CE医疗器械警戒系统(英文版)

The Medical Device Vigilance System1. PurposeThe principal purpose of the Medical Device Vigilance System (Hereinafter referred as the ‘System ’) is to improve the protection of health and safety of patients, users and others byreducing the likelihood of reoccurrence of the incident elsewhere. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents.2. ScopeThe ‘System’ applies to incidents with regard to:2.1 devices which carry the CE-mark (Hereinafter short for ‘CE product s ’) within EU2.2 devices that do not carry the CE-mark but where such incidents lead to responsibilities ofcorrective action(s), medical incident(s) and report(s) within EU relevant to ‘CE products’ mentioned above.2.3 devices which carry the CE mark outside EU.3．Responsibility3.1 The Manufacturer ’s Responsibilit ies: The Manufacturer shall start investigation once upon the incident notice is received, and find out the relationship among the responsible bodies, authorized EU representatives and their National Competent Authorities.3.2 The Authorized EU Representativ es’ Responsibilities: Once the incident notice is received, the authorized representatives within EU shall notify the Manufacturer immediately and assist him to deal with incidents, and meanwhile, submit to their National Competent Authorities the initial report, investigate outcome and the final report.3.3 The Sellers or Distributors ’ Responsibilities: The sellers or/and distributors shall report customers’ complaints and submit incident reports to the Manufacturer timely, and keep the sales records. 4．Procedure4.1 The management representative shall decide items to be reported to the local competent authorities after an analysis of incident report details, and joint investigation by biochemical and quality control departments.4.2 When the Manufacturer decides whether the incident shall be notified to the competent authorities or not, the following factors shall be considered: a) Incident typeCo.Ltd.Ref : QP-001-024 Version: C0 Page(s) 1st of 7Page(s) 2nd of 7b) Whether the incident is related to any medical device from the Manufacturer or not.c) The possibility of whether the incident is caused by defects on medical devices or itsinformation provided4.3 The management representative shall inform competent authorities, when one or more of the following outcomes are included:4.3.1 death of a patient, user or other person.4.3.2 serious deterioration in state of health of a patient, user or other person.A serious deterioration in state of health can include:a) life-threatening illness,b) permanent impairment of a body function or permanent damage to a body structure,c) a condition necessitating medical or surgical intervention to prevent a permanent impairment of a body function or structure.4.3.3 The incidents with the possible outcomes of death or health deterioration, or defects detection of the medical devices. Such a incident is called ‘Potential Incident’.4.4 In assessing the link between the device and the incident the Manufacturer should take account of:the opinion, based on available evidence, of healthcare professionals;the results of the Manufacturer's own preliminary assessment of the incident;evidence of previous, similar incidents;other evidence held by the Manufacturer.4.5 The incident report shall include the following contents:4.5.1 Any malfunction or deterioration in the characteristics and/or performance of a device4.5.2 One of device characteristics has the possibility of resulting in an incident without any malfunction or its performance deterioration. In this case, a ‘Potential Incident’report shall be conducted.4.5.3 Any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or a serious deterioration in his state of health;4.6 The Incident Report TimescaleAfter receiving the incident notice and completing the preliminary assessing report by the management representative, the Manufacturer shall inform the competent authorities within timescale as follows:a）Incident: 10 daysb）Potential Incident：30 days4.7 Competent Authorities on medical devices to be reported4.7.1 If the incident occurs in EU, it shall be reported to local competent authorities.Page(s) 3rd of 74.7.2 If it occurs outside EU, it shall be reported to competent authorities where the notifiedbody is located.4.7.3 If necessary, the Manufacturer shall, under Vigilance System, inform authorized EU representatives and other relevant authority representatives of the incident.4.7.4 The Manufacturer shall as well inform the notified body which certified their products.4.8 Systematic Recall of Products4.8.1 The Manufacturer shall report to the competent authority when the recall is due to any technical or medical reasons.4.8.2 In a Recall, a ‘Advisory Notice’ shall be issued and further be submitted to the competentauthority in related country.4.8.3 The General Manager finalizes the product recall and issue of the ‘Advisory Notice’.4.9 Once the complaints from customers in local authority where the incident occurred, and reports else are received, the Manufacturer shall fulfill an initial report. Its details please see ‘The Initial Incident Report’.4.1O Investigation after the initial report4.1O.1 The