Recognition of EC certificates for medical devices and IVDs in Ukraine. Maksym Bagrieiev, Natalia Naumchuk. Cratia, Ukraine.

1
Recognition of EC certificates for medical
devices and IVDs in Ukraine
Maksym BAGRIEIEV, Managing Partner Natalia
NAUMCHUK, Key Account Manager December 6, 2019
2
Plan of webinar

• Technical regulations in Ukraine where we are
  now and how we got there
• National legislation Technical regulations and
  other legal acts
• Authorized representative in Ukraine
• Language and labeling requirements
• Conformity assessment bodies and international
  standards

40 min
3
Plan of webinar

• Technical regulations in Ukraine where we are
  now and how we got there
• National legislation Technical regulations and
  other legal acts
• Authorized representative in Ukraine
• Language and labeling requirements
• Conformity assessment bodies and international
  standards
• coffee break 10 minutes
• Conformity assessment procedures
• What problems can be solved by recognition
• Legal requirements for recognition in details
• List of notified bodies signed Agreements with UA
  CABs
• Step-by-step process

40 min
40 min
4
Plan of webinar

• Technical regulations in Ukraine where we are
  now and how we got there
• National legislation Technical regulations and
  other legal acts
• Authorized representative in Ukraine
• Language and labeling requirements
• Conformity assessment bodies and international
  standards
• coffee break 10 minutes
• Conformity assessment procedures
• What problems can be solved by recognition
• Legal requirements for recognition in details
• List of notified bodies signed Agreements with UA
  CABs
• Step-by-step process
• coffee break 10 minutes
• What should be considered prior to apply for
  recognition
• Impact of changes in EU to UA certificate
• Changes and renewals

40 min
40 min
40 min
5
We want your questions! Just type them to the
chat. Every 3-5 slides we will stop to check and
answer.
6
Speakers
Natalia NAUMCHUK Key Account Manager
Maksym BAGRIEIEV Managing partner
7
Speakers
Natalia NAUMCHUK Key Account Manager
Maksym BAGRIEIEV Managing partner
Max is a founder and CEO of Cratia Group, which
he started in 2006. Has over 15 years in
regulatory affairs, a number of publications in
specialized mass media. Max holds a bachelors
degree in economics and continues studying
quality certification as second education.

8
Speakers
Natalia NAUMCHUK Key Account Manager
Maksym BAGRIEIEV Managing partner
As the KAM Natalia oversees Cratias business
development in medical device industry. An expert
in national and EU legislation, with huge
experience in conformity assessment procedures
and strong analytical mind. Prior to Cratia
Natalia worked in RD at national medical device
manufacturers. Natalia holds a bachelors degree
in medical device design development, and
second degree in international economics.
Max is a founder and CEO of Cratia Group, which
he started in 2006. Has over 15 years in
regulatory affairs, a number of publications in
specialized mass media. Max holds a bachelors
degree in economics and continues studying
quality certification as second education.

9
Technical regulations in Ukraine where we are
now and how we got there
10
World Trade Organization
European Union
Ukrainian legislation
11
World Trade Organization
European Union
Ukrainian legislation
August 24, 1991 Independence
12
World Trade Organization
European Union
Ukrainian legislation
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
13
World Trade Organization
European Union
Ukrainian legislation
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
14
World Trade Organization
European Union
Ukrainian legislation
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
15
World Trade Organization
European Union
Ukrainian legislation
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
16
World Trade Organization
European Union
Ukrainian legislation
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
17
World Trade Organization
European Union
Ukrainian legislation
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
18
World Trade Organization
European Union
Ukrainian legislation
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
19
World Trade Organization
European Union
Ukrainian legislation
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
20
World Trade Organization
European Union
Ukrainian legislation
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
21
World Trade Organization
European Union
Ukrainian legislation
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
22
World Trade Organization
European Union
Ukrainian legislation
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
23
World Trade Organization
European Union
Ukrainian legislation
January 15, 2015 Law On technical regulations
and conformity assessment
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
24
World Trade Organization
European Union
Ukrainian legislation
June 1, 2015 Technical regulations on medical
devices became mandatory
January 15, 2015 Law On technical regulations
and conformity assessment
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
25
World Trade Organization
European Union
Ukrainian legislation
June 1, 2015 Technical regulations on medical
devices became mandatory
January 1, 2016 Agreement on free trade area
January 15, 2015 Law On technical regulations
and conformity assessment
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
26
World Trade Organization
European Union
Ukrainian legislation
December 6, 2019 we are here
June 1, 2015 Technical regulations on medical
devices became mandatory
January 1, 2016 Agreement on free trade area
January 15, 2015 Law On technical regulations
and conformity assessment
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
27
World Trade Organization
European Union
Ukrainian legislation
Agreements on Conformity Assessment and
Acceptance of Industrial Goods (ACAA)
December 6, 2019 we are here
June 1, 2015 Technical regulations on medical
devices became mandatory
January 1, 2016 Agreement on free trade area
January 15, 2015 Law On technical regulations
and conformity assessment
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
28
World Trade Organization
European Union
Ukrainian legislation
Ukraine joins EU
Agreements on Conformity Assessment and
Acceptance of Industrial Goods (ACAA)
December 6, 2019 we are here
June 1, 2015 Technical regulations on medical
devices became mandatory
January 1, 2016 Agreement on free trade area
January 15, 2015 Law On technical regulations
and conformity assessment
March 21 June 27, 2014 Agreement on
Association between Ukraine and EU (01.09.2017)
May 31, 2011 Ministry of Economy and Trade
June 2010 Agreement with European Free Trade
Association EFTA (from 01.06.2012)
May 16, 2008 Ukraine joined WTO
February 5, 2008 Ukraine signed Protocol on
joining WTO
December 1, 2005 Law On technical regulations
and conformity procedures
May 17, 2001 Laws On conformity assessment and
On accreditation of conformity assessment bodies
June 14, 1994 Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)
April 15, 1994 TBT Agreement
November 30, 1993 Official declaration of
Government of Ukraine to join GATT (WTO)
May 10, 1993 Decree On standardization and
certification
August 24, 1991 Independence
29
The Deep and Comprehensive Free Trade
Areas (DCFTA)
European Union      EFTA states participating in
the EU's internal market with exceptions Iceland,
 Liechtenstein, Norway, Switzerland      DCFTA
states with access to the EU's internal market in
selected sectors Georgia, Moldova, Ukraine
30
AGREEMENT ON TECHNICAL BARRIERS TO TRADE ("TBT
Agreement")
31
ASSOCIATION AGREEMENT between the European Union
and its Member States, of the one part, and
Ukraine, of the other part
32
ASSOCIATION AGREEMENT between the European Union
and its Member States, of the one part, and
Ukraine, of the other part
33
Progress and Results

