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CONDUCTION OF A REMOTE AUDIT IN UKRAINE.
HOW IS IT ORGANIZED?
Vladyslav Kasianenko
Auditor at Improve Medical CAB
Which type of conformity assessment you are?
REMOTE AUDIT RECOGNITION
ON-SITE AUDIT UNANNOUNCED AUDIT
The market of medical devices in Ukraine in
2022
• Ukrainian media Apteka.ua calculates the total number of sales in
Ukrainian Hryvnia from year to year.
• Based on their research, it was calculated that in comparison with
2021, the number of income in 2022 fell for -6,1 % for medicines,
- 9.5 for dietary supplements and – 17.7% for medical devices
• Main reason for this fall is russian-Ukrainian war in Ukraine:
destroyed infrastructure, warehouses etc.
Legislation of Ukraine that
applied to medical devices
ISO/IEC 17021
ISO/IEC 17065
Technical Regulation
on Medical Devices
for IVD (Regulation
754)
Law of Ukraine "On
Standardization"
Technical regulations
for active implantable
medical devices
(Decree 755)
Technical regulations
for medical devices
(Decree 753)
Law of Ukraine "On
General Safety of
Non-Food Products"
Law of Ukraine "On
State Market
Supervision and Control
of Non-Food Products"
Law of Ukraine "On
Accreditation of
Conformity
Assessment Bodies"
Law of Ukraine "On
Technical Regulations
and Conformity
Assessment"
Usual ways of
conformity assessment of
Ukraine for medical
devices
Onsite
regular audit
Recognition of NB
conformity
assessment
results
Remote audits
(implemented
once the COVID
began)
Onsite regular audit
Standard way of conformity assessment:
• Requires the onsite presence of auditors
• Involves more documentation from both sites
• Equivalent to MDD
The manufacturers of medical devices passed
the conformity assessment onsite and placed on
the market /put into service in Ukraine receive
the certificate for their MD for 5 years with further
yearly surveillance.
1.
List of documents attached to the application for conducting conformity
assessment procedure (on-site audit)
List of documents attached to the application for conducting conformity
assessment procedure (on-site audit)
Recognition Procedure
Faster way of conformity assessment:
• Do not require the onsite presence of auditors
• Less documentation and lower cost
• Performed on a basis of an Agreement with
European Notified Body
The manufacturers of medical devices passed
the conformity assessment by recognition
procedure and placed on the market /put into
service in Ukraine receive the certificate for their
MD on the basis of CE certificate issued by NB
with further yearly surveillance.
2.
Agreement on recognition of conformity
assessment results
The process of signing the Agreement
with a EU notified body is a very
significant process that requires lengthy
negotiations, confirmation of the
competence of the Ukrainian side and
accreditation certificate.
2.
Developed taking into account the comments of European notified bodies, and in
accordance with ISO / IEC Guide 68 "Agreements on the recognition and
acceptance of conformity assessment results".
Law of Ukraine "On Technical Regulations and Conformity Assessment"
Section VIII RECOGNITION OF CONFORMITY ASSESSMENT RESULTS
Article 45. Recognition of the results of conformity assessment conducted outside Ukraine
1. The results of conformity assessment of technical regulations conducted in another country shall be accepted and
recognized in Ukraine if the conformity assessment procedures applied in that country (even if they differ from Ukrainian
procedures) provide the same level of conformity to the relevant technical regulations as Ukrainian conformity assessment
procedures.
2. Documents on compliance with the requirements of technical regulations issued as a result of conformity assessment
conducted in another state are accepted if Ukraine and another state have concluded an international agreement of Ukraine on
mutual recognition of the results of conformity assessment
3. Designated bodies have the right to recognize the results of conformity assessment of technical regulations
conducted by foreign accredited conformity assessment bodies on the basis of agreements with such conformity
assessment bodies, if:
• national accreditation bodies that accredit conformity assessment bodies both in Ukraine and in another country are
members of an international or regional accreditation organization and / or have concluded a mutual recognition
agreement with such organization regarding the relevant conformity assessment activities;
• the designated body, on the basis of a conformity assessment document issued by a foreign conformity assessment
body, applies the conformity assessment procedure or part thereof and issues the conformity assessment
document provided for in this procedure under its responsibility.
Law of Ukraine "On Technical Regulations and Conformity Assessment"
The results of conformity assessment of technical regulations conducted in another state shall be accepted
and recognized in Ukraine if the conformity assessment procedures applied in that state (even if they differ
from Ukrainian procedures) provide the same level of conformity to the relevant technical regulations as
Ukrainian conformity assessment procedures.
