7.

The European Authorized Representative activities in view of newly published MDR

新頒布的法規MDR – 关于歐盟授權代表的工作

Free Sales Certificates 4

Post-Market Surveillance

3

Incident Reporting

2

Registration Issues in Europe 1

Agenda

7. Dezember 2017

自由銷售證明 4

產品上市後監督 3

不良事故報告 2

歐盟境內產品註冊 1

議 程

7. Dezember 2017

7. Dezember 2017

… means any natural or legal person established

within the Union who has received and accepted

a written mandate from a manufacturer, located

outside the Union, to act on the manufacturer's

behalf in relation to specified tasks with regard to

the latter's obligations under this Regulation

… means any natural or legal person established

in the Community who, explicitly designated by

the manufacturer, acts and may be addressed by

authorities and bodies in the Community instead

of the manufacturer with regard to the latter's

obligations under this Directive

MDR 2017/745 MDD 93/42/EEC

7. Dezember 2017

指歐盟中的任何自然人或法人，其收到并接受欧盟

境外制造商的书面指定，按照(MDR)法规要求，代

表制造商履行该法规规定的授權代表职责。

指歐共体中的任何自然人或法人，其由生產商明確

指定，按照(93/42/EEC)指令要求履行歐盟代表职

责，並代表制造商接受歐盟主管部門和相關機構的

接洽。

MDR 2017/745 MDD 93/42/EEC

Free Sales Certificates 4

Post-Market Surveillance

3

Incident Reporting

2

Registration Issues in Europe 1

Agenda

7. Dezember 2017

自由銷售證明 4

產品上市後監督 3

不良事故報告 2

歐盟境內產品註冊 1

議 程

7. Dezember 2017

This allows market surveillance by the competent authority

7. Dezember 2017

Authorized Representative shall inform the

competent authority of the member state in which

he has his registered place of business about

• his place of business

• the devices for that he is responsible

Why do you need to register your product in Europe ?

8

Before placing a device on the market, authorised

representatives shall submit information about

himself, the person responsible for regulatory

compliance and the devices for that he is responsible

to a central electronic system (EUDAMED). The

information must be confirmed regularly.

MDR 2017/745, Art. 29 MDD 93/42/EEC Art. 14:

從 而 使 得 主 管 當 局 能 有 效 執 行 市 場 監 管

7. Dezember 2017

授權代表必須向其辦公註冊所在當地的歐盟成員國主管當局報備： • 其辦公場所 • 其代表的醫療器材

為 什 麽 需 要 在 歐 盟 註 冊 產 品?

9

醫療器材上市前，授權代表必須向中央电子数据系统

（EUDAMED）完成授权代表的自我報備，并提交合

规责任人和其代表的产品信息。以上信息必须进行定

期确认。

MDR 2017/745 第29条 MDD 93/42/EEC 第14条

Information needed by your EC-Representative for registration

• Basic UDI-DI* • Member state where the products shall be marketed * • Summary of safety and clinical performance* • CE-Certificate (if applicable)* • Declaration of conformity* • Product description* • Label • Instruction for use • List of applied standards • Summary of preclinical evaluation (e.g. Biocompatibility testing) • If applicable, information on the OEM manufacturer • ….

• CE-Certificate (if applicable)* • Declaration of conformity* • Product description / brochure • Label • Instruction for use • List of applied standards • Summary of preclinical

evaluation (e.g. Biocompatibility testing)

* must be provided to the competent authority

MDR 2017/745 (detailed requirements in Annex VI) MDD 93/42/EEC:

* must be uploaded into EUDAMED

歐盟授權代表註冊時須提供的信息

• 基本的UDI-DI * • 產品將販售的歐盟成員國* • 產品安全和臨床性能評估綜述* • CE證書（如適用）* • 符合性聲明* • 產品描述/ 簡介 • 標籤 • 使用說明書 • 產品符合的標準清單 • 臨床前評估綜述（例：生物相容性實驗） • 如適用，還應提供OEM製造商訊息 • ….

• CE證書（如適用）* • 符合性聲明* • 產品描述/ 簡介 • 標籤 • 使用說明書 • 產品符合的標準清單 • 臨床前評估綜述（例：生物相容

性實驗）

* 必須經主管當局確認

MDR 2017/745 （附属書VI 要求事項の詳細） MDD 93/42/EEC：

* 必須提交到EUDAMED系統中

• Notified Body involved

• Certifcation by Notified Body

• Less strict surveillance

• No notified body involved

• Self-certification by manufacturer

• much more critical surveillance by

competent authority

Class IIa, IIb, III devices Class I devices

7. Dezember 2017

Competent authorities role

12

• 有認證機構審核

• 由認證機構發證

• 主管當局的監管審核相對較鬆

• 不須認證機構參與

• 由企業自我宣稱

• 主管當局的監督審查較嚴

Class IIa、IIb、III器材 Class I 器材

7. Dezember 2017

主管當局職責

13

Free Sales Certificates 4

Post-Market Surveillance

3

Incident Reporting

2

Registration Issues in Europe 1

Agenda

7. Dezember 2017

自由銷售證明 4

產品上市後監督 3

不良事故報告 2

歐盟境內產品註冊 1

議 程

7. Dezember 2017

7. Dezember 2017

European Vigilance System, Incident definition

Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.

