20210610 - 1차 의료기기 해외GMP 인증과정 교육 - 엄수혁 - 배포용

MDR 규제요구사항과
MDR 의료기기 품질경영시스템

SOO HYUK UHM (Brian), CDT, PhD., in Dentistry
Technical Reviewer of Global Certificate Unit (Norway)
MDR Senior Technical Document Assessor
MDR Senior Clinical Assessor
MDR Lead Auditor
SPEAKER
2017/746 EU MDR QMS
MDR Lead Auditor
2021-06-10
SPEAKER [DNV]
[Background]
• DNV, Norway, Oslo / NON-ACTIVE TECHNICAL REVIEW TEAM (2y’ 2019~2021 현재)
• DNV, Korea, Seoul / MEDICAL TEAM (7y’ 2015~2021 현재)
• 연세대학교 치과대학 박사후 과정 연수 (2년 연수)

엄 수 혁, 치의학박사 • 연세대학교 치과대학 치의학 박사 졸
(Uhm, Soo Hyuk / Ph.D., in Dentistry) • 치과기공사 면허소지 및 임상경력보유
• 신한대학교 치기공학과 보건학사
• 경희대학교 환경응용화학부(화학공학)
[Research]
• 임플란트/생체재료 전임상/임상 연구관련논문 SCI/E 20편 저술
• 식약처/연구재단/산자부 등 23건의 국책과제수행 (연구원/연구책임)
• 국제학술대회 대상 연구수상 5 회
[Activity]
• 현, 외래교수 / 연세대학교 치과대학 치과생체재료공학교실 및 연구소
• 현, 치과의료기기 부작용 인과관계 조사관(의료기기법 제43조) / 한국의료기기안전정보원
• 현, 대한치과재료학회지 논문 편집위원 및 심사원
• 현, 강사 (대학원 강의과목: 글로벌 의료기기 허가 및 규제) /서울대학교 의료기기 산업학과
• 현, ISO TC 194: Biocompatibility 대한민국 전문위원 (COSD: KTR)
- WG4: Clinical investigation; GCP (ISO14155)
- WG10: Implantation (ISO10993-10)
- WG15: Strategic approach to biological assessment (ISO10993-1)
• 현, 규제강사, RA자격 교재 편집위원 / 한국의료기기안전정보원
• 현, 규제강사 / 한국의료기기공업협동조합, 치과의료기기산업협회
www.dnv.com
3 DNV ©
SPEAKER [DNV 소속]
• DNV, Norway, Oslo / NON-ACTIVE TECHNICAL REVIEW TEAM
• DNV, Korea, Seoul / MEDICAL TEAM
엄 수 혁, 치의학박사 [심사 자격]

• TECHNICAL REVIEWER (CE certifier) / Norway Team (인증기술검토원)
(Uhm, Soo Hyuk / Ph.D., in Dentistry)
- 93/42/EEC All non-active & non-implantable medical device
• 2017/745 MDR Senior Technical Document Assessor (~2b등급 기술문서심사원)

- non-active non-implantable medical device
- non-active implantable medical device
- non-active re-useable surgical instrument
- Gamma/EO/Steam/Plasma/Aseptic process
• 2017/745 MDR Senior Clinical Document Assessor (임상자료 기술문서심사원)

- non-active non-implantable medical device (Dental Materials)
- non-active implantable medical device (Dental Implants)
- non-active re-useable surgical instrument (Dental Instrument)
- non-active Class III implantable customized device (Dental implants)
• 2017/745 MDR QMS Lead Auditor / ISO13485:2016 LEAD AUDITOR (품질시스템 선임심사원)
- All non-active & non-implantable medical device
- Covered MDT CODE:
Metal/Ceramic/Plastic/Chemical/Cleanroom/Packaging/Reprocessing
- Gamma/EO/Steam/Plasma/Aseptic process
www.dnv.com
• MDD Class III Technical Document and QMS Specialist
(3등급 기술문서/품질시스템 심사원)
4 DNV ©
- All Dental device and Customized device
An introduction to DNV
2017/746 EU MDR QMS
MDR Lead Auditor
2021-03-18
Norway, Oslo HQ
DNV ©
Norway, Oslo HQ
https://www.dnvgl.com/about/name-
change-faq.html
Oslo, Norway, 13 January 2021 – DNV GL, the assurance and risk
management company, will change its name to DNV on 1 March
2021. The move comes after a comprehensive review of the
company’s strategy as it positions itself for a world in which many
of DNV’s markets are undergoing fundamental change.
DNV ©
A global assurance and risk management company
156 12,000 100,000 100+ 5% R&D