1. Ukraine has cancelled tens of thousands GOSTs
   (USSR standards)

34
Progress and Results

1. Ukraine has cancelled tens of thousands GOSTs
   (USSR standards)
2. Ukraine has implemented 55 technical regulations,
   51 of them are developed based on the EU
   Directives, including directives of the New and
   Global Approaches

35
Progress and Results

1. Ukraine has cancelled tens of thousands GOSTs
   (USSR standards)
2. Ukraine has implemented 55 technical regulations,
   51 of them are developed based on the EU
   Directives, including directives of the New and
   Global Approaches
3. There are 114 notified bodies designated for
   conformity assessment of products

36
Progress and Results

1. Ukraine has cancelled tens of thousands GOSTs
   (USSR standards)
2. Ukraine has implemented 55 technical regulations,
   51 of them are developed based on the EU
   Directives, including directives of the New and
   Global Approaches
3. There are 114 notified bodies designated for
   conformity assessment of products
4. The National Accreditation Agency of Ukraine
   (NAAU) has obtained the status of signatory of
   the Bilateral Agreements on Recognition with the
   European co-operation for accreditation (EA) for
   accreditation of bodies engaged in certification
   of products, management systems and personnel,
   inspectorates, testing and calibration
   laboratories.

37
Progress and Results

1. Ukraine has cancelled tens of thousands GOSTs
   (USSR standards)
2. Ukraine has implemented 55 technical regulations,
   51 of them are developed based on the EU
   Directives, including directives of the New and
   Global Approaches
3. There are 114 notified bodies designated for
   conformity assessment of products
4. The National Accreditation Agency of Ukraine
   (NAAU) has obtained the status of signatory of
   the Bilateral Agreements on Recognition with the
   European co-operation for accreditation (EA) for
   accreditation of bodies engaged in certification
   of products, management systems and personnel,
   inspectorates, testing and calibration
   laboratories.
5. NAAU obtained the status of a full member of
   International Laboratory Accreditation
   Cooperation (ILAC) and become a signatory of ILAC
   Mutual Recognition Arrangement (MRA).

38
Progress and Results

1. Ukraine has cancelled tens of thousands GOSTs
   (USSR standards)
2. Ukraine has implemented 55 technical regulations,
   51 of them are developed based on the EU
   Directives, including directives of the New and
   Global Approaches
3. There are 114 notified bodies designated for
   conformity assessment of products
4. The National Accreditation Agency of Ukraine
   (NAAU) has obtained the status of signatory of
   the Bilateral Agreements on Recognition with the
   European co-operation for accreditation (EA) for
   accreditation of bodies engaged in certification
   of products, management systems and personnel,
   inspectorates, testing and calibration
   laboratories.
5. NAAU obtained the status of a full member of
   International Laboratory Accreditation
   Cooperation (ILAC) and become a signatory of ILAC
   Mutual Recognition Arrangement (MRA).
6. The NAAU is also a member of the International
   Accreditation Forum (IAF) and a signatory of a
   multilateral agreement (IAF MLA) covering the
   following fields certification of products
   ISO/IEC 17065, certification of personnel
   ISO/IEC 17024, certification of management
   systems ISO/IEC 17021-1 (ISO 9001 and ISO
   14001).

