歐盟委員會(huì)醫(yī)療器械協(xié)調(diào)小組（MDCG）上周四（2019年10月17日）發(fā)布了一份最終評(píng)估表，供相關(guān)當(dāng)局根據(jù)歐盟醫(yī)療器械法規(guī)（MDR）（2020年5月施行）和體外診斷醫(yī)療器械法規(guī)（IVDR）（2022年5月施行）指定符合性評(píng)估機(jī)構(gòu)（CAB）和公告機(jī)構(gòu)（NB）。

該表格中的空白處用于描述由指定當(dāng)局進(jìn)行的評(píng)估，并說(shuō)明所有糾正和預(yù)防措施（CAPA）是否已得到適當(dāng)處理并在必要時(shí)予以實(shí)施。

指定當(dāng)局還可以列出有關(guān)組織要求和一般要求、質(zhì)量管理體系要求、以及資源和過(guò)程要求等方面的不符合項(xiàng)及其對(duì)符合性評(píng)估機(jī)構(gòu)和公告機(jī)構(gòu)提出的整改措施以及糾正和預(yù)防措施（CAPA）的評(píng)估結(jié)果。

除了此次發(fā)布的這份表格，MDCG最近還發(fā)布了一系列指南文件，其中涉及基于MDR/IVDR的軟件資格和分類、過(guò)渡性條款以及醫(yī)療器械專家小組指定等方面。

除了符合性問(wèn)題外，能否在明年5月份之前根據(jù)MDR指定足夠多公告機(jī)構(gòu)的問(wèn)題仍然存在。畢竟到目前為止，僅僅指定了5家公告機(jī)構(gòu)。

Emergo咨詢公司表示，目前根據(jù)醫(yī)療器械指令（MDD，93/42/EEC）指定的公告機(jī)構(gòu)有56家，而據(jù)今年9月30日的MDCG利益相關(guān)者會(huì)議透露，這些公告機(jī)構(gòu)中只有39家正在尋求MDR框架下的指定。

“這意味著其他17家公告機(jī)構(gòu)的醫(yī)療器械CE標(biāo)識(shí)認(rèn)證的未來(lái)形勢(shì)尚不明朗。在這17家公告機(jī)構(gòu)中，有7家位于土耳其和瑞士。”目前尚不清楚歐盟與土耳其/瑞士之間的基于指令的當(dāng)前協(xié)議是否會(huì)繼續(xù)有效。

The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022.

The form includes space to describe the assessment carried out by the designating authority and whether all corrective and preventive actions (CAPAs) have been appropriately addressed and, where required, implemented.

Designating authorities can also list non-conformities and their assessments of the corrections and CAPAs proposed by the CAB/NB related to organizational and general requirements, quality management system requirements, and resource and process requirements.

The release of the form is part of a flurry of recent guidance documents from the MDCG, including guidance on the qualification and classification of software under MDR and IVDR, transitional provisions and designating expert device panels.

In addition to questions on compliance, questions still linger on whether there will be enough NBs designated under MDR by next May. Just five NBs have been designated so far.

According to the consulting group Emergo, currently there are 56 NBs designated for the Medical Devices Directive, while at the MDCG stakeholders meeting of 30 September, only 39 of these current NBs are also seeking designation under MDR.

“That means that the future CE Mark certifications for medical devices of 17 Notified Bodies is unclear. Seven of these entities are based in Turkey and Switzerland,” and it’s unclear if the current agreements between the EU and Turkey and Switzerland regarding the directives will remain in place.