years employees customers countries of annual revenue
Ship and offshore Energy advisory, Software and Management system

classification and certification, digital solutions certification,
advisory verification and supply chain and
monitoring product assurance
DNV ©
Our purpose Our vision
To safeguard life, A trusted voice

property, and the to tackle global tr
environment ansformations
9 DNV ©
Our strategic research and development focus
Digital Assurance Energy Maritime

• Assurance of digital assets • Energy Transition Outlook • Digital class
• Model-based assurance • Assurance of digital power assets • Autonomous ships
• Computer vision • Renewables • Zero Carbon fuels
• Simulation & testing technologies • Low-carbon value chains
• Inspection technologies
Ocean Space Health Care Future Assurance Business

• Ocean Forecast • Data sharing in precision medicine • Assurance of precision food
• Aquaculture • Assurance of medical technologies • Assurance of circularity and sustainability claims
• New ocean value chains • Assurance of supply chain transparency and resilience
10 DNV ©
Presenting the outlook to guide strategic decisions
Industry Technology Ocean Energy Transition

Outlook Outlook Forecast Outlook
– the oil & gas industry outlook – the technology landscape – a forecast for the new – independent forecast of
for the year ahead of the next decade ocean economy energy demand and supply
2021 2030 2050 2050
DNV ©
Our vision
A trusted voice to tackle gl

obal transformations
www.dnv.com
12 DNV ©
DNV MEDICAL
13 DNV ©
Medical HQ
DNV ©
Medical Certification Service
Medical Devices
Ensuring safety and performance of medical devices critical to patient care in Europe
and beyond.
The Medical Device The Medical Devices Quality Management System Medical Device Single Audit
Regulation (EU) 2017/745 Directive (MDD) and In-Vitro for medical devices Program (MDSAP)
(MDR) Diagnostic Devices Directive (ISO 13485:2016)
(IVD)
15 DNV ©
MDR NOTIFIED BODY
https://ec.europa.eu/growth/tools-databases/nando
2021.02.23
16 DNV ©
Medical Certification Service Notified Body 2460
(2021 Mar~) DNV Product Assurance AS
(~2021 Feb) DNV GL Presafe AS
A Brief History:
• Formed in 2012 as a joint-venture
combining resources of two Oslo-based
Notified Bodies DNV GL 0434 and Nemko
0470
• MDD Notification in 2017 transferring all
active certificates from legacy owners to
2460
• 100% DNV GL ownership from June 2018
• MDR Notification in 2020
Future Designation Plans:

• MDSAP Authorization expected mid-2020
• Targeted IVDR Notification late 2021
DNV Medical Office, Hø vik, Oslo
17 DNV ©
의료기기의 유럽인증 제도
SOO HYUK UHM, Ph.D., in Dentistry

MDR TF Principle Assessor
MDR Clinical Assessor
MDR QMS Lead Auditor
18 DNV GL © SAFER, SMARTER, GREENER

MDR CE Marking
DNV GL ©
19
MDR NoBo 자격부여 프로세스


MDR-NoBo Authorities audit process
21 DNV GL ©
MDR-NoBo Authorities audit process
EU MEDICAL DEVICE SYSTEM

under MDR
Regulation system Regulatory BODY

MEDICAL DEVICE REGULATION
the European
(EU) 2017/745 Commission
MDR JOINT
(93/42/EEC MDD)
AUDIT team
MDCG Guidance
National Competent Basically 50 Mandays
documents Delegating Acts
Authorities (NCA) on-site
(MEDDEV Guidance)
EN Harmonized standards
Implementing Acts MDR Notified body
Common specification
22 DNV GL ©
MDR NoBo 자격 확인 및 검토 프로세스


