, including protection of in vitro diagnostic devices during storage and transport, ordering, delivery including transport to customers and complaints.
(3) The records referred to in paragraphs 1 and 2 must be kept for 3 years.
Scope of the data on the voucher
(To implement § 46 (5) of the Act)
(1) The following information shall appear on the voucher:
(a) the health insurance code if the in vitro diagnostic device is to be covered by the public health insurance system;
(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 has been 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 prison sentence, and the address of the institution to which the patient was placed for the execution of the security detention; or
6. in the case of a 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 in vitro diagnostic device, the trade name under which the in vitro diagnostic device is placed on the market, the supplement to the name identifying the variant of the in vitro diagnostic device, if any, the assigned code under which the in vitro diagnostic device is registered by the Public Health Insurance Compensation Institute, where applicable, additional specifications and the number of packages in case it is a mass-produced diagnostic device in vitro;
(d) the diagnosis of the patient for whom the in vitro diagnostic device is prescribed; the diagnosis is given using the International Disease Classification Code,
(e) in the case of the prescription of an in vitro diagnostic device which is not covered by public health insurance, the words "Paid patient,"
(f) identification of the health service provider in paper format containing 1),
1. if it is a natural person, name and surname of the health service provider, the address of the place of provision of the health services, the identification number of the place of work of the healthcare establishment, if assigned by the health insurance undertaking, and the 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,
(g) the name and, where appropriate, the names and surnames of the person authorised by the in vitro diagnostic device to be prescribed in writing and, in the case of a 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 by the in vitro diagnostic device to be prescribed, namely the e-mail address and telephone number indicating the international choice, and the indication "Czech Republic" 1);
(h) the signature of the person authorised to prescribe the in vitro diagnostic device; and
(i) the date of issue of the voucher (1).
(2) If the payment of the in vitro diagnostic device is linked to the approval of the medical examiner of the relevant health insurance undertaking,
(a) the medical examiner on the front of the prescription shall give the endorsement "Approved by the medical examiner" or "Not approved by the medical examiner," the date of the decision, the registration number of the decision, the signature and the stamp of the competent medical examiner;
(b) the prescribing doctor on the front of the prescription shall indicate the endorsement "Approved by the medical examiner," the date of the decision of the medical examiner to approve the reimbursement, the registration number of the decision; or
(c) the prescribing physician shall, on the basis of the written consent of the revised medical practitioner to re-prescribe the in vitro diagnostic device, state the endorsement "Approved by the revised medical practitioner," the date of the decision of the revised medical practitioner to approve the repeated remuneration and the registration number of the decision.
(3) The evidence of written consent referred to in paragraph 2 shall be established by persons authorised to prescribe an in vitro diagnostic device no later than 5 working days from the date of its delivery to the patient's medical file.
(4) If it is an in vitro diagnostic device, the payment of which is linked to the approval of the medical examiner of the relevant health insurance company, and the prescribing doctor is the doctor of the Czech Prison Service, the medical examiner sends the certificate to the medical examiner of the relevant health insurance company for confirmation. Otherwise, paragraph 3 shall be followed.
Documentation requirements for in vitro diagnostic devices used
(To implement Article 59 (4) of the Act)
The documentation of in vitro diagnostic devices used for which instruction must be made, in vitro diagnostic devices for which, following the manufacturer's instructions, a safety technical inspection must be carried out and in vitro diagnostic devices designated by the law governing metrology as working meters shall include:
(a) the trade name of the in vitro diagnostic device;
(b) an addition to the name identifying the variant of the in vitro diagnostic device, if any;
(c) identification of the in vitro diagnostic device by the indication of the production batch number preceded by the symbol "LOT" or serial number, if any, by the manufacturer;
(d) the name or name of the manufacturer and distributor;
(e) the date of entry into service of the in vitro diagnostic device; and
(f) a record of the instructions carried out, the security technical checks, repairs and revisions of the in vitro diagnostic device.
Notification of suspected adverse events and notification of adverse events
(To implement § 71 (6) of the Act)
(1) The suspected adverse event referred to in Article 70 (2) of the Act and the adverse event referred to in Article 70 (1) of the Act shall be notified to the Institute by electronic means, signed by a form for reporting the adverse event, in accordance with the European Commission's guidance on the vigilance system. The Institute publishes the form on its website in the Czech and English versions.
(2) Health service providers shall notify the suspected adverse event in accordance with Section 70 (2) of the Institute Act by electronic means by means of a form to report suspected adverse event by the health service provider; the model of this form is set out in the Annex to this order.
(3) In the case of similar adverse events which have occurred in connection with the same in vitro diagnostic device or generic in vitro diagnostic device group and where a underlying cause has been identified or a safety corrective action has been taken, the manufacturer or the authorised representative may notify these adverse events by means of an electronically completed form for periodic summary reporting as indicated by the European Commission on the vigilance system published on his website in the Czech and English versions. The periodic summary report shall be sent by the manufacturer or the authorised representative of the Institute, if they so agree, including the format, content and frequency of the transmission of the periodic report.
(4) The forms referred to in paragraphs 1 to 3 are sent to the Institute in PDF format and XML format at the same time,
(a) via a web interface;
(b) a data message; or
(c) by e-mail.
Scope of information on adverse event investigation
(To implement § 71 (6) of the Act)
(1) The manufacturer collects all information relevant to the investigation of an adverse event.
(2) In determining the extent of the information referred to in paragraph 1, the manufacturer shall always be based on the type of in vitro diagnostic device covered by the adverse event, in particular the way it is used, the results of the analysis carried out, the risk analysis and the severity and effect of the adverse event for users, patients or other natural persons.
(3) The outcome of the adverse event investigation shall be notified by the manufacturer or authorised representative of the Institute by an electronically completed adverse event reporting form; Paragraph 11 (4) applies mutatis mutandis.
Safety corrective measures and safety warnings
(To implement § 74 (5) of the Act)
(1) The manufacturer or authorised representative shall notify the Institute of the security corrective measures established and completed by electronic means of the form for reporting the safety corrective action. The form for safety corrective action and the model of the safety warning as per the European Commission's guidance on the vigilance system is published on its website in the Czech and English versions. Paragraph 11 (4) shall apply mutatis mutandis to the transmission of the Constitution form.
(2) The manufacturer shall ensure that importers, distributors, patients and users of the medical device concerned are immediately informed of the corrective action taken by means of a safety warning.
Generic in vitro diagnostic groups
(To implement § 6 (2) of the Act)
Generic groups of in vitro diagnostic devices shall be established on the basis of a code number and a name according to an internationally recognised in vitro diagnostic device nomenclature (Global Medical Device Nomenclature).
Efficacy
This decree shall take effect on the day of its publication.
Minister:
MUDr.
Annex to Decree No 62 / 2015 Coll.
Model form for reporting suspected adverse events by the health service provider
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. 62 / 2015 Coll., on the implementation of certain provisions of the Law on in vitro diagnostic medical devices |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 03.04.2015 |
|---|---|
| Effective from | 03.04.2015 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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