Technical regulations for medical
devices (CMU Resolution 753)
Technical regulations for medical
devices for in-vitro diagnostics (CMU
Resolution 754)
Technical regulations for active
implantable medical devices (CMU
Resolution 755)
Drafted on the basis of the EU Council Directive of 14 June 1993 №
93/42 / EEC on medical devices
Drafted on the basis of Directive 98/79 / EEC of the European
Parliament and of the Council of 27 October 1998 on in vitro
diagnostic medical devices.
Developed on the basis of the EU Council Directive of 20 June 1990
№ 90/385 / EEC on the approximation of the laws of the Member
States relating to active implantable medical devices.
List of documents attached to the application for conducting conformity
assessment procedure (recognition procedure)
Remote audits
• Both operator and auditors are present online
• Involves a lot of additional documentation from both sites: Checklists, risk
analysis and approval from both sites
3.
During remote audits it is necessary
to provide the stable Internet
connection from both sides, more
time for analyzation before the audit
and an opportunity for auditors to
verity all manufacturing processes
(streaming and guiding of person
who holds the camera)
Remote audits basis
• IAF Informative Document For Management of Extraordinary
Events or Circumstances Affecting ABs, CABs and Certified
Organizations - IAF ID 3: 2011
• IAF MANDATORY DOCUMENT FOR THE USE OF INFORMATION
AND COMMUNICATION TECHNOLOGY (ICT) FOR
AUDITING/ASSESSMENT PURPOSES IAF MD 4:2022
• MDCG 2020-4 Guidance on temporary extraordinary measures
related to medical device Notified Body audits during COVID-19
quarantine orders and travel restrictions - This guidance takes
immediate effect and is valid for the whole period of duration of
the pandemic COVID-19 as declared by the World Health
Organisation.
End of COVID-19 pandemic in 2023
End of COVID-19 pandemic in 2023
End of remote audit era
Increasing of time to conduct the audit
More travel expenses (flights, train, hotel etc)
Time increasing for conformity
assessment
War in Ukraine circumstances
• On February 24, 2022, russia has started a full-scale war in
Ukraine. Conformity assessment bodies shifted to remote
audits to avoid interruption of medical devices supply on
Ukrainian market.
• Despite the Covid-19 measures, war is an internal
circumstance
• The surveillance audits still should be conducted once in 12
month
• The conformity assessment body Improve Medical has
established internal procedure for risk analysis for remote
audits in order to avoid any non-safe device getting into
market
IAF position on
postponement
From IAF FAQ Q10:
In consideration of this extraordinary
period, for schemes of management system
certification, product certification, and
certification of persons under IAF MLA, if
it is not possible to perform evaluation
activities (physically or as per IAF MD4:
2018), such as audits or exams, and if the
conditions recommended by IAF ID3:
2011 are satisfied, all the conformity
assessment activities (e.g. surveillance,
recertification) may be postponed for up to
6 months, and the validity of any output
of any conformity assessment activity (e.g.
a certificate or report) may be extended
for a corresponding period of up to 6
months.
So:
If it is not possible to
conduct the audit from
CAB side – it is possible to
postpone, but if it is the
request from operator, it
should confirm such
circumstances.
CAB position
Documents sent to operator for a remote audit
Usual:
• Plan for the audit
Specific:
• Check-list for remote
audit conduction
• Ckeck-list of remote
audit capabilities
Checklist for remote audit conduction
Requirements of EN ISO 13485
or Technical Regulation of
Ukraine
It is needed to indicate
the exact name of the
doc and explanation
what is it if not possible
to identify from the name
Example
SOP_12_v8_Medical
device file
SOP_4.2_v9_Document
ation Management
TF_01_v2_Product
description
RMF_v2_Risk
Management file
TF_02_v4_List of
applicable standards
With Register of all documents of QMS with versions it is much easier for
conformity assessment body to prepare for the audit.