39

• At July 1, 2015 three Technical regulations
  became obligatory in Ukraine
• Technical regulation on medical devices, approved
  by Resolution of Cabinet of Ministers of Ukraine
  ?753 dated 02.10.2013
• Technical regulation on medical devices for in
  vitro diagnostic, approved by Resolution of
  Cabinet of Ministers of Ukraine ?754 dated
  02.10.2013
• Technical regulation on active implantable
  medical devices, approved by Resolution of
  Cabinet of Ministers of Ukraine ?755 dated
  02.10.2013.

40
Ukrainian Technical regulations are based on EU
Directives. General part of each Technical
regulation contains reference to relevant
Directive (That Technical regulation is based on
)
Council Directive 93/42/EEC of 14 June 1993
concerning medical devices
Technical regulation on medical devices, approved
by Resolution of Cabinet of Ministers of Ukraine
?753 dated 02.10.2013 Technical regulation on
medical devices for in vitro diagnostic, approved
by Resolution of Cabinet of Ministers of Ukraine
?754 dated 02.10.2013 Technical regulation on
active implantable medical devices, approved by
Resolution of Cabinet of Ministers of Ukraine
?755 dated 02.10.2013.
Directive 98/79/EC of the European Parliament and
of the Council of 27 October 1998 on in vitro
diagnostic medical devices
Council Directive 90/385/EEC of 20 June 1990 on
the approximation of the laws of the Member
States relating to active implantable medical
devices
41
Ukrainian Technical regulations are based on EU
Directives. General part of each Technical
regulation contains reference to relevant
Directive (That Technical regulation is based on
)
Council Directive 93/42/EEC of 14 June 1993
concerning medical devices
Technical regulation on medical devices, approved
by Resolution of Cabinet of Ministers of Ukraine
?753 dated 02.10.2013 Technical regulation on
medical devices for in vitro diagnostic, approved
by Resolution of Cabinet of Ministers of Ukraine
?754 dated 02.10.2013 Technical regulation on
active implantable medical devices, approved by
Resolution of Cabinet of Ministers of Ukraine
?755 dated 02.10.2013.
Directive 98/79/EC of the European Parliament and
of the Council of 27 October 1998 on in vitro
diagnostic medical devices
Council Directive 90/385/EEC of 20 June 1990 on
the approximation of the laws of the Member
States relating to active implantable medical
devices
42
Annex I Essential requirements Annex II Full
quality assurance system Annex III EC
type-examination Annex IV EC verification Annex V
Production quality assurance Annex VI Product
quality assurance Annex VII EC declaration of
conformity Annex VIII Statement concerning
devices for special purposes Annex IX
Classification criteria Annex X Clinical
evaluation Annex XI Criteria to be met for the
designation of notified bodies Annex XII CE
marking of conformity
Annex 1 Essential requirements to medical
devices Annex 2 Classification criteria of
medical devices Annex 3 Full quality assurance
system Annex 4 Type examination Annex 5 Product
verification Annex 6 Production quality
assurance Annex 7 Product quality assurance Annex
8 Internal production control Annex 9 Statement
concerning devices for special purposes Annex 10
Clinical evaluation Annex 11 National symbol of
conformity
43
Transition period of 2 years has been granted
Medical devices placed on the market before July
1, 2017 can be marketed until the expiry date,
but not more than 5 years from that date of
import. No additional specific actions should be
taken for these medical devices.
44
Despite UA Technical regulations are based on EU
Directives and overall similarity of the
conformity assessment systems, there are still
lots of national particularities and differences
45
(No Transcript)
46
Technical regulation on medical devices (Decree
753)
Technical regulation on medical devices for IVD
(Decree 754)
Technical regulation on active implantable
devices (Decree 755)
47
Technical regulation on medical devices (Decree
753)
Technical regulation on medical devices for IVD
(Decree 754)
Technical regulation on active implantable
devices (Decree 755)
48
Technical regulation on medical devices (Decree
753)
Technical regulation on medical devices for IVD
(Decree 754)
Technical regulation on active implantable
devices (Decree 755)
Law On accreditation of conformity assessment
bodies
Law of Ukraine On Technical regulations and
conformity assessment
Law of Ukraine On state market supervision and
control of non-food products
Law On general safety of non-food products
Law On protection of consumers rights
ISO/IEC 17025
ISO/IEC 17021
ISO/IEC 17065
Law On basis of state supervision (control) in
the economic activities
Law On ensuring the functioning of the Ukrainian
language as a state language
Decree N753 On approval of the list of state
market supervision authorities
Decree N1184 On approval of the form of national
symbol of conformity
IAF MD 5
IAF MD 9
Decree N647 On State Administration of Ukraine
on Medicinal Products and Control of Narcotics
Order of Ministry of Health N122 On approval of
the Order of filling the registry of entities
responsible for placing of medical devices and
forms
49
Technical regulations of Ukraine are based on EU
Medical Device Directives, but contain lots of
differences and implementation particularities
Foreign medical device manufacturer must
designate Authorized Representative in Ukraine
no such symbol!
50
Technical regulations of Ukraine are based on EU
Medical Device Directives, but contain lots of
differences and implementation particularities
Foreign medical device manufacturer must
designate Authorized Representative in Ukraine
no such symbol!
CE mark is not recognized. National conformity
symbol should be affixed to every individual
medical device.
51
Technical regulations of Ukraine are based on EU
Medical Device Directives, but contain lots of
differences and implementation particularities
Foreign medical device manufacturer must
designate Authorized Representative in Ukraine
no such symbol!
CE mark is not recognized. National conformity
symbol should be affixed to every individual
medical device.
Conformity assessment procedure should be
performed by national Ukrainian notified bodies.
UA.TR.000
52
Technical regulations of Ukraine are based on EU
Medical Device Directives, but contain lots of
differences and implementation particularities
Foreign medical device manufacturer must
designate Authorized Representative in Ukraine
no such symbol!
CE mark is not recognized. National conformity
symbol should be affixed to every individual
medical device.
Conformity assessment procedure should be
performed by national Ukrainian notified bodies.
UA.TR.000
Labeling of the medical device must be done in
Ukrainian language. List of other specific
labeling requirements apply.
and many others
53
Authorized representative in Ukraine
54
Non-resident manufacturers of medical devices
must designate Authorized representative in
Ukraine prior to placing of medical devices into
the market. Ukraine is not EU member state
(yet!). EU manufacturers must designate
Authorized representative in Ukraine.
Practically designation of Authorized
representative is the first step in national
conformity assessment process.
55
authorized representative - any legal entity or
natural person-entrepreneur that is resident of
Ukraine or incorporated under the laws of
Ukraine, representative of a foreign legal
entity, that has duly confirmed rights granted
from manufacturer to perform legal actions on its
behalf in relation to duties of manufacturer
Decree of Cabinet
of Ministers 753 dated October 02, 2013.
56
Legislation defines that exact type/model of
medical device must be associated with only one
Authorized representative. Manufacturer can
designate more than one Authorized representative
in Ukraine, but for different medical devices.
57

