Recognition of EC certificatesfor medical devices and IVDs in Ukraine. Maksym Bagrieiev, Natalia Naumchuk

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

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

Plan of webinar:
=== 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

Plan of webinar:
• Step-by-step process;
• What should be considered prior to apply for recognition;
• Impact of changes in EU to UA certificate;
• Changes and renewals;
• Post-marketing activities;
• Other Technical regulations;
• Market supervision.
40 min
40 min
40 min

We want your questions!
Just type them to the chat.
Every 3-5 slides we will stop to check and answer.

Speakers:
Natalia NAUMCHUK
Key Account Manager
Maksym BAGRIEIEV
Managing partner

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 bachelor’s degree in economics
and continues studying quality & certification as
second education.

Speakers:
Natalia NAUMCHUK
Key Account Manager
As the KAM Natalia oversees Cratia’s 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
R&D at national medical device manufacturers.
Natalia holds a bachelor’s degree in medical device
design & development, and second degree in
international economics.
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 bachelor’s degree in economics
and continues studying quality & certification as
second education.

Technical regulations in Ukraine:
where we are now and how we got there

World Trade Organization European Union Ukrainian legislation

August 24, 1991: Independence

May 10, 1993: Decree “On standardization and
certification”

certification”
November 30, 1993: Official declaration of
Government of Ukraine to join GATT (WTO)

certification”
April 15, 1994: TBT Agreement

certification”
June 14, 1994: Agreement on partnership and
cooperation between UA and EU (effective from
01.01.1998)

certification”
01.01.1998)
May 17, 2001: Laws “On conformity
assessment” and “On accreditation of
conformity assessment bodies”

certification”
01.01.1998)
December 1, 2005: Law “On technical
regulations and conformity procedures”

certification”
01.01.1998)
February 5, 2008: Ukraine signed Protocol on
joining WTO

certification”
01.01.1998)
joining WTO
May 16, 2008: Ukraine joined WTO

certification”
01.01.1998)
joining WTO
June 2010: Agreement with European Free
Trade Association EFTA (from 01.06.2012)

certification”
01.01.1998)
joining WTO
May 31, 2011: Ministry of Economy and Trade

certification”
01.01.1998)
joining WTO
March 21 – June 27, 2014: Agreement on
Association between Ukraine and EU (01.09.2017)

certification”
01.01.1998)
joining WTO
January 15, 2015: Law “On technical
regulations and conformity assessment”

certification”
01.01.1998)
joining WTO
June 1, 2015: Technical regulations on medical
devices became mandatory

certification”
01.01.1998)
joining WTO
January 1, 2016: Agreement on free trade area

certification”
01.01.1998)
joining WTO
December 6, 2019: we are here

certification”
01.01.1998)
joining WTO
Agreements on Conformity Assessment and
Acceptance of Industrial Goods (ACAA)

certification”
01.01.1998)
joining WTO
Agreements on Conformity Assessment and
Acceptance of Industrial Goods (ACAA)
Ukraine joins EU

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

AGREEMENT ON TECHNICAL BARRIERS TO TRADE
("TBT Agreement")

ASSOCIATION AGREEMENT
between the European Union and its Member States, of the one part,
and Ukraine, of the other part:

1. Ukraine has cancelled tens of thousands GOST’s (USSR standards);
Progress and Results

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).

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).

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.

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 …”):
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
Technical regulation on active implantable medical
devices, approved by Resolution of Cabinet of Ministers
of Ukraine №755 dated 02.10.2013.
Council Directive 93/42/EEC of 14 June 1993
concerning medical devices
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

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

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.