MDD 93/42/EEC

16

incident: Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect serious incident: Any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat

MDR 2017/745

7. Dezember 2017

歐盟警戒系統， 不良事故定義

不良事故：器械的特征和性能出現任何

故障或劣化，包括標簽和使用說明中任

何可能（或可能已經）直接或者間接導

致病人、使用者或其它人死亡或其健康

嚴重惡化的缺陷。

MDD 93/42/EEC

17

不良事故: 市場上可獲得的器械若其特征或性能出現任何故障或劣化，包括人體工程學特征引起的錯誤使用，製造商提供

的信息的任何不足，和任何不良副作用。

嚴重不良事故: 任何可能（或可能已經，或已經）直接或間接導致下列情況的事件：（a）病人、使用者或其他人死亡；（b）病人、使用者或其他人的健康狀況暫時或永久嚴重惡化；（c）嚴重的公共健康威脅。

MDR 2017/745

7. Dezember 2017

Reporting timelines are no longer a Guideline but Legislation

18

MEDDEV 2.12-1 MDR 2017/745

Serious public health threat:

IMMEDIATELY (without any delay that could not be justified) but not later than 2 calendar days after awareness by the manufacturer of this threat.

IMMEDIATELY but not later than 2 calendar days after awareness by the manufacturer of this threat.

Death or unanticipated serious deterioration in state of health:

IMMEDIATELY (without any delay that could not be justified) after the manufacturer established a link between the device and the event but not later than 10 calendar days following the date of awareness of the event.

IMMEDIATELY after the manufacturer established a link between the device and the event but not later than 10 calendar days following the date of awareness of the event.

Others:

IMMEDIATELY (without any delay that could not be justified) after the manufacturer established a link between the device and the event but not later than 30 calendar days following the date of awareness of the event.

IMMEDIATELY after the manufacturer established a link between the device and the event but not later than 15 calendar days following the date of awareness of the event.

7. Dezember 2017

報告的時間線不再是指南而是法規要求

19

MEDDEV 2.12-1 MDR 2017/745

嚴重的公共健康威脅:

立即報告（若無正當理由不得延遲）， 且必須在制造商知曉該威脅後2個自然日內。

立即報告， 且在制造商知曉該威脅後2個自然日內

死亡或意外的健康狀況嚴重惡化:

立即報告（若無正當理由不得延遲）， 在制造商將器械和該事故聯系起來後， 但必須在得知該事故後10個自然日內。

立即報告 在制造商將器械和該事故聯系起來後， 但必須在得知該事故後10個自然日內

其它:

立即報告（若無正當理由不得延遲）， 在制造商將器械和該事故聯系起來後， 但必須在得知該事故後30個自然日內 。

立即報告 在制造商將器械和該事故聯系起來後， 但必須在得知該事故後15個自然日內 。

Free Sales Certificates 4

Post-Market Surveillance

3

Incident Reporting

2

Registration Issues in Europe 1

Agenda

7. Dezember 2017

自由銷售證明 4

產品上市後監督 3

不良事故報告 2

歐盟境內產品註冊 1

議 程

7. Dezember 2017

Post Marketing Surveillance - no longer a Guideline but Legislation

MDD, various Annexes mention: „systematic procedures“ to review experience gained from devices in the post-production phase

⇒ Quality Management System

MEDDEV-Guidelines on Market Surveillance:

MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System

MEDDEV 2.12/2 rev.2

Post Market Clinical Follow-up studies

MDD 93/42/EEC: Chapter VIII: Post-market surveillance, vigilance and market surveillance:

For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system proportional to the risk class…

The post-market surveillance system shall be based on a post-market surveillance plan as described in Annex III

Post-market surveillance reports for class I devices, updates when necessary and to be provided to authorities upon request.

Periodic safety update report for class IIa, IIb and III as follows

MDR 2017/745

上市後監督 – 不再是指南而是法規要求

MDD多個章節提到：”系統化程序”用於審查從器材生產后狀態獲得的經驗數據。

質量管理體系

針對市場監督的MEDDEV-Guidelines：

醫療器材警戒系統的MEDDEV 2.12 / 1 第8版指南

MEDDEV 2.12 / 2 第2版

上市後臨床跟蹤研究

MDD 93/42/EEC: 第VIII章：上市後監督、警戒和市場監督:

對於每個器材，制造商應計劃、建立、記錄、實施、維護和更新與風險等級成正比的上市後監督體系…

上市後監督應以附錄III所述的上市後監督計劃為基礎。

Class I 產品的上市後監督報告應在必要時更新，並提供給主管當局。

Class IIa、IIb和III類產品必須按以下要求提交定期安全更新報告

MDR 2017/745

7. Dezember 2017

Post Marketing Surveillance – for high(er) risk class devices

24

• Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety

update report (‘PSUR’) for each device and where relevant for each category or group of devices…

PSUR is part of the technical file PSUR shall set out: a) the conclusions of the benefit-risk determination; b) the main findings of the Post Marketing Clinical Follow-up; c) the volume of sales of the device and an estimate evaluation of the size and other

characteristics of the population using the device and, where practicable, the usage frequency of the device.