• Authorized representative
• Point of exchange of information between
• Manufacturer,
• Conformity assessment body, Market supervision
  authorities, fiscal and others,
• Consumers,
• Importers, distributors and other market
  operators.
• Place of keeping of Technical file and related
  documentation
• Legal entity that takes primary responsibility
  for safety and quality of medical device placed
  on the market of Ukraine
• Performs post-marketing activities
• Performs specific functions issue of different
  letters, authorizations, explanations.

58
Name and address of the Authorized Representative
must be placed on the labeling of each of the
medical device and/or in the instruction for use
59
Symbol of conformity
60
Symbol of national conformity
For conformity assessment routes without
conformity assessment body (class I medical
devices, group other for IVDs)
61
Symbol of national conformity
For conformity assessment routes without
conformity assessment body (class I medical
devices, group other for IVDs)
UA.TR.XXX is the format of affixing of
identification code (instead of XXX) of Ukrainian
conformity assessment body. Obligatory for all
procedures that involved such bodies.
62
Symbol of national conformity
Not less than 5 mm
Height of the symbol should be not less than 5
mm, however small-sized medical devices can
obtain exemption from that rule (according to our
experience requires relevant records in Technical
file).
63
Symbol of national conformity
Symbol should be affixed on every individual
medical device (minimum sale unit). NB! For
hospital packs.
64
Symbol of national conformity
Symbol should affixed on the medical device, or
its labeling and instruction for use (manual).
Symbol can be affixed to the label and on the
accompanying documents. Sticker is not
restricted. NB! For sterile medical devices.
65
Language and information
66
Ukraine has only one official language
Ukrainian. It is different from Russian, however
uses Cyrillic letters of alphabet. Labeling of
every individual medical device must be done in
Ukrainian language.
67

• Use of international symbols for medical devices
  labeling
• Where appropriate, information on labeling should
  take the form of symbols.
• Any symbol or identification colour used must
  conform to the harmonized standards.
• In areas for which no standards exist, the
  symbols and colours must be described in the
  documentation supplied with the device.

