Medical Regulatory AdvisoryServices 유럽의료기기법규 CE...

$: Medical Regulatory AdvisoryServices 유럽의료기기법규 CE …manage.kimsonline.co.kr/UFolder/GovNews/식약처\공지\(2013-11... · Overview • RegulatoryFramework •Classification$
Medical Regulatory Advisory ServicesAdvisory Services 유럽 의료기기 법규

CE-Markingh i l il iTechnical File Requirements

Paul Malinovski

UL LLC © 2012 All Rights Reserved

Overview

• Regulatory Framework 규정 프레임워크Regulatory Framework 규정 프레임워크

• Classification of medical devices 의료기기 분류

• Risk Management EN ISO 14971 위험 관리

• Biological Evaluation EN ISO 10993-1 생물학적 평가

• Clinical Evaluation MEDDEV 2.7.1 임상 평가

h i l i / i i 기술문서/설계문서• Technical Documentation / Design Dossier 기술문서/설계문서

• QM EN ISO 9001 / EN ISO 13485 품질관리시스템

UL LLC © 2012 All Rights Reserved2

Overview

• Regulatory FrameworkRegulatory Framework

• Classification of medical devices

• Risk Management EN ISO 14971

• Biological Evaluation EN ISO 10993-1g

• Clinical Evaluation MEDDEV 2.7.1

• Technical Documentation / Design Dossier

• QM EN ISO 9001 / EN ISO 13485/


Regulatory Framework 규정 프레임워크

Directives:

- MDD 93/42/EEC for medical devices(의료기기)

- AIMDD 90/385/EEC for active implantable medical devices(능동 삽입 의료기기)

- IVDD 98/79/EC for in-vitro diagnostic(체외 진단)

For CE mark devices might also have to fulfil the requirements of Machinery Directive and Personal Equipment Directive.

CE 마크를 위해서 해당되는 경우 Machinery Directive and Personal Equipment Directive의요구사항을 충족해야 한다.

As of July 2014: RoHs Directive 2011/65/EU (Restriction of the use of certain hazardous substances in electrical and electronic equipment)

2014년 7월 22일부터 의료기기에 RoHs Directive가 강제 적용됨.

4

Overview







• QM EN ISO 9001 / EN ISO 13485/


Classification of medical devices 의료기기 분류

Classification according to the rules in Annex IX, MDD

MDD Annex IX 규칙에 따른 의료기기 분류MDD Annex IX 규칙에 따른 의료기기 분류

Risk classes:

I I I• I, Is, Im

• IIa

• IIb

III• III

Class I devices do not require the involvement of the Notified Body, however for Isd I !and Im!

Netherless, the requirements are the same!

Class I 의료기기는 Notified Body 의 심사를 필요로 하지 않는다. 하지만 Is 와 Im 의기기는 필요하다기기는 필요하다.

Notified Body 의 심사를 필요로 하지 않는다 하더라도, 의료기기로써 필요한 모든요구사항들은 준수하여야 한다.

6UL LLC © 2012 All Rights Reserved

Conformity Assessment Procedures 심사 절차


Classification of medical devices 의료기기 분류

Distribution of medical devices risk classes reported to

DIMDI (German Insitute of Medical Documentation and Information)DIMDI (German Insitute of Medical Documentation and Information)

의료기기 분류에 따른 구성 비율(독일의료정보협회)


Overview

• Regulatory Frameworkg y






• QM EN ISO 9001 / EN ISO 13485


Risk Management 위험 관리

What is the meaning of „Risk Analysis“? 위험 분석의 의미?

• Initial risk analysis of potential risks associated with the investigational deviceInitial risk analysis of potential risks associated with the investigational device according to the harmonised standard 조화 규격을 참조하여 해당 제품에 대하여잠재적 위험에 대한 초기 위험 분석

• EN ISO 14971:2012 (The Annex ZA, ZB, or ZC are updated!), , p

• During the Entire Product Life-Cycle:

From project start 프로젝트 시작 부터

During design and development phase 설계 및 계발 단계 동안

During manufacturing phase 제조 단계 동안

During market phase 제품 판매 단계 동안

Until market removal resp. disposal 제품의 회수 및 폐기 까지

Risk management is a continuous & repetitive process!

위험 관리는 지속적이며 반복적인 프로세스이다.

