a）事故：10天；                                                                                                                                            


b）準(zhǔn)事故：30天。 


                                                                                                                        


4.7   應(yīng)報告的醫(yī)療器械主管當(dāng)局


                                                                                                                                                            


4.7.1 如發(fā)生在歐盟國家，應(yīng)向器械發(fā)生事故的國家的主管當(dāng)局報告。


                                                                                                                                                            


4.7.2  如發(fā)生在歐盟以外的其他國家,應(yīng)向公告機構(gòu)所在國的主管當(dāng)局報告。



 


4.7.3 必要時，在警戒系統(tǒng)下制造商應(yīng)通知歐盟的授權(quán)代表及其他機構(gòu)代表報告事故。



 


4.7.4 制造商也應(yīng)報告對其進(jìn)行認(rèn)證的公告機構(gòu)。


                                                                                                                                                            


4.8產(chǎn)品的系統(tǒng)性收回        


                                                                                                                                                  


4.8.1 技術(shù)上或醫(yī)學(xué)上的原因而導(dǎo)致產(chǎn)品的收回,應(yīng)通知主管當(dāng)局。


                                                                        

4.8.2 產(chǎn)品的收回，應(yīng)發(fā)出《忠告性通知》并發(fā)送至有關(guān)國家的主管當(dāng)局。


4.8.3 總經(jīng)理負(fù)責(zé)對產(chǎn)品的收回及忠告性通知發(fā)送事宜，作出最終決定。


                                                                                                                                                            


4.9在收到了來自主管當(dāng)局顧客的抱怨和其他方面的事故信息報告后，制造商應(yīng)有一份初始報


告，初始報告的內(nèi)容詳見《初始報告表》。


                                                                                                                                            


4.1O  初始報告后的調(diào)查     


                                                                                                                                                  


4.1O.1制造商在初始報告的基礎(chǔ)上，對事故進(jìn)行調(diào)查，并及時向權(quán)威機構(gòu)報告進(jìn)展情況。



 


4.1O.2如果制造商無法對事故進(jìn)行調(diào)查，則應(yīng)立即通知主管當(dāng)局。    


                                                                                                                                                  


4.11調(diào)查結(jié)論及跟蹤         


                                                                                                                                  


4.11.1正常情況下，制造商在調(diào)查后依據(jù)調(diào)查結(jié)果采取適當(dāng)措施，包括向當(dāng)局或公告機構(gòu)咨


詢和收回產(chǎn)品等。  


4.11.2制造商應(yīng)有一份最終報告，對調(diào)查的結(jié)果和采取的措施做出書面陳述，遞交給有關(guān)的


主管當(dāng)局最終報告的內(nèi)容見《最終報告表》。


                                                                                                                                        


4.11.3調(diào)查的結(jié)論可能包括如下內(nèi)容：                                                                                                                                                   


a)無措施。                                                                                                                                                 


b)在使用中加強監(jiān)督。                                                                                                                                                 


c)向使用者發(fā)布信息，如忠告性通知。                                                                                                                                                


d)以后生產(chǎn)中的糾正措施。                                                                                                                                             


e)對正在使用器械的糾正措施。                                                                                                                                         


f)收回。


                                                                                                                                  


4.12  制造商與歐盟授權(quán)代表的聯(lián)系程序 


                                                                                                                                                  


4.12.1歐盟授權(quán)代表的名稱、地址。


a）歐盟授權(quán)代表的名稱；                                                                                                                                              


b）歐盟授權(quán)代表的郵政通訊地址。


                                                                                                                                  


4.12.2制造商應(yīng)做的工作。                                                                                                                                                          


a）確保向歐盟授權(quán)代表提供每一類帶有CE標(biāo)志產(chǎn)品的技術(shù)文檔為有效版本。                                                                                                                        


b）在歐盟境內(nèi)發(fā)生的嚴(yán)重事故，應(yīng)及時和歐盟授權(quán)代表一起調(diào)查原因，并完成


初始報告、調(diào)查結(jié)果、最終報告并傳遞給歐盟授權(quán)代表。                                                                                                                                 


c）在歐盟境外發(fā)生的嚴(yán)重事故，也應(yīng)在完成上述工作以后及時通告授權(quán)代表。


d）為保證文件的修改和通告的發(fā)布，公司銷售部應(yīng)保持歐盟授權(quán)代表（包括其它區(qū)域）


最新郵政地址。在與歐盟授權(quán)代表簽訂的協(xié)議中也應(yīng)明確文件或其它信息傳遞的有效途徑。