68

• Use of international symbols for medical devices
  labeling
• Where appropriate, information on labeling should
  take the form of symbols.
• Any symbol or identification colour used must
  conform to the harmonized standards.
• In areas for which no standards exist, the
  symbols and colours must be described in the
  documentation supplied with the device.
• DSTU EN 9802007 (EN 9802003, IDT) Graphical
  symbols for use in the labelling of medical
  devices
• DSTU ISO 15223-12015 (ISO 15223-12007, IDT)
  Medical devices Symbols to be used with medical
  device labels, labelling and information to be
  supplied Part 1 General requirements

69

• Obligatory labeling elements in addition to EU
  package
• Name of the medical device or identification
  data, in Ukrainian language. Trademark can be
  indicated in the language of given legal
  protection in Ukraine MicroCrat disposable
  medical syringe
• Package content or product description, in
  Ukrainian language.
• National symbol of conformity (if necessary -
  identification code of the body)
• Name and address of the Authorized representative
  of the manufacturer in Ukraine if not specified
  in the instructions for use mandatoryif
  specified in the instruction by decision of the
  manufacturer (recommended)
• Name and address of the manufacturer in the
  Ukrainian transliteration (in addition, we
  recommend to specify the address in Latin
  alphabet).
• Country of origin in the Ukrainian language
  (manufacturer in ...), if it differs from the
  country of legal manufacturer.

70
Example of sticker in addition to EU package
Product name and description in Ukrainian
????? ?????????? ???????????? ????????????
Tradename 1 ?? ? ?????? 30G x 1/2 in (0.3 x
13??)
Name and address of Authorized representative in
Ukraine
Symbol of conformity, with identification code
Symbol of manufacturer, name and address of
manufacturer in Ukrainian transliteration and in
English
Country of origin
71
Ukrainian conformity assessment bodies
72

• Ukrainian conformity assessment bodies are
  regulated with similar legal acts as in EU
• ISO/IEC 17021 Conformity assessment
  Requirements for bodies providing audit and
  certification of management systems
• ISO/IEC 17025 General requirements for the
  competence of testing and calibration
  laboratories
• ISO/IEC 17065 Conformity assessment
  Requirements for bodies certifying products,
  processes and services

73

• List of conformity assessment bodies is published
  at the website of Ministry of Economic
  Development and Trade. There are two lists of
  designations
• issued before February 20, 2016 (valid till July
  3, 2021)
• issued after February 20, 2016 (without expiry).

74
There are 13 conformity assessment bodies
designated for medical devices, both governmental
and private. Despite all bodies must follow
mentioned ISO/IEC standards, IAF Mandatory
Documents and applicable national legislation,
there are huge difference in competence of
experts and auditors, requirements to
documentation and translations, timelines, prices
and other aspects.
75
Coffee break 10 minutes!

• In the next chapter
• Conformity assessment procedures
• What problems can be solved by recognition
• Legal requirements for recognition in details
• List of notified bodies signed Agreements with UA
  CABs
• Step-by-step process.

76
National conformity assessment procedures
77
Annex I Essential requirements Annex II Full
quality assurance system Annex III EC
type-examination Annex IV EC verification Annex V
Production quality assurance Annex VI Product
quality assurance Annex VII EC declaration of
conformity Annex VIII Statement concerning
devices for special purposes Annex IX
Classification criteria Annex X Clinical
evaluation Annex XI Criteria to be met for the
designation of notified bodies Annex XII CE
marking of conformity
Annex 1 Essential requirements to medical
devices Annex 2 Classification criteria of
medical devices Annex 3 Full quality assurance
system Annex 4 Type examination Annex 5 Product
verification Annex 6 Production quality
assurance Annex 7 Product quality assurance Annex
8 Internal production control Annex 9 Statement
concerning devices for special purposes Annex 10
Clinical evaluation Annex 11 National symbol of
conformity
78
Self-declaration (Annex VIII), plus registration
at the competent authority
Class I (non-sterile, non-measuring)
IVD group others devices not under List A and
List B, not intended for self-control
Non-sterile class IIa, IIb and III medical devices
Procedures with audit
Batch certification procedure
OR
List B medical devices for in-vitro diagnostics
All sterile medical devices (class Is, IIa, IIb,
III)
List A medical devices for in-vitro diagnostics
Active implantable medical devices
IVD for self-control
Design examination
Presentation prepared by Cratia
www.cratia.ua
79
What is the problem with audit?
80
- Increased cost of initial, annual supervision
and recertification procedures - Stress to the
manufacturer - Competence of the auditors,
language problems - Risks of observations -
Length of the procedures - Small sense
considering UA harmonization with EU - Overwork
due to additional audit
81
Foreign manufacturers of medical devices faced a
lot of significant problems with regulatory
access of products to the Ukrainian market, while
political and economic situation was the most
unfavorable for business the cumulative drop in
GDP by more than 16 in 2014-2015, devaluation of
the local currency (hryvnia) by more than 300,
the antiterrorist operation in Eastern Ukraine,
decrease of public procurements, bankruptcy of
several national distributors of medical devices.
Overall situation was also influenced with the
skepticism of manufacturers related to the de
facto expiry of unlimited state registration
certificates for medical devices.
82
Obligatory implementation of Technical
regulations has been postponed twice. Medical
devices market has refused to apply for new
conformity assessment procedure that required
stressful and costly audits.
83
Recognition
84
Ministry of Economic Development and Trade has
developed, and Parliament of Ukraine has approved
Law of Ukraine On Technical regulations and
conformity assessment, effective from February
10, 2019. That Law is the main legal act in the
field of technical regulation of non-food
products of Ukraine. The Law defines legal and
organisational aspects of development, approval
and use of Technical regulations in Ukraine and
procedures of conformity assessment.
85
Article 45 of the Law describes several
procedures of recognition, including partial
recognition of EC certificates.
86
On June 6, 2019 amendments to the Law have came
into force strengthening and extending of the
recognition procedure.
87
Self-declaration (Annex VIII), plus registration
at the competent authority
Class I (non-sterile, non-measuring)
IVD group others devices not under List A and
List B, not intended for self-control
Non-sterile class IIa, IIb and III medical devices
Procedures with audit
Batch certification procedure
OR
List B medical devices for in-vitro diagnostics
All sterile medical devices (class Is, IIa, IIb,
III)
List A medical devices for in-vitro diagnostics
Active implantable medical devices
IVD for self-control
Design examination
Presentation prepared by Cratia
www.cratia.ua
88
Self-declaration (Annex VIII), plus registration
at the competent authority
Class I (non-sterile, non-measuring)
IVD group others devices not under List A and
List B, not intended for self-control
Non-sterile class IIa, IIb and III medical devices
Procedures with partial recognition of EC
certificate
List B medical devices for in-vitro diagnostics
All sterile medical devices (class Is, IIa, IIb,
III)
List A medical devices for in-vitro diagnostics
Active implantable medical devices
IVD for self-control
Presentation prepared by Cratia
www.cratia.ua
89
Benefits of recognition procedure