MDD-NoBo
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MDD-NoBo
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
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MDD-NoBo
Current survived NBs under MDD: 55
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MDR DESIGNATED-NB
https://ec.europa.eu/growth/tools-
databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
27 DNV GL ©
MDR DESIGNATED-NB
https://ec.europa.eu/growth/tools-
databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
2021.06.02
28 DNV GL ©
IVDR DESIGNATED-NB
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MDR DESIGNATED-NB
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MDR DESIGNATED-NB
31 DNV GL ©
TEAM-NB


TEAM-NB
Click
http://www.team-nb.org/
33 DNV GL ©
TEAM-NB (The European Association for Medical device of Notified bodies)
34 DNV GL ©
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MDR 심사 프로세스


Summary MDR Conformity Assessment Process
Initial Application
Recertification
MDR Unannounced Audits

Min. 1 every 3 years Class III, IIb. 1 every 5 other classes.
MDR Audit MDR Audit Certification MDR Annual MDR Annual MDR Annual MDR Annual
Stage 1 Stage 2 Decision Surveillance 1 Surveillance 2 Surveillance 3 Surveillance 4
MDR Quality Management Audit
MDR Technical MDR Technical Documentation

Documentation
Continued assessment for sampled Class Is/Im/Ir, IIa and selected IIb
Assessment
(Including Clinical)
Min. 1 sample per product

group IIb and below
No sampling permitted for

Class III and selected IIb
MDR Technical Documentation Assessment
MDR Application MDR Certification

Form Process
38 DNV GL ©
BY TF ASSESSMENT TEAM : Assessor, Trainee-Assessor, Clinical Assessor
MDR Audit Stage 1 TF ASSESSMENT

TECHNICAL REVIEW CERTIFICATEION
MDR Audit Stage 2 QMS AUDIT (Global certificate unit; GCU/HQ) (Global certificate unit; GCU/HQ)
BY QMS AUDIT TEAM : LEAD AUDITOR/AUDITOR/TRAINEE-AUDITOR/TRAINEE-LEAD AUDITOR
39 DNV GL ©
Initial Application
Recertification
MDR Unannounced Audits

Min. 1 every 3 years Class III, IIb. 1 every 5 other classes.
MDR Audit MDR Audit Certification MDR Annual MDR Annual MDR Annual MDR Annual
Stage 1 Stage 2 Decision Surveillance 1 Surveillance 2 Surveillance 3 Surveillance 4
MDR Quality Management Audit
MDR Technical MDR Technical Documentation

Documentation
Continued assessment for sampled Class Is/Im/Ir, IIa and selected IIb
Assessment
(Including Clinical)
1. Assessment of Clinical
evaluation (all case)
Min. 1 sample per product
group IIb and below
2. EU expert panel review
No sampling permitted for process (class III, class Iib
Class III and selected IIb
Active device administrate 1. Unannounced Audit (UA)
MDR Technical Documentation Assessment
drug etc 2. MDR TF/QMS Special audit (SA)

3. MDR TF/QMS Scope extension (SE)
MDR Application MDR Certification
Form Process
40 DNV GL ©
MDR 타임라인


해외인증 과정
-유럽
MDR Postponement
PANDEMIC of COVID-19 (2020.04.19 현재)
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MDD Extension issue
43 DNV GL ©
MDD Extension issue
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MDD Extension issue
45 DNV GL ©
해외인증 과정
-유럽
MDR Postponement
MDR 시행시기 연기 결정 (2020.04.19 현재)
https://www.medtechdive.com/news/proposed-eu-mdr-delay-clears-parliament-
enters-final-stages-coronavirus/576162/
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MDR Force application
MAY 2020
26th 27th
MDD
MDR
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Timelines - MDR
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해외인증 과정
-유럽
MDR Postponement
MDR 시행시기 연기 결정 (2020.04.19 현재)
MAY 2020
MDR 원문26
th
MDD
MDR
MAY 2021
MDR 개정 26th
MDD
MDR
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MDR Migration Timelines
End of Validity ALL MDD