Example 2
SOP_15_v1_Infrustruct
ure Management
F_15/1_v7_List of
equipment for
maintenance
WI_15/2_v0_Hygiene
WI_15/3_v7_Clean
room area Management
SOP_16_v3_Work
environment
etc
Common mistakes
• Relevant fields are not filled fully
• Documents weren’t sent
• Documents weren’t prepared and the operator begins to
prepare them within the audit
• Documents were sent too late, so the audit team did not
have an opportunity to look through
Checklist of remote audit capabilities
The checklist of remote audit capabilities is one
of the basic documents for remote audit risk
assessment
Documents for Ukrainian market
• Declaration of conformity
• IFU
• Labeling (primary, secondary,
group)
• Checklist of Essential
requirement according to Annex
1 of Ukrainian Technical
(ERC/GSPR equivalent)
As part of the conformity assessment procedure, the manufacturer should confirm
the compliance of medical devices with the requirements of Annex 1 of the
Technical Regulations. This requirement is duplicated with a similar annex set out in
the relevant EU Directives and is called the Essential Requirements (Checklist).
Such requirements are made out in the table which is well known to the
manufacturer.
Although the Technical Regulations are based on the EU Directives, the structure of
the Essential Requirements is somewhat different from the structure of the Essential
Requirements of the EU Directives.
Check-list (Essential requirement according to Annex 1
of Ukrainian Technical / (Essential Requirements) /
General Safety and Performance Requirements
Example of filled in checklist
.
Language of instruction and labeling
Labeling of goods, instructions for their use, etc. are performed
in the state language and in the regional or minority language.
According to the decision of the producers of goods, its
translation into other languages ​​may be placed next to the text
presented in the state language. Labeling of goods for export is
performed in any language.
The information on the packaging of the medical device will be received by the
consumer, who in accordance with the Law "On Consumer Protection" has the right to
receive the necessary, reliable and timely information.
LAW OF UKRAINE
On ensuring the functioning of the Ukrainian language as the state language
(Information of the Verkhovna Rada (VRU), 2019, № 21, p.81)
UA.TR.000
The identification number of the conformity assessment body shall be
indicated next to the conformity mark, if the involvement of the body
is provided by the relevant procedure.
Medical devices:
The mark of conformity shall be applied at the decision of the manufacturer on medical devices or on
its packaging, as well as to the instructions for use, if such a document is used.
Medical devices for in-vitro diagnostics: The mark of conformity shall apply to the
instructions for use, if such instructions are required, and to the outer packaging, and if
possible to the medical device itself.
Declaration of conformity
The Technical Regulation for medical devices of Ukraine do not specify the requirements for the
content, approximate structure or form of the declaration of conformity. Thus, the form of the
Declaration is free.
Basic information to be provided in the Declaration:
Name of medical device (s);
Manufacturer's name;
Name of production sites;
Name of authorized representative;
Product classification (all possible modifications);
Conformity assessment procedure, number of the
Technical Regulation;
Information that the medical device meets the basic
requirements of the relevant TR;
Date and information about the person signing the
declaration;
Validity of the declaration of conformity;
Link to version and technical file number (if applicable)
Conduction of a remote audit in Ukraine. How is it organized?

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Conduction of a remote audit in Ukraine. How is it organized?

  • 1. CONDUCTION OF A REMOTE AUDIT IN UKRAINE. HOW IS IT ORGANIZED? Vladyslav Kasianenko Auditor at Improve Medical CAB
  • 2. Which type of conformity assessment you are? REMOTE AUDIT RECOGNITION ON-SITE AUDIT UNANNOUNCED AUDIT
  • 3. The market of medical devices in Ukraine in 2022 • Ukrainian media Apteka.ua calculates the total number of sales in Ukrainian Hryvnia from year to year. • Based on their research, it was calculated that in comparison with 2021, the number of income in 2022 fell for -6,1 % for medicines, - 9.5 for dietary supplements and – 17.7% for medical devices • Main reason for this fall is russian-Ukrainian war in Ukraine: destroyed infrastructure, warehouses etc.
  • 4. Legislation of Ukraine that applied to medical devices ISO/IEC 17021 ISO/IEC 17065 Technical Regulation on Medical Devices for IVD (Regulation 754) Law of Ukraine "On Standardization" Technical regulations for active implantable medical devices (Decree 755) Technical regulations for medical devices (Decree 753) Law of Ukraine "On General Safety of Non-Food Products" Law of Ukraine "On State Market Supervision and Control of Non-Food Products" Law of Ukraine "On Accreditation of Conformity Assessment Bodies" Law of Ukraine "On Technical Regulations and Conformity Assessment"
  • 5. Usual ways of conformity assessment of Ukraine for medical devices Onsite regular audit Recognition of NB conformity assessment results Remote audits (implemented once the COVID began)
  • 6. Onsite regular audit Standard way of conformity assessment: • Requires the onsite presence of auditors • Involves more documentation from both sites • Equivalent to MDD The manufacturers of medical devices passed the conformity assessment onsite and placed on the market /put into service in Ukraine receive the certificate for their MD for 5 years with further yearly surveillance. 1.