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

Technical regulation on
medical devices (Decree 753)
medical devices for IVD (Decree 754)
active implantable devices (Decree 755)

medical devices (Decree 753)
medical devices for IVD (Decree 754)
active implantable devices (Decree 755)
Law “On accreditation of
conformity assessment
bodies”
ISO/IEC
17025
ISO/IEC
17021
ISO/IEC
17065
IAF
MD 5
IAF
MD 9
Law of Ukraine “On Technical
regulations and conformity
assessment”
Law “On basis of state supervision
(control) in the economic activities”
Law of Ukraine “On state market
supervision and control of non-food
products”
Law “On ensuring the functioning of the
Ukrainian language as a state language”
Law “On protection
of consumer’s rights”
Law “On general safety of
non-food products”
Decree N753 “On approval of the list of
state market supervision authorities”
Decree N1184 “On approval of
the form of national symbol of
conformity”
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”

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

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…

Authorized representative in Ukraine

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.

“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.

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.

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

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:

Symbol of national conformity:
For conformity assessment routes
without conformity assessment body
(class I medical devices, group “other”
for IVD’s)

For conformity assessment routes
without conformity assessment body
(class I medical devices, group “other”
for IVD’s)
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.

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).

Symbol should be affixed on every individual medical device
(minimum sale unit).
NB! For “hospital” packs.

Symbol should affixed on the medical device, or it’s 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.

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.

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.

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 980:2007 (EN 980:2003, IDT) Graphical symbols for use in the labelling of
medical devices
DSTU ISO 15223-1:2015 (ISO 15223-1:2007, IDT) Medical devices — Symbols to be
used with medical device labels, labelling and information to be supplied — Part 1:
General requirements

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 – mandatory;
if 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.

Example of sticker in addition to EU package:
Шприц ін’єкційний одноразового використання Tradename®
1 мл з голкою 30G x 1/2 in (0.3 x 13мм)
Product name and description in Ukrainian
Symbol of
conformity, with
identification code
Name and address
of Authorized
representative in
Ukraine
Symbol of manufacturer, name and
address of manufacturer in Ukrainian
transliteration and in English
Country of origin

Ukrainian conformity assessment bodies

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

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).

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.

Coffee break 10 minutes!
In the next chapter:
• Step-by-step process.

National conformity assessment procedures

Self-declaration (Annex VIII),
plus registration at the competent
authority
Class I (non-sterile, non-measuring)
Non-sterile class IIa, IIb and III medical devices
Procedures with
audit
All sterile medical devices (class Is, IIa, IIb, III)
IVD group “others”: devices not under List A
and List B, not intended for self-control
List B medical devices for in-vitro diagnostics
List A medical devices for in-vitro diagnostics
Active implantable medical devices
IVD for self-control Design examination
Batch
certification
procedure
OR

What is the problem with audit?

- 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

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.

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.

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.

Article 45 of the Law describes several procedures of recognition,
including partial recognition of EC certificates.

On June 6, 2019 amendments to the Law have came into force strengthening and
extending of the recognition procedure.

Self-declaration (Annex VIII),
plus registration at the competent
authority
Class I (non-sterile, non-measuring)
Non-sterile class IIa, IIb and III medical devices
Procedures with partial
recognition of EC certificate
All sterile medical devices (class Is, IIa, IIb, III)
IVD group “others”: devices not under List A
and List B, not intended for self-control
List B medical devices for in-vitro diagnostics
List A medical devices for in-vitro diagnostics
Active implantable medical devices
IVD for self-control

Audit from national conformity assessment body can be avoided at initial,
supervision, recertification and extension cases;
Avoiding of submission of confidential information, for example – for design
examination procedure.
Less risks related with assessment and observations during audit;
Benefits of recognition procedure:
Significant reduction of the expenses: flight, accommodation, fees;
Faster approval timelines;
Easier assessment for class III medical devices / List A IVD’s / active implants;

NB! Recognition procedure is not unconditional exchange of the EC certificate to
UA certificate!
Recognition procedure has it’s specific requirements and allows only partial
recognition of conformity assessment results performed by EU notified bodies.

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.