Date of Application of MDR
Certificates
5/26/2020
5/27/2024
End of Notification MDD
5/26/2020 End of CE (MDD)
Devices (available
on the market)
Publication 2017/745 End of Validity: Annex IV Certificate
5/5/2017 5/26/2022 5/27/2025
2017 2017 2018 2019 2020 2021 2022 2023 2024 2025 2025
Today
Transition Period 5/25/2017 - 5/26/2021
MDD Cert Issuance 5/26/2017 - 5/26/2021
No Changes to
MDD devices or 5/26/2020 - 5/27/2024
Systems
MDD Devices
may be placed on 5/25/2017 - 5/27/2025
the EU Market
Period MDD Devices

can continue to be 5/26/2014 - 5/26/2025
put in to service
MDR Postponement
Until 26th Jun 2021
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MDR POSTPONEMENT
This is
tumultuous period
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EU/MDR 체계


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53
EU MEDICAL DEVICE SYSTEM

under MDR
Regulation system Regulatory BODY

the European
(EU) 2017/745 Commission
(93/42/EEC MDD)
MDCG Guidance
National Competent
documents Delegating Acts
Authorities (NCA)
(MEDDEV Guidance)
EN Harmonized standards
Implementing Acts MDR Notified body
Common specification
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54
Commission’s routine monitoring under MDR
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55
MDR 주요 변경사항


New MDR (Medical Device Regulation)
The new regulation is published !!
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New MDR – Expected Key Changes
Expected Key changes in MDR
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2018-10-02
MDR and the
Framework
Why Change -Commission “list of major changes”
▪ stricter approval requirement for high-risk devices
▪ reinforcement of the criteria for designation and processes for
oversight of Notified Bodies
▪ inclusion of certain aesthetic devices
▪ improved transparency
▪ introduction of an “implant card”
▪ reinforcement of the rules on clinical evidence
▪ strengthening of post-market surveillance
▪ improved coordination mechanisms between EU countries in the
fields of vigilance and market surveillance
DNV GL ©
This course represents internal DNV GL
Presafe copyrighted material.
It shall not be downloaded, given access

to or distributed further without prior
written consent from DNV GL Presafe.
Please respect this!
DNV GL ©
MDR key requirements


Medical device
▪ 123 Article
▪ Chapter I,II ( Article 1~24)
– Article 9 Common specifications

– Article 10 General obligation of manufacturers
– Article 12 Change of EUR
– Article 17 Single use device and their reprocessing
– Article 18 implant card
– Art. 22 System and procedure packs
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Medical device
▪ Chapter III ( Article 25~34)
– Article 25 Identification within the supply chain

– Article 27 UDI system
– Article 29 Registration of devices
– Article 30 Registration of manufacturers, EUR and importers
– Article 32 Summary of safety and clinical performance
▪ Chapter IV
– Notified body requirement
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Medical device
▪ Chapter V
– Article 51 classification
– Article 52 conformity assessment
– Article 54 clinical evaluation consultation procedure /class III, Iib
– Article 60 certificate of free sale
▪ Chapter VI
– Article 61 clinical evaluation
▪ Chapter VII
– Article 83 ~85 PMS
– Article 86 PSUR , Periodic safety update report
– Article 87 vigilance
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Medical device
▪ 17 Annexes
– I GSPR(General safety and performance requirement)
– II Technical documentation
– III Technical documentation on PMS
– VIII classification rule
– IX conformity assessment based on a QMS and assessment of the technical
documentation
– XIV clinical evaluation and PMCF
– XV Clinical investigation
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MDR Medical device code