  • 7. List of documents attached to the application for conducting conformity assessment procedure (on-site audit)
  • 8. List of documents attached to the application for conducting conformity assessment procedure (on-site audit)
  • 9. Recognition Procedure Faster way of conformity assessment: • Do not require the onsite presence of auditors • Less documentation and lower cost • Performed on a basis of an Agreement with European Notified Body The manufacturers of medical devices passed the conformity assessment by recognition procedure and placed on the market /put into service in Ukraine receive the certificate for their MD on the basis of CE certificate issued by NB with further yearly surveillance. 2.
  • 10. Agreement on recognition of conformity assessment results The process of signing the Agreement with a EU notified body is a very significant process that requires lengthy negotiations, confirmation of the competence of the Ukrainian side and accreditation certificate. 2. Developed taking into account the comments of European notified bodies, and in accordance with ISO / IEC Guide 68 "Agreements on the recognition and acceptance of conformity assessment results".
  • 11. Law of Ukraine "On Technical Regulations and Conformity Assessment" Section VIII RECOGNITION OF CONFORMITY ASSESSMENT RESULTS Article 45. Recognition of the results of conformity assessment conducted outside Ukraine 1. The results of conformity assessment of technical regulations conducted in another country shall be accepted and recognized in Ukraine if the conformity assessment procedures applied in that country (even if they differ from Ukrainian procedures) provide the same level of conformity to the relevant technical regulations as Ukrainian conformity assessment procedures. 2. Documents on compliance with the requirements of technical regulations issued as a result of conformity assessment conducted in another state are accepted if Ukraine and another state have concluded an international agreement of Ukraine on mutual recognition of the results of conformity assessment 3. Designated bodies have the right to recognize the results of conformity assessment of technical regulations conducted by foreign accredited conformity assessment bodies on the basis of agreements with such conformity assessment bodies, if: • national accreditation bodies that accredit conformity assessment bodies both in Ukraine and in another country are members of an international or regional accreditation organization and / or have concluded a mutual recognition agreement with such organization regarding the relevant conformity assessment activities; • the designated body, on the basis of a conformity assessment document issued by a foreign conformity assessment body, applies the conformity assessment procedure or part thereof and issues the conformity assessment document provided for in this procedure under its responsibility.
  • 12. Law of Ukraine "On Technical Regulations and Conformity Assessment" The results of conformity assessment of technical regulations conducted in another state shall be accepted and recognized in Ukraine if the conformity assessment procedures applied in that state (even if they differ from Ukrainian procedures) provide the same level of conformity to the relevant technical regulations as Ukrainian conformity assessment procedures. Technical regulations for medical devices (CMU Resolution 753) Technical regulations for medical devices for in-vitro diagnostics (CMU Resolution 754) Technical regulations for active implantable medical devices (CMU Resolution 755) Drafted on the basis of the EU Council Directive of 14 June 1993 № 93/42 / EEC on medical devices Drafted on the basis of Directive 98/79 / EEC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Developed on the basis of the EU Council Directive of 20 June 1990 № 90/385 / EEC on the approximation of the laws of the Member States relating to active implantable medical devices.
  • 13. List of documents attached to the application for conducting conformity assessment procedure (recognition procedure)
  • 14. Remote audits • Both operator and auditors are present online • Involves a lot of additional documentation from both sites: Checklists, risk analysis and approval from both sites 3. During remote audits it is necessary to provide the stable Internet connection from both sides, more time for analyzation before the audit and an opportunity for auditors to verity all manufacturing processes (streaming and guiding of person who holds the camera)
  • 15. Remote audits basis • IAF Informative Document For Management of Extraordinary Events or Circumstances Affecting ABs, CABs and Certified Organizations - IAF ID 3: 2011 • IAF MANDATORY DOCUMENT FOR THE USE OF INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) FOR AUDITING/ASSESSMENT PURPOSES IAF MD 4:2022 • MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions - This guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation.