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

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
Technical regulation on active implantable medical
devices, approved by Resolution of Cabinet of Ministers
of Ukraine №755 dated 02.10.2013.
Council Directive 93/42/EEC of 14 June 1993
concerning medical devices
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

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.
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 in case if:
Condition №2: Agreement between UA body and EU notified body

• 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

Condition №3: accreditation bodies of UA and reference state are members of international
accreditation organization and/or signed mutual recognition agreement

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.

• 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 it’s responsibility
• 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.

Let’s 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
?

№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 it’s responsibility
?
?

Agreements with EU notified bodies

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 MDR’s and Brexit.

First Agreement: fall 2016, TÜV SÜD.

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.Ş.

0088 Lloyd’s 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 Değerlendirme A.Ş.
0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

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 Ellenőrző és Tanúsító Kft.

?

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.

Chosen conformity assessment route in EU must be mirrored in Application for
recognition in Ukraine. That will allow UA notified body to perform assessment of
one part of the conformity assessment procedure and recognise second part
previously performed by EU notified body.

Minimum scope of conformity assessment performed by UA notified body under
recognition procedure:
- validity and scope of EC certificate and Application;
- reference to national procedures;
- designation of the Authorized representative: scope, rights and obligations, post-
marketing and vigilance etc.
- national Essential Requirements checklist;
- national language and labeling requirements;
- national IFU;
- national Declaration of conformity.

Step 1: Preliminary analysis: scope of EC certificate,
availability of the Agreement on recognition and choice of the
UA notified body, discussion of terms and conditions, list of
necessary documents etc.

Step 1: Preliminary analysis: scope of EC certificate,
availability of the Agreement on recognition and choice of the
UA notified body, discussion of terms and conditions, list of
necessary documents etc.
1. Preliminary analysis

Step 2: Designation of the Authorized representative:
Agreement and/or Power of Attorney.
2. Authorized representative

Step 3: Filling the initial necessary documents:
• EC certificate(s);
• EU DoC(s);
• Open part of the Technical file;
• Quality manual;
• Labeling and instruction for use.
3. Filling initial documents

Step 4: Translations and filling the national documents:
• Application form: procedure identical to EU route;
• Labeling;
• Instruction for use (manual);
• Essential Requirements check-list;
• draft of the Ukrainian Declaration of conformity;
• cover letters etc.
4. Ukrainian documents and forms

Step 5: Submission of the Application, signing of the
Agreement for conformity assessment and Certification
Agreement, making payments
5. Submission and payments

Step 6: Start of the assessment, communication with notified
body, answers on the deficiencies
6. Assessment and answers

Step 7: Specific procedures related to terms of the
Agreement between EU and UA bodies: inquiry from the
manufacturer, delivery of the assessment report, issue of the
specific letter etc.
Some EU notified bodies charge for these actions.
7. Specific procedures

Step 8: UA notified body prepares report on the assessment
procedure and issues draft of the certificate for review and
approval
8. Report and draft of certificate

Step 9: UA notified body issues national conformity
certificate
9. Issue of the certificate

Step 10: Manufacturer or Authorized representative can
now issue the Declaration of conformity and affix national
symbol of conformity to medical devices
10. DoC and affixing the symbol

Step 11: Maintenance of the registration:
• keeping the documents at Authorized representative;
• notifying on changes;
• annual supervisions and re-certifications;
• vigilance reporting;
• market supervision.
10. DoC and affixing the symbol
11. Maintenance and post-marketing

Coffee break 10 minutes!
In the next chapter:
• What should be considered prior to apply for recognition;
• Impact of changes in EU to UA certificate;
• Changes and renewals;
• Post-marketing activities;
• Other Technical regulations;
• Market supervision.

Choose conformity assessment route carefully

Recognition has its obvious benefits, but there are many things to be considered prior
to making the decision.
There is no simple switch between “classical” procedure with audit and recognition
procedure, that can be performed through withdrawal of the existing certificate and
submission of new Application.