MD CODE
2017/745/MDR
93/42/EEC MDD
MDA CODE (MEDICAL DEVICE ACTIVE CODE)
MD CODE (MEDICAL DEVICE CODE) MDN CODE (MEDICAL DEVICE NON-ACTIVE CODE)
MDS CODE (MEDICAL DEVICE SPECIFIC CODE) MDT CODE (MEDICAL DEVICE TECHNOLOGY CODE)
MDS CODE (MEDICAL DEVICE SPECIFIC CODE)
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MD CODE
93/42/EEC MDD
MD CODE (MEDICAL DEVICE CODE)

MDS CODE (MEDICAL DEVICE HORIZONTAL CODE)
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MD CODE
2017/745/MDR
MDA CODE (MEDICAL DEVICE ACTIVE CODE)

MDN CODE (MEDICAL DEVICE NON-ACTIVE CODE)
MDT CODE (MEDICAL DEVICE TECHNOLOGY CODE)
MDS CODE (MEDICAL DEVICE SPECIFIC CODE)
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MDA CODE
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MDA CODE
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MDA CODE
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MDN CODE
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MDN CODE
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MDS CODE
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MDT CODE
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MDR Conformity assessment route
적합성 평가 절차


Conformity Assessment Annexes
MDR Title MDD

Annex IX Conformity assessment based on a quality Annex II
management system and on assessment of
technical documentation
Annex X Conformity assessment based on type Annex III

examination
Annex XI Conformity assessment based on Product

Conformity Verification
-Part A Production Quality Assurance Annex V
-Part B Product Verification Annex IV
Annex XIII Procedure for Custom-made Devices Annex VIII
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Class III devices – conformity assessment procedures
Annex
IX
Class
III
Annex X
+ Annex
XI
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Class IIb devices – conformity assessment procedures
Annex IX (Chapter I+III)

and Chapter II.4 one
representative sample per
Class generic device group
IIb
Annex X
+ Annex generic device group - a set of
XI devices having the same or similar
intended purposes or a commonality of
technology allowing them to be classified
in a generic manner not reflecting
specific characteristics
Annex IX (Chapter I+III) and

Chapter II.4 for every device
* Except sutures, staples, dental fillings,

Class IIb dental braces, tooth crowns, screws,
implantable*
wedges, plates, wires, pins, clips and
Annex X + connectors
Annex XI
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Class IIa devices – conformity assessment procedures
Annex IX (Chapter I+III)

and Chapter II.4 one
representative sample for
each category of
Class devices
IIa Technical documents
(Annex II, III) +
Annex XI sec 10 or
18
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Class I devices – conformity assessment procedures
Annex II, III + EU

Class I Declaration of Conformity
(Art 19)
Annex IX (Chapter I+III)* Notified body involved only in aspects relating:

Class Is - to establishing, securing and maintaining sterile conditions
Is, Im,
Im - to confirming metrological requirements
Ir
Annex XI Part
A* Ir - to the reuse of the device, in particular cleaning, disinfection,
sterilization, maintenance and functional testing and the related
instructions for use.
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Customized device in MDR


Article 2 - Definition of Custom-made devices
제품과 관련된 사람의 전문 자격으로서 국가법에 의해 승인된 사람의 서면 처방에 따라 특별히 제작된 것으로,
제품과 관련된 사람의 책임 하에 특정 설계 특징을 제공하고 오직 특정 환자의 개별 조건 및 요구를 충족하기 위해
해당되는 환자의 전적인 사용을 위해 의도된 모든 기기를 의미한다.
그러나 전문 사용자의 특정 요건을 충족하기 위해 조정되어야 하는 대량생산기기와 허가된 사람의 서면 처방에 따라

산업 제조 과정에 의해 대량 생산되는 기기는 주문 제작기기로 간주되어서는 안 된다.
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Article 52 – Conformity assessment procedure of Custom-made Device
Annex XIII statement +

Annex IX.I Custom
Custom -made
-made Class Annex XIII statement
Class
III IIb, IIa
Annex XIII + Annex XI.A
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UDI


UDI IN EU
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EUDAMED (EUropean DAtabank on MEdical Devices)


SETUP EUDAMED
▪ https://ec.europa.eu/health/md_eudamed/actors_registration_en
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Common Specification (CS)’s Implementing act(regulation)