10


Risk Management according to the ISO 14971

ISO 14971에 따른 위험 관리

In order to achieve and keep a positive risks versus benefits ratio, any medical device manufacturer must:

위험관리를 성공적으로 하기 위해서 의료기기 제조자는 다음 사항을 준수해야 한다위험관리를 성공적으로 하기 위해서 의료기기 제조자는 다음 사항을 준수해야 한다.

1. Ensure that a device achieves the intended performances 의료기기의 사용목적 및성능을 명확히 할 것

2. Eliminate or reduce risks as far as possible 가능한 수준까지 위험을 제거하거나 줄일것

3. Apply preventive measures, if certain risks cannot be eliminated 위험을 제거할 수없는 경우 방어 수단을 적용할 것없는 경우 방어 수단을 적용할 것

4. Ensure that any undesirable side-effect constitutes an acceptable risk when weighed against the intended performances and patients‘ benefits 다른 의도하지않은 수용 가능한 부작용이 있는지 명확히 할 것않은 수용 가능한 부작용이 있는지 명확히 할 것

5. Inform users of the residual risks 사용자에게 잔여 위험을 알릴 것

11


Initiate the risk management process 위험 관리 프로세스 시작

1. Study the current version of ISO 14971 (Updated 2012!) ISO 14971 개정판에 대한이해

2. Prepare a risk management plan 위험 관리 계획 준비

3. Prepare a risk management table to 위험 관리 테이블 준비- document the risk analysis process (e.g. FMEA) 위험 분석 프로세스 문서화- summarize any corrective and preventive action (CAPA) 시정 및 예방 조치 요약

4 Ri k i i h l 위험 관리 회의4. Risk management meeting with at least: 위험 관리 회의- Management representative, Manufacturing responsible persons, Marketing /

Sales, QM representative 최고경영자, 제조 관련 직원, 마케팅/세일즈 직원, 품질관리책임자책임자

5. Risk management report 위험 관리 보고서

12


What is the meaning of „Risk Analysis“? 위험 분석의 의미

• Initial risk analysis of potential risks associated with the investigational device according to the harmonised standard EN ISO 14971:2012 EN ISO 14971:2012 조화 규격을 참조하여 해당 제품에 대하여잠재적 위험에 대한 초기 위험 분석

• Followed by a continuous risk management process to identify potential risks• Followed by a continuous risk management process to identify potential risks associated with the medical device and to decide if a clinical investigation is necessary-> Input for the Clinical Evaluation 임상 조사가 필요한지 판단하고 의료기기와 관련된잠재적인 위험이 있는지 확인하기 위해 지속적으로 위험 관리 프로세스를 따름

• Information obtained from the Clinical Evaluation process is fed into the ongoing Risk A l i 임상 평가 프로세스를 통해 획득된 정보는 위험 분석에 사용됨Analysis 임상 평가 프로세스를 통해 획득된 정보는 위험 분석에 사용됨

13

Risk Management Process 위험 관리 프로세스

14

Risk Management Process 위험 관리 프로세스

15

Risk Management – Reported Risks to BfArm

Incidents reported to the BfArm (Federal Institute for Drugs and Medical Devices)

16

Risk Management – Reported Risks to BfArm

17

Overview

• Regulatory Framework


• Risk Management EN ISO 14971Risk Management EN ISO 14971

• Biological Evaluation EN ISO 10993-1

• Clinical Evaluation MEDDEV 2 7 1• Clinical Evaluation MEDDEV 2.7.1


• QM EN ISO 9001 / EN ISO 13485

• Team in Ochsenhausen, Services / experience


Biological Evaluation 생물학적 평가

„Declaration of Compliance“ according to EN ISO 10993-1

EN ISO 10993-1에 따른 적합성 선언

Documented Evidence of the Biocompatibility 생물학적 적합성을 위한 문서화된 증거

• Summarizes any pre-clinical study results from accredited laboratories 승인된y p y시험기관에서 실시한 전임상 시험에 대한 요약

• Scientific justification for not performing certain tests 시험 예외 항목에 대한 과학적인정당성

• Scientific literature or toxicological data search 과학적인 문헌 또는 독성 데이터 조사

Requirement for Preparation: 준비 요구사항

• Intended purpose, type and duration of body contact 사용목적, 인체 접촉 유형 및기간

• All available test reports 모든 가능한 시험 보고서

• Typically a previous test strategy required! 테스트 전략 요구됨

19

Overview







• QM EN ISO 9001 / EN ISO 13485/


Clinical Evaluation 임상 평가

European Strategy: Clinical Evaluation Process

Define Device & Intended Use

Go Through Risk No clinical Provide JustificationGo Through Risk Management Process