MDR 2017/745 ̶ Chapter VIII, Article 86:

7. Dezember 2017

上市後監督 ― 對較高風險等級產品

25

• Class IIa, IIb, III類產品的製造商必須為每個產品，乃至每個系列或大類的產品提供定期安全更新報告（PSUR ： Periodic Safety Update Report）

PSUR是產品技術文檔的一部分 PSUR 必須包括： a) 對產品利益-風險評估的結論。 b) 上市後臨床跟蹤的主要發現 c) 產品的銷售量，對使用該產品的人口數量和其他特征進行估計性評估，並在可行的情況

下評估產品的使用頻率。

MDR 2017/745 ̶ 第VIII章 第86条 :

7. Dezember 2017

Post Marketing Surveillance – for high(er) risk class devices

26

• class IIb and class III devices: update of the PSUR at least annually • class IIa devices: update the PSUR when necessary and at least every two years Make available the PSUR to the notified body and upon request to the competent authorities. • class III devices or implantable devices: submit PSURs to the notified body involved via

EUDAMED. The notified body shall review the report and add its evaluation to EUDAMED.

• PSURs and the evaluation by the notified body shall be made available to competent authorities via EUDAMED

MDR 2017/745 ̶ Chapter VIII, Article 86:

7. Dezember 2017

上市後監督 ― 對較高風險等級產品

27

• class IIb and class III 產品: PSUR 至少一年更新一次 • class IIa 產品: PSUR在必要時更新，但至少兩年一次 當公告機構或主管當局要求時，須提供PSUR其查看 • class III 產品或可植入式器材: 須通過EUDAMED數據庫向相關的公告機構提交PSUR報告。

公告機構須審核該報告并在EUDAMED系統中填寫對該報告的評價。 • PSUR報告和公告機構的評價都必須通過EUDAMED供主管當局查閱

MDR 2017/745 ̶ 第VIII章 第86条

Free Sales Certificates 4

Post-Market Surveillance

3

Incident Reporting

2

Registration Issues in Europe 1

Agenda

7. Dezember 2017

自由銷售證明 4

產品上市後監督 3

不良事故報告 2

歐盟境內產品註冊 1

議 程

7. Dezember 2017

7. Dezember 2017

Free Sales Certificates are needed to enable sales in certain countries e.g.:

• Egypt • Argentina • India • Brasil • Iran • Etc.

30

• FSC are also called Certificates of Marketability

• The authority certifies the compliance with the relevant legislation

• The authority certifies the marketability of the devices in the European Community

• Only available for registered devices

What are FSCs ?

7. Dezember 2017

自由銷售證明 （FSC：Free Sales Certificate） 通常在某些國家販售時 需要自由銷售證明：

• 埃及 Egypt

• 阿根廷 Argentina

• 印度 India

• 巴西 Brasil

• 伊朗 Iran

• 等等。。etc

31

• 自由銷售證明（FSC）又稱Certificate of Marketability

• 主管當局證實產品符合相關法規

• 主管當局證實產品可以在歐盟上市

• 產品通過歐盟登録審核后才可申請

什麼是自由銷售證明 （FSC）？

Free Sales Certificates – how they look like 自由銷售證明 樣式

Free Sales Certificates in view of the new MDR

• Today FSC issued by competent authority

(that register the product)

• With EUDAMED and MDR not clear

whether any changes in issuing of FSC

新MDR法規下的自由銷售證明

• 目前FSC由（產品註冊當地）主管當局簽發。

• 但在 EUDAMED 和 MDR 下，尚不確定

FSC的簽發機構是否會有變化。

MedNet GmbH, Borkstraße 10, 48163 Münster, Germany www.mednet-eurep.com / Amy.Qian@medneteurope.com

Tel +49 251 32266 0 / MP +86 132 1016 7238

Foliennummer 1Agenda議 程Foliennummer 4Foliennummer 5Agenda議 程Why do you need to register your product in Europe ?�為 什 麽 需 要 在 歐 盟 註 冊 產 品?Information needed by your EC-Representative for registration �歐盟授權代表註冊時須提供的信息Competent authorities role 主管當局職責Agenda議 程European Vigilance System, Incident definition歐盟警戒系統， 不良事故定義Reporting timelines are no longer a Guideline but Legislation��報告的時間線不再是指南而是法規要求��Agenda議 程Post Marketing Surveillance - no longer a Guideline but Legislation上市後監督 – 不再是指南而是法規要求Post Marketing Surveillance – for high(er) risk class devices上市後監督　―　對較高風險等級產品Post Marketing Surveillance – for high(er) risk class devices上市後監督　―　對較高風險等級產品Agenda議 程Foliennummer 30Foliennummer 31Free Sales Certificates �– how they look like��自由銷售證明 �樣式Free Sales Certificates in view of the new MDR新MDR法規下的自由銷售證明Foliennummer 35