Single-use medical devices - safety and performance requirements for
reprocessing
▪ https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11888-Common-Specifications-for-the-reprocessing-of-single-use-medical-devices
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Single-use medical devices - safety and performance requirements for
reprocessing
▪ https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11888-Common-Specifications-for-the-reprocessing-of-single-use-medical-devices
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MDR Person responsible for regulatory compliance (PRRC)


Art. 15, Person responsible for regulatory compliance
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MDR Classification


To Be Monitored
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Outline
▪ Duration of use
– Transient use-less than 60 minute
– Short term use- between 60 minute and 30 days
– Long term use- more than 30 days
▪ Body orifice vs Surgical invasive

▪ Reusable surgical instrument
▪ Central circulatory system
▪ Central nervous system- brain,meninges and spinal cord
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Classification
Class Risk
III High
IIb Meidum-high
IIa Low-medium
I Low
Is Low
Im Low
Ir Low
Reusable surgical instrument - an instrument intended for surgical use in

cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping
or similar procedures, without a connection to an active device and which is
intended by the manufacturer to be reused after appropriate procedures
such as cleaning, disinfection and sterilisation have been carried out
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Procedural aspects
▪ Classification dispute:
– Reference to Competent Authority of Member State where manufacturer or its authorised
representative have place of buisiness
– Consultation with Competent Authorities of Notified Body’s Member State (when different)
– Inform MDCG and the Commission on its decision
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Classification Rules
Group Rules
MDD MDR
Non-invasive Devices 1-4 1-4
Invasive Devices 5-8 5-8
Active Devices 9-12 9-13
Special Rules 13-18 14-22
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MDR GSPR (Annex I)


GSPR 1-9
▪ The requirements for risk management is now in the regulation

▪ Risk mitigation methods include information for safety and training
▪ Evaluate use, storage and transport environment and base simulations on this
▪ Annex XVI devices – Risk versus benefit – but there is no medical benefit,
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GSPR 10-13 Non-Active
▪ More detailed requirements regarding chemical, physical and

biological properties
▪ Toxicological aspects of substances with specific concern are more
precise
▪ Requirements to non-sterile but clean devices are formulated
▪ Requirements to reusable devices are included
▪ New requirements to absorbable and dispersable devices
▪ Human origin tissues and cells, not only blood
▪ Non-human, non-animal biological substances requirements
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GSPR 14-19 (Active)
▪ requirements have been made

– more specific and up to general praxis
– More demanding
▪ IT security, Information security
▪ Use of handheld devices (display etc)
▪ Directive 2013/59/Euratom (Ionizing radiation)
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GSPR 20-22
▪ mechanical and thermal risks

▪ supplying energy or substances
▪ Specific requirements to protect against fitting or refitting parts and labelling
requirements for moving parts
▪ Lay user requirements
– Usability engineering need to be revisited
– Perhaps design requirements
– Manual
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GSPR 23
▪ General
– More and more explicit requirements for the IFU &
Labelling
– More information on risk, user, indication, limitation,
device
– Still no acceptance of electronic IFU
▪ Labelling shall be updated
▪ IFU/Manual shall be updated
▪ Homepage needs to have documentation(IFU etc) -
language
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MDR Declaration of conformity


Declaration of Conformity (Article 19, Annex IV)
▪ State that the requirements of MDR

and other Union legislation (when
applicable) are fullfiled
▪ By drawing declaration,
manufacturer assumes
responsibility for compliance with
the requirements of Union
legislation
▪ Manufacturer shall keep declaration
continuously updated
▪ Shall be available in an official
Union language and local language
if required by Member State
▪ Minimum content is provided in
Annex IV
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2017/745 EU MDR
QMS
2017/746 EU MDR QMS
MDR Lead Auditor
2021-03-18
MDR QMS Establishment by Manufacturer
MDR QMS in Article 10
ISO13485 MEDICAL DEVICE
QUALITY MANAGMENET SYSTEM
=
114 DNV ©
MDR QMS Audit by Notified Body
MDR QMS in Article 10
ISO13485 MEDICAL DEVICE
QUALITY MANAGMENET SYSTEM
=
NB’s ISO13485 AND MDR QMS Audit plan/process could be conducted horizontally.
However, Audit report should be separately documented under ISO13485 or MDR QMS
115 DNV ©
4.X Quality System Requirements