• Audit from national conformity assessment body
  can be avoided at initial, supervision,
  recertification and extension cases

Significant reduction of the expenses flight,
accommodation, fees
Faster approval timelines
Less risks related with assessment and
observations during audit
Easier assessment for class III medical devices /
List A IVDs / active implants
Avoiding of submission of confidential
information, for example for design examination
procedure.
90
NB! Recognition procedure is not unconditional
exchange of the EC certificate to UA certificate!
Recognition procedure has its specific
requirements and allows only partial recognition
of conformity assessment results performed by EU
notified bodies.
91

• Law of Ukraine On Technical regulations and
  conformity assessment
• Article 45. Recognition of the results of
  conformity assessment conducted outside Ukraine
• 1. The results of conformity assessment to the
  requirements of Technical regulations, carried
  out in another country, are recognized and
  accepted in Ukraine in case if the conformity
  assessment procedures in this country (even if
  they differ from the Ukrainian procedures) ensure
  the same or higher level of conformity with the
  requirements of the relevant technical
  regulations, as well as the Ukrainian conformity
  assessment procedures.
• 2. The results of conformity assessment (test
  reports, documents of conformity, etc.) to the
  requirements of technical regulations conducted
  in other states are recognized and accepted in
  Ukraine in accordance with the provisions of
  current international agreements of Ukraine on
  mutual recognition of the results of conformity
  assessment.
• 3. The notified bodies have the right to
  recognize and accept the results of conformity
  assessment (test reports, documents of
  conformity, etc.) to the requirements of
  technical regulations conducted by foreign
  accredited conformity assessment bodies on the
  basis of agreements on the recognition of
  conformity assessment results concluded with such
  notified bodies, provided that
• national accreditation bodies both in Ukraine and
  in other countries are members of international
  or regional accreditation organizations and/or
  signed an agreement on mutual recognition
  regarding the relevant types of conformity
  assessment activities
• the notified body based on the results of
  conformity assessment (test reports, conformity
  documents, etc.) conducted by the foreign
  notified body applies the procedure of conformity
  assessment or its part and issues a document of
  conformity provided by this procedure under its
  own responsibility.

92

1. The results of conformity assessment to the
   requirements of Technical regulations, carried
   out in another country, are recognized and
   accepted in Ukraine in case if the conformity
   assessment procedures in this country (even if
   they differ from the Ukrainian procedures) ensure
   the same or higher level of conformity with the
   requirements of the relevant technical
   regulations, as well as the Ukrainian conformity
   assessment procedures.

93

1. The results of conformity assessment to the
   requirements of Technical regulations, carried
   out in another country, are recognized and
   accepted in Ukraine in case if the conformity
   assessment procedures in this country (even if
   they differ from the Ukrainian procedures) ensure
   the same or higher level of conformity with the
   requirements of the relevant technical
   regulations, as well as the Ukrainian conformity
   assessment procedures.

Condition ?1 same level of conformity in Ukraine
and reference country
94

1. The results of conformity assessment to the
   requirements of Technical regulations, carried
   out in another country, are recognized and
   accepted in Ukraine in case if the conformity
   assessment procedures in this country (even if
   they differ from the Ukrainian procedures) ensure
   the same or higher level of conformity with the
   requirements of the relevant technical
   regulations, as well as the Ukrainian conformity
   assessment procedures.