Particularity №1. Since Ukrainian certificate is issued on the basis of EU certificate, it
absorbs all characteristics and restrictions, including:
• validity of the certificate;
• scope and product names;
• manufacturing sites;
• conformity assessment route(s).

Particularity №2. Whatever happens with EC certificate (changes, renewal,
withdrawal etc.) – that should be reflected in UA certificate asap.
NB! Always check and follow your Certification agreement with conformity
assessment body, be aware in timelines and conditions to maintain your certification.

Particularity №3. One EC certificate = one UA certificate.

Particularity №4. EU notified bodies can charge for issue of the letters or delivery of
the documents (reports, communication etc.) required for recognition.

Particularity №5. All national Ukrainian requirements must be fulfilled, including:
- designation of the Authorized representative;
- keeping all documents at Authorized representative for at least 5 years;
- language and labeling;
- issue of national DoC;
- conformity with all applicable Technical regulations (RoHS2, RED);
- activities to maintain your certification.

Impact of changes in EU to UA certificate

NB! For each certificate legal manufacturer signs Certification Agreement with
Ukrainian conformity assessment body. According to the terms of the Certification
Agreement all changes must be notified within specific timelines (usually 30 days,
but depends on changes).

Ukrainian certificate under procedure with partial recognition is linked with EU
certificate. Any changes to the EU certificate must be immediately applied in Ukraine,
including:
• exclusion of the products;
• split of the certificate;
• re-certification / renewal (for example MDR case);
• new manufacturing sites;
• changes of the product codes;
• transfer to another EU notified body.

Extension of the product line can be applied during planned supervision /
recertification. However…

recertification.
However, in case if EC certificate has been revised, new products under
supervision / recertification should be added by the separate Application to UA
notified body.

recertification.
However, in case if EC certificate has not been revised and the scope of EC
certificate already covers new products, manufacturer can extend UA DoC without
applying for changes to UA certificate. In that case notification to Ukrainian
conformity assessment body is still required.

Introduction of changes, variations

Technical regulation:
- It is the obligation of the manufacturer to notify on changes, related to chosen
conformity procedure;
Certification agreement (ISO/ IEC 17065: 2012):
- all changes that may affect the certificate are critical;

Take care of your Authorized representative and distributor: even minor changes
that do not affect the Certificate, but affect the product can have an impact on the
products placement on the market.

NB! EU notified body is not obligated to inform UA notified body on changes: that is
the obligation of the manufacturer!
NB2! Read and consider your Certification agreement!

Regular validity of Ukrainian certificate issued by the results of audit is 5 years,
according to ISO/IEC 17021.
But during recognition procedure Ukrainian certificate absorbs all characteristics of
EC certificate, as well as expiry date.

I
I I I
I
I
Validity of EC certificate: 5 years.
For example, EC certificate has been issued at November 1, 2017.
Certificate valid till October 31, 2022.

I
I I I
I
I
Validity of EC certificate: 5 years.
For example, EC certificate has been issued at November 1, 2017.
Certificate valid till October 31, 2022.
Ukrainian certificate issued at December 6, 2019 by
partial recognition procedure will have the same validity
till October 31, 2022.

After renewal of EC certificate for the next 5 years, Ukrainian certificate can be also
renewed for the same validity of 5 years.

NB! Gap risk: without renewed EC certificate it is not possible to finish Ukrainian
recertification procedure (example - Brexit case).

NB! In case if re-certification has been performed in EU for any reason, manufacturer
must inform UA conformity assessment body and apply for re-certification procedure
in Ukraine (example - MDR case).

Other applicable Technical regulations

By affixing symbol of conformity manufacturer takes responsibility that
requirements of all applicable Technical regulations will be met.
Responsibility is at the manufacturer’s side.

Medical devices are frequently objects of following Ukrainian Technical regulations:
- Technical regulation on restriction of hazardous substances in electronic and
electrical equipment, approved by Resolution 139 (RoHS2);
- Technical regulation on radio equipment, approved by Resolution 355 (RED).