MDR Lead Auditor
Soo.hyuk.uhm@dnv.com
www.dnv.com
116 DNV ©
CH 4. Quality System requirements
1. Procedure and/or template for generation and issue of declaration of conformity
2. Authorized representative
3. if relevant, instructions for use in website
4. Fulfill language requirements and Translation procedure
5. Single Registration Number
6. Procedure related to UDI
7. Retention time of minimum 10 years (15 Years for Implants)/ TF etc
8. System to ensure that changes in harmonized standards, or CS
9. Procedure for reporting planned changes to the system and/or devices notified body
10.Implantable devices and Class III devices - summary of safety and clinical performance
11. Systems and procedure packs procedure-NB involvement in case
117 DNV ©
CH 4. Quality System requirements
12. Evaluation of the need for reporting the change to the Notified body
13. obsoleted certificates (replaced by a new version) issued by Notified body is withdrawn from us
e
14. list of devices covered by the Presafe certificates
15.Technical documentation shall be established, maintained and follow annex II and III
16.available within a reasonable timeframe - list of devices: immediately, Technical file – only time
allowed to compile the documents – thus within 1-2 days
118 DNV ©
5.X Management

MDR Lead Auditor
www.dnv.com
119 DNV ©
CH 5. Management
1. Identification of person(s) with authority to sign the declaration of conformity

2. Appointment PRRC(people responsible regulatory compliance)
3. Methods of monitoring/The data should include data on Incidents, recalls, audits and be part of
management review
4. Quality policy and/or Quality management system
120 DNV ©
6.X Resource management

MDR Lead Auditor
www.dnv.com
121 DNV ©
CH 6. Resource
1. Person(s) responsible for regulatory compliance shall fulfill the educational and experience requ
irements
2. Competence requirement for
• persons being involved in Clinical Investigation,
• Persons involved in clinical evaluation, PMS plans and systems, PSUR,
• persons involved in risk management,
• QA and RA personnel,
• Internal auditors
122 DNV ©
7.X Product realization

MDR Lead Auditor
www.dnv.com
123 DNV ©
CH 7. Product realization
1. Risk management system
2. Customer related process/ Sales & Marketing.

• Traceability
• Reporting complaints, post market feedback, incidents etc. to the manufacturer – including time frames
• Participation in FSCA
• Keeping registers for complaints etc.
• The manufacturer does not use quality management system or device approvals in a misleading manner /
Misbranding in relation to customer communication.
124 DNV ©
CH 7.3 Design process
1. Procedure for “Strategy for regulatory compliance
2. Procedure ensuring identification of applicable general safety and performance requirements
3. Technical documentation shall be established, maintained
4. general safety and performance requirements – Verification/validation report reference
5. Procedure and system for the clinical evaluation
6. Procedure and system post-market clinical follow-up (PMCF )
7. Procedures for clinical evaluation /PMCF
8. Procedures and techniques for pre-clinical evaluations
9. Procedure for fulfilling the requirements for information to be supplied with the device
10.Implant card-“understood by lay person” thus usability
11.design change process -Evaluation of impact of MDR compliance/reporting to NB
125 DNV ©
CH 7.4 Purchasing
1. the methods of monitoring of outsourced process
2. Contract between the manufacturer and crucial suppliers/critical subcontractors /*** notified bod
y shall evaluate the Need for audit critical supplier and subcontractors
3. Verification/ risk analysis and the GSPR
126 DNV ©
CH 7.5 Production
1. sterilization and the relevant document
2. Procedure for the appropriate tests
3. Verification that the processes and the validations/verifications are as described in Technical do
cumentation including (but not limited to) the risk analysis and the GSPR
4. In the case of class III devices, the surveillance assessment shall also include a test of the appr
oved parts and/or materials that are essential for the integrity of the device
127 DNV ©
8.X Measurement, analysis and
improvement

