AGENDA: - How did martial law influence the market of medical devices in Ukraine? - How is the registration process for medical devices is organized in Ukraine? - Is it possible to recognize an MDR CE certificate?

1. RECOGNITION OF CE CERTIFICATES ON MD IN UKRAINE.
REGISTRATION PROCEDURE DURING MARTIAL LAW
Vladyslav Kasianenko
Audotor at Improve Medical CAB

3. The market of medical devices in Ukraine
Before russian ivasion (24 of February, 2022) After russian ivasion (24 of February, 2022)
Stable growing market of medical devices expands
the opportunities for manufacturers, distributors,
customers and for state in general.
Still stable, still growing, but with changing diversity
(more MD for military and emergency treatment),
increasing cost of final product etc
Project for adaptation of requirements of MDR to
Ukrainian Regulation (now we have Technical
Regulation Equivalent to MDD)
The project is delayed on uncertain period
Ukrainian manufacturers and other economic
operators started to integrate the requirements of
MDR into their QMS and applied to EU NB.
All applications are paused until the end of martial
law.
Part of medical devices in Medicinal/Pharmaceutical
basket reached 8,5%
Full uncertainty

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. Decree № 389 dated 29.03.2022

6. Decree № 389 dated 29.03.2022
To establish that for the period of martial law the introduction to the market of all medical devices, for which
the requirements of the Technical Regulation approved by this resolution are not met, is allowed if Ukrainian
conformity assessment body recognizes the results of conformity assessment performed by foreign
conformity assessment body in accordance with the requirements of parts one and three of Article 45 of the
Law of Ukraine “On Technical Regulations and Conformity Assessment”.

7. Law of Ukraine "On Technical Regulations and ConformityAssessment"
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.

8. Law of Ukraine "On Technical Regulations and ConformityAssessment"
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.

9. 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)

10. 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

11. List of documents attached to the application for conducting
conformity assessment procedure (on-site audit)

12. List of documents attached to the application for conducting
conformity assessment procedure (on-site audit)

13. 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

14. 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".

15. List of documents attached to the application for conducting
conformity assessment procedure (recognition procedure)

16. The conformity assessment body Improve Medical has simplified
the list of necessary documentation for the recognition of CE
certificates during martial law.
This decision was made in order to let the high quality medical
devices enter the marker more fast.

17. List of documents attached to the application for conducting
conformity assessment procedure (recognition during martial law)

18. List of documents attached to the application for conducting
conformity assessment procedure (recognition during martial law)

19. 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)

20. 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

21. Example of filled in checklist

22. .
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 studied 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)

23. 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.

24. 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)

25. Confirmation letter / Email / Screenshot
from NB website