Manufacturer shall conduct incident investigation based on the initial report, and inform the competent authority of the latest progress.4.1O.2 The Manufacturer shall report to the competent authority immediately if the investigationcan’t be carried out timely.4.11 Outcome of An Investigation and Follow-up4.11.1 Normally, the Manufacturer shall take the action necessary following the investigation, including consultation with the competent authority and notified body, and recall products and so on.4.11.2 There shall be a final report to the competent authority which is a written statement of the outcome of the investigation and of any action. Details please refer to ‘The Final Incident Report’.4.11.3 Examples of actions may include:a) no action;b) additional surveillance of devices in use;c) Issuance of information to users, like ‘Advisory notice’.d) Preventive action on future production;e) Field safety corrective action.f) Recall of products4.12 Link Procedure between Manufacturer and Authorized EU Representative4.12.1 Authorized EU Representative Name and Addressa）Authorized EU Representative Nameb）Postal Address, Postal Code, City, Tel, Fax, E-mail, Nation.4.12.2 The Responsibility of the Manufacturera）Ensure that each technical document of ‘CE P roducts’ provided to authorized EU Representative is in valid version.b）If the incident occurs seriously in EU, the Manufacturer shall find out reasons, and fulfill the initial report, the investigation outcome and the final report together with authorized EU representative on time, and finally send to him.c）If a serious incident occurs outside EU, the same procedures above shall apply to the Manufacturer as well, and finally inform authorized representatives.d）To guarantee the valid link of documents revising and issuance of notices to authorized EU representatives (other regions also included), the sales department of the Manufacturer shall update their latest postal address. Meanwhile, other valid methods or channels shall be noted and written in agreements signed with authorized EU representatives.4.12.3 The Responsibility of the Authorized EU Representativesa）The authorized EU representatives shall have the responsibility for registering the Manufacturer’s ‘CE Products’ to the competent authority.b）The authorized EU representatives shall keep technical documents of the Manufacturer’s ‘CE Products’ for at least 5 years after the date of manufacture of the final lot of suchproducts. What’s particular, among them technical documents of orthopedic productsshall be saved for at least 10 years after the date of manufacture of the final lot.c）The authorized EU representatives shall notify any information of the Manufacturer’s ‘CE Products’ from their competent a uthorities, their customers’ complaints, or other activities related in EU to the Manufacturer.d）The authorized EU representatives shall assist the Manufacturer to deal with the incidents related to his medical devices, and submit to their competent authorities the initial report, the investigation outcome and the final report.5、Related documents5.1 the Directive for Medical Devices (MDD), 93/42/EEC5.2 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM,MEDDEV 2.12-1 rev75.3 Report on Incident of Advisory Notice（HS/QP-001—021）6、AnnexesAnnex 1: List of EU Competent Authorities (FEB 1998)Annex 2: The Initial Incident ReportAnnex 3: The Final Incident ReportAnnex 1:LIST OF COMPETENT AUTHORITIES (February 1998)Annex 2:The Initial Incident Report1. Competent AuthorityAddress: ____________________________________________________________2. Manufacturer InformationA) Factory: Authorized Representative within EU:B) Address:C) Contact Person:D) Tel:E) Fax:F) Date of Report3. Incident Information & Manufacturer’s Preliminary CommentsA) Product Name:B) Product Classification:C) Model & Dimensions:D) Lot No.:E) Annex:F) Certificate No.:G) Any similar incident occurred before? If so, which country did it take place? Incident Report No.:Notified Body:Address:Tel:Date of Report:H) Incident Date:I) Incident Content:J) Consequence( like occurrence of death, health deterioration):K) Preliminary Comment by Manufacturer:L) Product’s cur rent position (if available)M) Date of Follow-up ReportN) Corrective Action:O) Scheduled Time:Annex 3:The Final Incident Report1．The Competent AuthorityAddress: ____________________________________________________________ 2．Manufacturer InformationA) Factory: Authorized Representative within EU:B) Address:C) Contact Person:D) Tel:E) Fax:F) Date of Report:3．Incident Information & Manufacturer’s Final Report:A) Product Name:B) Product Classification:C) Model & Dimensions:D) Lot No.:E) Annex:F) Certificate No.:G) Any similar incident occurred before? If so, which country did it take place?Incident Report No.:Notified Body:Address:Tel:Date of Report:H) Effect from similar incident on current report:I) Incident in (Country), Incident Report No.:J) Incident Notified Body:Address:Tel:Fax:K) EU Countries already covered by this product:L) Date of the Initial Report:M) Investigation Outcome by Factory:N) Further InvestigationO) Corrective Action:P) Proposed Date of Follow-up ReportQ) Corrective Action:R) Scheduled Time:。