Ukrainian Technical regulations are based on EU Directives:
UA RoHS2 Directive 2011/65/EU of the European Parliament and of the
Council of 8 June 2011
UA RED Directive 2014/53/EU of the European Parliament and of the
Council of 16 April 2014
however…

Both Technical regulations require:
- performing of national conformity assessment procedure;
- issue of national DoC to the national Technical regulation (both include forms);
- affixing specific information on the labeling;
- performing of specific actions on the market.
and can have indirect impact on the medical conformity assessment procedure.

UA RoHS2 conformity assessment procedure:
- designate Authorized representative;
- fill in the Technical documentation;
- perform procedure of internal quality control;
- manufacturer issues the DoC* (Annex 5);
- affix national symbol and name of the importer to the labeling;
- DoC should accompany the product through the supply chain.

UA RED difference from EU RED:
Essential requirements to RED devices include:
point 6: safety (LWE) and compatibility (EMC);
point 7: use of radio resource;
point 8: specific requirements.
Same as in EU.

Annex 1 (internal quality control): conformity to points 6, 7 and 8 (ER) is
demonstrated by compliance with relevant harmonized standards.
Annex 2 (type examination + internal quality control): notified body body performs
assessment of design dossier and issues type examination certificate.
Annex 3 (full quality assurance): notified body body performs audit of the site and
issues certificate of conformity.

160 standards

160 standards 15 standards

Annex 1 (internal quality control): conformity to points 6, 7 and 8 (ER) is
demonstrated by compliance with relevant harmonized standards.
Annex 2 (type examination + internal quality control): notified body body performs
assessment of design dossier and issues type examination certificate.
Annex 3 (full quality assurance): notified body body performs audit of the site and
issues certificate of conformity.
There are no harmonized standards under
UA RED Technical regulations to demonstrate
point 6: safety (LWE) and compatibility (EMC);
point 8: specific requirements.

UA RED conformity assessment procedure:
- designate Authorized representative;
- fill in the Technical documentation;
- submit the Application to UA notified body;
- notify body performs conformity assessment procedure;
- manufacturer issues the DoC* (Annex 5 to RED);
- affix national symbol and name of the importer to the labeling;
- DoC should accompany the product through the supply chain.

UA DoC to several Technical regulations
Law “On Technical regulations and conformity assessment” defines that in case if
product falls under several Technical regulations, manufacturer shall draw single
Declaration of conformity that can have the format of the dossier.

Market supervision and vigilance

Medical devices are object of market supervision.
Technical regulations put obligations on manufacturer regarding vigilance.
Competent authority is the State Administration of Ukraine on medical products and
control of narcotics.

Are there any rules?
- Law of Ukraine on General safety of non-food products;
- Law of Ukraine on State market surveillance and control of non-food products;
- Law of Ukraine About the appeal of citizens;
- Technical regulation on medical devices;
- MEDDEV 2.12-1;
- Certification agreement.

Safety monitoring - you are not alone!

Who are involved?
- Manufacturer
- Authorized representative
- Distributors
- Conformity assessment body
- Competent authority
- Users
All accidents have to be duly investigated and assessed.

Who are involved?
- Manufacturer
- Authorized representative
- Distributors
- Conformity assessment body
- Competent authority
- Users
All accidents have to be duly investigated and assessed.
Do not forget to inform

Information to competent authority: field safety actions and
withdrawals:

UA authority monitors foreign competent bodies:

17-21 Baggovutivska str., 6th floor,
04107, Kyiv, Ukraine
Tel: +38 044 364 33 55
+38 044 361 48 28
Corporate website:
https://cratia.ua/
info@cratia.ua
Authorized representative website:
http://uarep.com/
info@uarep.com

Recognition of EC certificatesfor medical devices and IVDs in Ukraine. Maksym Bagrieiev, Natalia Naumchuk

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