MDR Lead Auditor
www.dnv.com
128 DNV ©
CH 8 Measurement, analysis and improvement
1. Post-market surveillance System and plans
2. Procedure shall be established for Periodical safety update reports (PSUR )
3. Procedures for vigilance shall be established including
4. Procedure and system post-market clinical follow-up (PMCF)
129 DNV ©
Please contact DNV offi
ce
• DNV will help you to estimate when should
you apply:
• Free
• Based on:
** Type of your products
** Quantity of your products
** Your existing situation
130 DNV ©
THANK YOU
soo.hyuk.uhm@dnv.com
MDR Lead Auditor

20210610 - 1차 의료기기 해외GMP 인증과정 교육 - 엄수혁 - 배포용

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MDR 규제요구사항과

MDR 의료기기 품질경영시스템

• 연세대학교 치과대학 박사후 과정 연수 (2년 연수)

엄 수 혁, 치의학박사 [심사 자격]

• 2017/745 MDR Senior Technical Document Assessor (~2b등급 기술문서심사원)

• 2017/745 MDR Senior Clinical Document Assessor (임상자료 기술문서심사원)

156 12,000 100,000 100+ 5% R&D

Ship and offshore Energy advisory, Software and Management system

To safeguard life, A trusted voice

Digital Assurance Energy Maritime

Ocean Space Health Care Future Assurance Business

Industry Technology Ocean Energy Transition

2021 2030 2050 2050

A trusted voice to tackle gl

Future Designation Plans:

SOO HYUK UHM, Ph.D., in Dentistry

18 DNV GL © SAFER, SMARTER, GREENER

SOO HYUK UHM, Ph.D., in Dentistry

20 DNV GL © SAFER, SMARTER, GREENER

EU MEDICAL DEVICE SYSTEM

Regulation system Regulatory BODY

SOO HYUK UHM, Ph.D., in Dentistry

23 DNV GL © SAFER, SMARTER, GREENER

SOO HYUK UHM, Ph.D., in Dentistry

32 DNV GL © SAFER, SMARTER, GREENER

SOO HYUK UHM, Ph.D., in Dentistry

37 DNV GL © SAFER, SMARTER, GREENER

MDR Unannounced Audits

MDR Quality Management Audit

MDR Technical MDR Technical Documentation

Min. 1 sample per product

No sampling permitted for

MDR Application MDR Certification

BY TF ASSESSMENT TEAM : Assessor, Trainee-Assessor, Clinical Assessor

MDR Audit Stage 1 TF ASSESSMENT

BY QMS AUDIT TEAM : LEAD AUDITOR/AUDITOR/TRAINEE-AUDITOR/TRAINEE-LEAD AUDITOR

MDR Unannounced Audits

MDR Quality Management Audit

MDR Technical MDR Technical Documentation

drug etc 2. MDR TF/QMS Special audit (SA)

SOO HYUK UHM, Ph.D., in Dentistry

41 DNV GL © SAFER, SMARTER, GREENER

PANDEMIC of COVID-19 (2020.04.19 현재)

End of Validity ALL MDD

MDD Cert Issuance 5/26/2017 - 5/26/2021

Period MDD Devices

SOO HYUK UHM, Ph.D., in Dentistry

52 DNV GL © SAFER, SMARTER, GREENER

EU MEDICAL DEVICE SYSTEM

Regulation system Regulatory BODY

SOO HYUK UHM, Ph.D., in Dentistry

56 DNV GL © SAFER, SMARTER, GREENER

The new regulation is published !!

Expected Key changes in MDR

It shall not be downloaded, given access

Please respect this!

SOO HYUK UHM, Ph.D., in Dentistry

61 DNV GL © SAFER, SMARTER, GREENER

▪ Chapter I,II ( Article 1~24)

– Article 9 Common specifications

▪ Chapter III ( Article 25~34)

– Article 25 Identification within the supply chain

SOO HYUK UHM, Ph.D., in Dentistry