No clinical data required

Provide Justification in Technical File

Perform Clinical Evaluation Using

Sufficient Literature for Substantially

Clinical Investigation of the Investigational

Combination of Literature and Clinical or orEquivalent Devices

(Annex X 1.1.1)Device Required(Annex X 1.1.2)

Investigation Data(Annex X 1.1.3)

or or

Clinical Evaluation Report Justifying Clinical Performance & Safety



Risk

European Strategy: Clinical Evaluation Process

Clinical MEDDEV

LiteratureReview

(MEDDEV 2 7 1)

RiskManagement

EN ISO 14971

Evaluation 2.7.1(MEDDEV 2.7.1)

Post Market

-

Clinical

Surveillance (MEDDEV 2.12-1)

PMCFStudies

(MEDDEV 2.12/2)

Clinical Investigation (ISO 14155)



MEDDEV 2.7.1: Definition of "Clinical Data" 임상 데이터의 정의

Safety and/or performance information that are generated from the use of a medical„Safety and/or performance information that are generated from the use of a medical device 의료기기의 사용으로 부터 생성된 안전성 및 성능에 관한 정보(this term is further explained in GHTF document SG5/N1R8:2007)“

• Results from clinical investigations with the investigational device 해당 제품의 임상조사의 결과

• Results from clinical studies with CE-marked devices CE 승인 제품의 임상 시험의결과

• Published data from clinical studies or other clinical results with comparable medical devices 임상 시험을 통해 발표된 데이터 또는 다른 유사 제품의 임상 결과NOTE: Comparability must be duly justified! 유사성은 입증되어야 함

• Post market surveillance data with the device in question or with comparable devices 사후 조사를 통해 획득된 정보

NOTE: Further definitions see GHTF Document SG5/N1R8 추가 정의에 대한 정보는 GHTF 문서 SG5/N1R8 참조

23

Clinical Evaluation - Definitions 임상 평가 – 정의

• Clinical Study: 임상 시험A study with a CE marked medical device. Typically a PMCF (Post Market Clinical Follow Up Study)according to the MEDDEV 2.12-1.

• Clinical Investigation: 임상 조사The new device or device with new indication has no CE mark, Therefore, a study for the CE certification according to EN ISO 14155.

• Clinical Evaluation: 임상 평가Documented and evaluated results from own clinical data and/or Literature Review according to the MEDDEV 2.7.1.

24

Overview

• Regulatory Framework


• Risk Management EN ISO 14971Risk Management EN ISO 14971

• Biological Evaluation EN ISO 10993-1

• Clinical Evaluation MEDDEV 2 7 1• Clinical Evaluation MEDDEV 2.7.1


• QM EN ISO 9001 / EN ISO 13485

• Team in Ochsenhausen, Services / experience


Technical Documentation 기술 문서

Every medical device needs a complete technical file that demonstrates the “state of art” and the “high level of safety and performance”.

모든 의료기기는 해당 의료기기의 기술수준과 의료기기의 안전성 및 성능 등을 입증하는모든 의료기기는 해당 의료기기의 기술수준과 의료기기의 안전성 및 성능 등을 입증하는기술문서를 필요로 한다.

All medical devices must fulfill the “Essential Requirements” set out in the Annex IAll medical devices must fulfill the Essential Requirements set out in the Annex I, MDD.

모든 의료기기는 MDD, Annex I 에 정의된 “필수 요구사항”을 만족해야 한다.

For STED: “Essential Principles” GHTF/SG1/N68:2012

Relevant standards may be used to demonstrate the compliance with the essentialRelevant standards may be used to demonstrate the compliance with the essential requirements.

관련된 규격들이 필수 요구사항의 만족을 입증하기 위해 사용될 수 있다.

26

Which standards are available / applicable?Significance of Harmonized Standards 조화 규격의 의미Significance of Harmonized Standards 조화 규격의 의미

MDD Article 5.1 states:

Member states shall presume compliance with the essential requirements„Member states shall presume compliance with the essential requirementsreferred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the reference of which have been published in the Official Journal of the European p pUnion“

A standard is considered “harmonized” after it has been referenced in the “Offi i l J l f h C i i ” 조화 규격은 유럽 관보에서“Official Journal of the European Communities” 조화 규격은 유럽 관보에서찾아볼 수 있다.