Council Directive 93/42/EEC of 14 June 1993
concerning medical devices
Technical regulation on medical devices, approved
by Resolution of Cabinet of Ministers of Ukraine
?753 dated 02.10.2013 Technical regulation on
medical devices for in vitro diagnostic, approved
by Resolution of Cabinet of Ministers of Ukraine
?754 dated 02.10.2013 Technical regulation on
active implantable medical devices, approved by
Resolution of Cabinet of Ministers of Ukraine
?755 dated 02.10.2013.
Directive 98/79/EC of the European Parliament and
of the Council of 27 October 1998 on in vitro
diagnostic medical devices
Council Directive 90/385/EEC of 20 June 1990 on
the approximation of the laws of the Member
States relating to active implantable medical
devices
95
2. The results of conformity assessment (test
reports, documents of conformity, etc.) to the
requirements of technical regulations conducted
in other states are recognized and accepted in
Ukraine in accordance with the provisions of
current international agreements of Ukraine on
mutual recognition of the results of conformity
assessment.
96
2. The results of conformity assessment (test
reports, documents of conformity, etc.) to the
requirements of technical regulations conducted
in other states are recognized and accepted in
Ukraine in accordance with the provisions of
current international agreements of Ukraine on
mutual recognition of the results of conformity
assessment.
Such Agreement is Agreement on Conformity
Assessment and Acceptance of Industrial Products
(ACAA), that is a part of Association of Ukraine
and European Union.  
97
3. The notified bodies have the right to
recognize and accept the results of conformity
assessment (test reports, documents of
conformity, etc.) to the requirements of
technical regulations conducted by foreign
accredited conformity assessment bodies on the
basis of agreements on the recognition of
conformity assessment results concluded with such
notified bodies in case if
Condition ?2 Agreement between UA body and EU
notified body
98

• national accreditation bodies that perform
  accreditation of notified bodies both in Ukraine
  and in other countries are members of
  international or regional accreditation
  organizations and/or signed an agreement on
  mutual recognition regarding the relevant types
  of conformity assessment activities

99

• national accreditation bodies that perform
  accreditation of notified bodies both in Ukraine
  and in other countries are members of
  international or regional accreditation
  organizations and/or signed an agreement on
  mutual recognition regarding the relevant types
  of conformity assessment activities

Condition ?3 accreditation bodies of UA and
reference state are members of international
accreditation organization and/or signed mutual
recognition agreement
100

• national accreditation bodies that perform
  accreditation of notified bodies both in Ukraine
  and in other countries are members of
  international or regional accreditation
  organizations and/or signed an agreement on
  mutual recognition regarding the relevant types
  of conformity assessment activities

National accreditation body of Ukraine is
National Agency on Accreditation of Ukraine
(NAAU - www.naau.org.ua).
NAAU is an associate member of the European
Accreditation Cooperation (EA) and a signatory of
the Multilateral Agreement with the EA (MLA EA)
through the bilateral Recognition Arrangement (EA
BLA) in the areas of accreditation of testing and
calibration laboratories, product certification
bodies, certification bodies for management
systems, bodies on certification of personnel and
inspection bodies. EA recognized that all
activities of NAAU are in line with European
regulatory requirements for accreditation. Thus,
NAAU carries out activities recognized at the
level of the European Union.
101

• the notified body based on the results of
  conformity assessment (test reports, conformity
  documents, etc.) conducted by the foreign
  notified body applies the procedure of conformity
  assessment or its part and issues a document of
  conformity provided by this procedure under its
  own responsibility.

102

• the notified body based on the results of
  conformity assessment (test reports, conformity
  documents, etc.) conducted by the foreign
  notified body applies the procedure of conformity
  assessment or its part and issues a document of
  conformity provided by this procedure under its
  own responsibility.

Condition ?4 basis of the recognition procedure
is the conformity certificate Condition ?5 UA
body performs at least part of the conformity
assessment procedure Condition ?6 UA body
issues national certificate under its
responsibility
103

• the notified body based on the results of
  conformity assessment (test reports, conformity
  documents, etc.) conducted by the foreign
  notified body applies the procedure of conformity
  assessment or its part and issues a document of
  conformity provided by this procedure under its
  own responsibility.