  • 16. End of COVID-19 pandemic in 2023
  • 17. End of COVID-19 pandemic in 2023 End of remote audit era Increasing of time to conduct the audit More travel expenses (flights, train, hotel etc) Time increasing for conformity assessment
  • 18. War in Ukraine circumstances • On February 24, 2022, russia has started a full-scale war in Ukraine. Conformity assessment bodies shifted to remote audits to avoid interruption of medical devices supply on Ukrainian market. • Despite the Covid-19 measures, war is an internal circumstance • The surveillance audits still should be conducted once in 12 month • The conformity assessment body Improve Medical has established internal procedure for risk analysis for remote audits in order to avoid any non-safe device getting into market
  • 19. IAF position on postponement From IAF FAQ Q10: In consideration of this extraordinary period, for schemes of management system certification, product certification, and certification of persons under IAF MLA, if it is not possible to perform evaluation activities (physically or as per IAF MD4: 2018), such as audits or exams, and if the conditions recommended by IAF ID3: 2011 are satisfied, all the conformity assessment activities (e.g. surveillance, recertification) may be postponed for up to 6 months, and the validity of any output of any conformity assessment activity (e.g. a certificate or report) may be extended for a corresponding period of up to 6 months. So: If it is not possible to conduct the audit from CAB side – it is possible to postpone, but if it is the request from operator, it should confirm such circumstances. CAB position
  • 20. Documents sent to operator for a remote audit Usual: • Plan for the audit Specific: • Check-list for remote audit conduction • Ckeck-list of remote audit capabilities
  • 21. Checklist for remote audit conduction Requirements of EN ISO 13485 or Technical Regulation of Ukraine It is needed to indicate the exact name of the doc and explanation what is it if not possible to identify from the name
  • 23. With Register of all documents of QMS with versions it is much easier for conformity assessment body to prepare for the audit. Example 2 SOP_15_v1_Infrustruct ure Management F_15/1_v7_List of equipment for maintenance WI_15/2_v0_Hygiene WI_15/3_v7_Clean room area Management SOP_16_v3_Work environment etc
  • 24. Common mistakes • Relevant fields are not filled fully • Documents weren’t sent • Documents weren’t prepared and the operator begins to prepare them within the audit • Documents were sent too late, so the audit team did not have an opportunity to look through
  • 25. Checklist of remote audit capabilities
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  • 28. The checklist of remote audit capabilities is one of the basic documents for remote audit risk assessment
  • 29. Documents for Ukrainian market • Declaration of conformity • IFU • Labeling (primary, secondary, group) • Checklist of Essential requirement according to Annex 1 of Ukrainian Technical (ERC/GSPR equivalent)
  • 30. As part of the conformity assessment procedure, the manufacturer should confirm the compliance of medical devices with the requirements of Annex 1 of the Technical Regulations. This requirement is duplicated with a similar annex set out in the relevant EU Directives and is called the Essential Requirements (Checklist). Such requirements are made out in the table which is well known to the manufacturer. Although the Technical Regulations are based on the EU Directives, the structure of the Essential Requirements is somewhat different from the structure of the Essential Requirements of the EU Directives. Check-list (Essential requirement according to Annex 1 of Ukrainian Technical / (Essential Requirements) / General Safety and Performance Requirements
  • 31. Example of filled in checklist
  • 32. . Language of instruction and labeling Labeling of goods, instructions for their use, etc. are performed in the state language and in the regional or minority language. According to the decision of the producers of goods, its translation into other languages ​​may be placed next to the text presented in the state language. Labeling of goods for export is performed in any language. The information on the packaging of the medical device will be received by the consumer, who in accordance with the Law "On Consumer Protection" has the right to receive the necessary, reliable and timely information. LAW OF UKRAINE On ensuring the functioning of the Ukrainian language as the state language (Information of the Verkhovna Rada (VRU), 2019, № 21, p.81)
  • 33. UA.TR.000 The identification number of the conformity assessment body shall be indicated next to the conformity mark, if the involvement of the body is provided by the relevant procedure. Medical devices: The mark of conformity shall be applied at the decision of the manufacturer on medical devices or on its packaging, as well as to the instructions for use, if such a document is used. Medical devices for in-vitro diagnostics: The mark of conformity shall apply to the instructions for use, if such instructions are required, and to the outer packaging, and if possible to the medical device itself.
  • 34. Declaration of conformity The Technical Regulation for medical devices of Ukraine do not specify the requirements for the content, approximate structure or form of the declaration of conformity. Thus, the form of the Declaration is free. Basic information to be provided in the Declaration: Name of medical device (s); Manufacturer's name; Name of production sites; Name of authorized representative; Product classification (all possible modifications); Conformity assessment procedure, number of the Technical Regulation; Information that the medical device meets the basic requirements of the relevant TR; Date and information about the person signing the declaration; Validity of the declaration of conformity; Link to version and technical file number (if applicable)