If h i d t d d h b li d th tifi d b d illIf harmonized standards have been applied, the notified body will assume compliance with the respective essential requirements (“Conformity Assumption”) 조화 규격이 적용된 경우, NB는 각각의 필수요구사항을 만족하는 것으로 간주한다.구사항을 족하 것 주 다

27

Technical Documentation / Design Dossiers (Cl III)(Class III)•Two main parts: 2가지 주요 부분

Part A with 6 main chaptersPart A with 6 main chaptersPart B with 17 main chapters

• Comply with all relevant legal requirements: 관련된 법적 요구사항• Comply with all relevant legal requirements: 관련된 법적 요구사항

MDD 93/42/EEC

NB-MED/2.5.1/Rec5

STED: GHTF/SG1/NO11:2012Essential Principles: GHTF/SG1/N68:2012Classification: GHTF/SG1/N77:2012

• Usually written bilingual (English and local language) 보통 자국어와 영어로 작성됨

28

Summary Technical Documentation (STED)

according to the GHTF/SG1/N011:2008

Device Description 제품 설명• Device Description 제품 설명

• Product Specification, previous generation / similar products 제품 사양

• Essential Principles: EP-Checklist in GHTF/SG1/N68:2012, 필수 원칙

Ri k l i d t l 위험 분석• Risk analysis and control summary 위험 분석

• Product Verification and Validation incl. sterilisation, biocompatibility, biological safety, software, clinical evidence. 제품 검증

29

Summary Technical Documentation (STED)( )(cont.)Essential Principles of Safety and Performance according to the GHTF SG1/NO63:2011according to the GHTF SG1/NO63:2011

안전성 및 성능에 대한 필수 원칙

• Design and Manufacturing Information 설계 및 제조 정보• Design and Manufacturing Information 설계 및 제조 정보

• Labelling 라벨링

• Declaration of Conformity if available 적합성 선언, 해당되는 경우

GHTF/SG1/NO11:2008:Summary Technical Documentation for Demonstrating ConformityGHTF/SG1/NO11 2008 Summary Technical Documentation for Demonstrating Conformityto the Essential Principles of Safety and Performance of Medical Devices (STED)

30

Summary Technical Documentation (STED)Cl ifi iClassification

based on rules derived from the potential of a medical device to cause harm to abased on rules derived from the potential of a medical device to cause harm to a

patient or user and on its intended use / technology:

CLASS LEVEL Examples

A Low Hazard Bandages / tongue depressors

B Low-Moderate Hazard Hypodermic Needles / suction equipment

C Moderate-high Hazard Lung ventilator / bone fixation plate

D High Hazard Heart valves / implantable defibrillator

GHTF/SG1/N77:2012: Principles of Medical Devices Classification

31

Technical DocumentationP k t U f STED (GHTF/SG1/N011:2008)Premarket Use of STED (GHTF/SG1/N011:2008)

32

Technical DocumentationP t M k t U f STED (GHTF/SG1/N011:2008)Post-Market Use of STED (GHTF/SG1/N011:2008)

33

Overview







• QM EN ISO 9001 / EN ISO 13485/


Quality Management 품질 관리

Support for a new or existing Quality Management System according to ISO 13485

ISO 13485에 따른 품질 관리 시스템ISO 13485에 따른 품질 관리 시스템

• Set up a quality management manual 품질 관리 매뉴얼 수립

P ti f ll li bl SOP 모든 적용 가능한 절차서 준비• Preparation of all applicable SOPs 모든 적용 가능한 절차서 준비

• Amend existing documents and SOPs 수정된 현재 문서 및 절차서

• Support during audits 심사 기간 중 지원

If any management system exists: Pre-check of documents and preparation of an activity list

만약 다른 품질 시스템이 존재하는 경우: 활동 리스트에 대한 문서 및 준비 사전 확인

Each manufacturer of medical devices has to establish a quality management system in accordance with EN ISO 13485!

각 의료기기 제조자는 EN ISO 13485에 따라 품질 관리 시스템을 수립해야 한다.

35

Quality Management 품질 관리

36

Quality MManagement품질 관리

37

Medical Regulatory AdvisoryServices 유럽의료기기법규 CE...

Documents

Transcript of Medical Regulatory AdvisoryServices 유럽의료기기법규 CE...