Condition ?4 basis of the recognition procedure
is the conformity certificate Condition ?5 UA
body performs at least part of the conformity
assessment procedure Condition ?6 UA body
issues national certificate under its
responsibility
104
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
105
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?
?2 Agreement between UA body and EU notified body
106
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?
?2 Agreement between UA body and EU notified body
?3 accreditation bodies of UA and reference
state are members of international accreditation
organization and/or signed mutual recognition
agreement
107
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?
?2 Agreement between UA body and EU notified body
?3 accreditation bodies of UA and reference
state are members of international accreditation
organization and/or signed mutual recognition
agreement
?4 basis of the recognition procedure is the
conformity certificate
108
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?
?2 Agreement between UA body and EU notified body
?3 accreditation bodies of UA and reference
state are members of international accreditation
organization and/or signed mutual recognition
agreement
?4 basis of the recognition procedure is the
conformity certificate
?
?5 UA body performs at least part of the
conformity assessment procedure
109
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?
?2 Agreement between UA body and EU notified body
?3 accreditation bodies of UA and reference
state are members of international accreditation
organization and/or signed mutual recognition
agreement
?4 basis of the recognition procedure is the
conformity certificate
?
?5 UA body performs at least part of the
conformity assessment procedure
?6 UA body issues national certificate under
its responsibility
110
Agreements with EU notified bodies
111

• In early 2016 we have faced with many challenges,
  related with signing of the Agreements on
  recognition between EU and UA notified bodies
• absence of comprehensive understanding and
  interpretation of the procedure
• absence of the procedure in QMS of UA and EU
  bodies
• absence of draft of the Agreement
• unwillingness of several UA bodies to switch from
  audits
• low motivation of EU bodies to sign such
  Agreements
• low competence of UA bodies in communication with
  EU bodies
• significant legal efforts in approval and signing
  of the Agreement from both sides
• high load of EU bodies related to MDRs and
  Brexit.

112
First Agreement fall 2016, TÜV SÜD.
113
(No Transcript)
114
December 2019 EU notified bodies that signed
Agreements on recognition
0123 TÜV SÜD Product Service GmbH 0197 TÜV
Rheinland LGA Products GmbH 2274 TÜV NORD
Polska Sp. z o.o 0044 TÜV NORD CERT GmbH 0086
BSI Assurance UK Limited 2797 BSI The
Netherlands B.V. 0344 DEKRA
Certification B.V. 0124 DEKRA Certification
GmbH 0297 DQS Medizinprodukte GmbH 0426
ITALCERT S.r.l. 0476 Kiwa Cermet Italia
S.p.a. 1984 Kiwa Belgelendirme Hizmetleri A.S.
115
December 2019 EU notified bodies that signed
Agreements on recognition
0088 Lloyds Register Quality
Assurance LRQA 0477 Eurofins product testing
Italy S.r.l. 0413 Intertek Semko AB 0318
Agencia Española de Medicamentos y Productos
Sanitarios AEMPS 1014 Elektrotechnický
zkušební ústav, s.p. EZÚ 0459
LNE/G-MED 0494 SLG Prüf- und Zertifizierungs
GmbH 0543 Presafe Denmark A/S 2460
DNV GL Presafe AS 1370 Bureau Veritas
Italia S.P.A. 2195 Szutest Uygunluk
Degerlendirme A.S. 0051 IMQ ISTITUTO ITALIANO
DEL MARCHIO DI QUALITÀ S.P.A.
116
December 2019 EU notified bodies that signed
Agreements on recognition
0843 UL INTERNATIONAL (UK) LTD 0482 MEDCERT
GmbH 0653 National Evaluation Center of
Quality Technology in Health SA 1304 SIQ
Slovenian Institute of Quality and
Metrology 0483 MDC medical device
certification GmbH 0402 RISE Research
Institutes of Sweden AB 1434 Polish
Centre for Testing and Certification 0425
ICIM S.p.A. 2409 CE Certiso Orvos- és
Kórháztechnikai Ellenorzo és Tanúsító Kft.
117
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?
?2 Agreement between UA body and EU notified body
?3 accreditation bodies of UA and reference
state are members of international accreditation
organization and/or signed mutual recognition
agreement
?4 basis of the recognition procedure is the
conformity certificate
?
?5 UA body performs at least part of the
conformity assessment procedure
?6 UA body issues national certificate under
its responsibility
118
Lets summarize all conditions and check if they
are met
?1 same level of conformity in Ukraine and
reference country
?2 Agreement between UA body and EU notified body
?3 accreditation bodies of UA and reference
state are members of international accreditation
organization and/or signed mutual recognition
agreement
?4 basis of the recognition procedure is the
conformity certificate
?
?5 UA body performs at least part of the
conformity assessment procedure
?6 UA body issues national certificate under
its responsibility
119

• Condition ?5 UA body performs at least part of
  the conformity assessment procedure
• filling the Application, Technical file and
  national documentation
• submission of the Application
• conformity assessment, can be partially
  recognized
• signing of the Certification Agreement.

120
Annex I Essential requirements Annex II Full
quality assurance system Annex III EC
type-examination Annex IV EC verification Annex V
Production quality assurance Annex VI Product
quality assurance Annex VII EC declaration of
conformity Annex VIII Statement concerning
devices for special purposes Annex IX
Classification criteria Annex X Clinical
evaluation Annex XI Criteri