Medical Device
Regulation
The Fastest Route to Europe:
Your Express Journey Begins Here!
TÜV NORD Korea | Medcal Device Regulation | 2024
TÜ V NORD at glance
Figures, data, facts*
150 30 2
1,451.8 Years
Years history for Notified bodies MDR
Million Euros in sales History proves our value Medical device industry We are Team NB
86
> 14,000 100 3 Years Group affiliates
in a row Eco Vadis 44 of these abroad
Employees worldwide Active in 100 countries Sustainability Gold Seal (*All data from 04/2023)
2 TÜ V NORD Korea | Medcal Device Regulation | 2024
Fastest Route to Europe
We Have Two Paths
Fast Easy
2 Notified bodies Communication
▪ Germany, Poland. ▪ Korean project manager is here
▪ More options, less waiting to stay
▪ Same language,
▪ regardless of time zone
3 TÜ V NORD Korea | Medcal Device Regulation | 2024
Choose your future
Two NBs and Korea first
TÜV NORD : More options, less waiting Another place, you might..
4 TÜ V NORD Korea | Medcal Device Regulation | 2024
Process
From application to completion, we're with you every step of the way.
인증신청 기술문서, 제출된 문서 검토 후 기술 및 임상 품질경영시스템 TD 및 QM 인증서 발행여부 인증서 발행 및
품질매뉴얼 등의 심사일정 제안 및 문서 평가 심사 부적합 관리 결정 EUDAMED
신청서 제출 견적서, 계획 송부 • (특정 등급의 경우) database 등재
임상 협의
• SSCP (Summary 인증서 발행 이후: 시
of safety and 판 후 조사 (Post-
clinical Market Surveillance)
performance) 및 제품 업데이트 등
필요한 경우 TD 평가
및 심사 프로그램 조정
5 TÜ V NORD Korea | Medcal Device Regulation | 2024
From application to completion,
we're with you every step of the way
I am your project
MDR manager who
makes it happen
6 TÜ V NORD Korea | Medcal Device Regulation | 2024
First come, first served.
MDD→ MDR TIMELINE
등급 구분 2023 2024 2025 2026 2027 2028
• ClassⅠm, Ⅰs 기존 2024.05.26
• ClassⅡa
• ClassⅡb
변경 2028.12.31
• ClassⅡb 이식형 기기 기존 2024.05.26
• Class Ⅲ
변경 2027.12.31
제조사는 2024.05.26까지 MDR 신청서 제출이
완료되어야 MDD 연장이 가능합니다.
• 2024년 5월까지 만료 예정인 MDD 인증서 22,376 개
• MDR 인증 지정 NB는 36개
• 신청 시기가 늦춰질수록 인증 소요기간은 길어지게 됩니다.
7 TÜ V NORD Korea | Medcal Device Regulation | 2024
Wherever your product
located
TÜV NORD can go
Auditors Worldwide
Korea, China, Taiwan, Indonesia and India
Europe
USA
Asia
South
America Australia 2 NBs
More options, less waiting
8 TÜ V NORD Korea | Medcal Device Regulation | 2024
TÜ V NORD : Your gateway to the world.
MDD MDR
ISO 13485 MDSAP
9 TÜ V NORD Korea | Medcal Device Regulation | 2024
Scopes
MDA
MD Scope Scope Germany Poland
MDA 0101 Active implantable devices for stimulation / inhibition / monitoring
MDA 0102 Active implantable devices delivering drugs or other substances
MDA 0103 Active implantable devices substituting or replacing organ functions
MDA 0104 Active implantable devices utilising radiation and other active implantable devices
MDA 0201 Active non-implantable imaging devices utilising ionizing radiation O
MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation O O
MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters O O
MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis O O
MDA 0301 Active non-implantable devices utilising ionizing radiation O
MDA 0302 Active non-implantable devices utilising non-ionizing radiation O O
MDA 0303 Active non-implantable devices utilising hyperthermia / hypothermia
MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)
MDA 0305 Active non-implantable devices for stimulation or inhibition O O
MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemopheresis O O
MDA 0307 Active non-implantable respiratory devices O O
MDA 0308 Active non-implantable devices for wound and skin care O O
MDA 0309 Active non-implantable ophthalmologic devices O
MDA 0310 Active non-implantable devices for ear, nose and throat O
MDA 0311 Active non-implantable dental devices O O
MDA 0312 Other active non-implantable surgical devices O O
MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport O O
Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive techn
MDA 0314
ologies (ART)
MDA 0315 Standalone software O O
MDA 0316 Medical gas supply systems and parts thereof O O
MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation O O
MDA 0318 Other active non-implantable devices O
10 TÜ V NORD Korea | Medcal Device Regulation | 2024
Scopes
MDN
MD Scope Scope Germany Poland
MDN 1101 Non-active cardiovascular, vascular and neurovascular implants O
MDN 1102 Non-active osteo- and orthopaedic implants O O
MDN 1103 Non-active dental implants and dental materials O O
MDN 1104 Non-active soft tissue and other implants O O
MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care O
MDN 1202 Non-active non-implantable devices for administration, channeling and removal of substances, including devices for dialysis O O
MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters and related tools O
MDN 1204 Non-active non-implantable medical devices for wound and skin care O O
MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices O
MDN 1206 Non-active non-implantable ophthalmologic devices O
MDN 1207 Non-active non-implantable diagnostic devices O
MDN 1208 Non-active non-implantable instruments O O
MDN 1209 Non-active non-implantable dental materials O O
MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases O
MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing O O
Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive tech
MDN 1212 O
nologies (ART)
MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route O O
MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices O O
MDN 1101 Non-active cardiovascular, vascular and neurovascular implants O
MDN 1102 Non-active osteo- and orthopaedic implants O O
MDN 1103 Non-active dental implants and dental materials O O
MDN 1104 Non-active soft tissue and other implants O O
MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care O
MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis O O
MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters and related tools O
MDN 1204 Non-active non-implantable medical devices for wound and skin care O O
11 TÜ V NORD Korea | Medcal Device Regulation | 2024
Scopes
MDS
MD Scope Scope Germany Poland
MDS 1001 Devices incorporating medicinal substances O O
MDS 1002 Devices manufactured utilising tissues or cells of animal origin, or their derivatives
MDS 1003 Devices manufactured utilising tissues or cells of human origin, or their derivatives
MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC 1 O
MDS 1005 Devices in sterile condition: O O
Aseptic filling O O
EO O O
moist heat O O
radiation (Gamma-, Elektronen-, Röntgenstrahlen) O O
Formaldehyde incl low-temperature steam-formaldehyde sterilization O
hydrogen peroxide O
thermical sterilization processes, dry heat O
tthermical sterilization processes using liquid sterilization agents
If designation is sought for other processes, these need to be specified: Plasma O
If designation is sought for other processes, these need to be specified: Filtration O
MDS 1006 Reusable surgical instruments O O
MDS 1007 Devices incorporating or consisting of nanomaterial O O
Devices utilising biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a c
MDS 1008 O
hemical change in the body
Devices incorporating software / utilising software / controlled by software, including devices intended for controlling, monitoring or directly influencing the performance
MDS 1009 O O
of active or active implantable devices
MDS 1010 Devices with a measuring function O O
MDS 1011 Devices in systems or procedure packs O O
MDS 1012 Products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 O
MDS 1013 Class III custom-made implantable devices O
MDS 1014 Devices incorporating as an integral part an in vitro diagnostic medical device O
12 TÜ V NORD Korea | Medcal Device Regulation | 2024
Scopes
MDT
MD Scope Scope Germany Poland
MDT 2001 Metal processing O O
MDT 2002 Plastic processing O O
MDT 2003 Non-metal mineral processing including glass, ceramics O O
MDT 2004 Non-metal non-mineral processing including textiles, rubber, leather, paper O O
MDT 2005 Biotechnology O O
MDT 2006 Chemical processing O O
MDT 2007 Production of pharmaceuticals O O
MDT 2008 Clean room production O O
MDT 2009 Processing of materials of human or animal origin O
MDT 2010 Manufacture or processing of electronic components including communication devices O O
MDT 2011 Packaging, including labelling O O
MDT 2012 Installation, refurbishment O O
MDT 2013 Reprocessing of medical devices O
13 TÜ V NORD Korea | Medcal Device Regulation | 2024
FAQ
Q. 인증 소요기간이 궁금합니다.
▪ EU 집행위원회에서 공식 발표한 통계에 따르면
( 우 측 도 표 참 조 ) 통 상 적 으 로 MDR 인 증 에 는
통상적으로13~18개월이 소요됩니다.
▪ TÜV NORD Poland 와 인증을 진행하시는 경우엔
최대 12개월 이내에 인증서 취득이 가능합니다.
▪ Source : European Commission 'Notified Bodies Survey on certifications and applications
14 TÜ V NORD Korea | Medcal Device Regulation | 2024
FAQ
Q. MDD 인증을 TÜ V NORD 에서 받지 않았어도 빠르게 MDR Q. 견적서를 받는데 얼마나 걸릴까요?
인증을 받을 수 있나요?
• 제출 된 서류에 추가 보완되어야 할 사항이 없을 경우, 통상적으로 견적서 발행까진
• 기존에 TÜV NORD에서 MDD 인증을 받지 않으셨더라도 TÜV NORD에서 빠르게 3주~4주의 기간이 소요됩니다.
MDR 인증을 받으실 수 있습니다. • 견적서에 서명하신 후 3개월 내 심사를 시작할 수 있으며, 인증까지는 통상 9-12개
월 정도 소요되고 있습니다.
• 다른 NB의 경우, 기존 MDD 고객을 위주로 MDR 전환을 진행하고 있어 신규 업체
를 받지 않는 경우가 있고, 받더라도 신규 고객은 후순위로 밀리는 경우가 많아 심
사를 시작하는 데까지 1년 이상 소요되는 곳도 많을 것입니다.
• TÜV NORD의 경우 두개의 NB가 등록 되어있어 고객이 빠르게 인증을 진행할 수 Q. 기술문서와 품질 매뉴얼 모두 준비되어 있어야 하나요?
있습니다. 이런 점을 고려했을 때, TÜV NORD는 신규 고객이 심사를 가장 빠르게
시작할 수 있는 최선의 선택이 될 것입니다.
• 기술문서와 품질 매뉴얼을 모두 제출해 주셔야 application review가 진행될 수
있습니다.
15 TÜ V NORD Korea | Medcal Device Regulation | 2024
We're here to make it
easy for you.
Keren Yang
MDR Project manager
+82-10-5488-4397
kerenyang@tuv-nord.com
tuev-nord.de
