BSI最近已宣布，經(jīng)英國藥品和健康產(chǎn)品管理局（MHRA）批準(zhǔn)授權(quán)，BSI已成為全球首家獲得歐盟醫(yī)療器械法規(guī)（MDR）（EU 2017/745）發(fā)證資質(zhì)的歐盟公告機(jī)構(gòu)。

2019年6月3日起，BSI正式受理MDR申請

BSI（英國公告機(jī)構(gòu)，NB 0086）將從2019年6月3日起，正式受理MDR申請。BSI計(jì)劃在未來幾個月安排報(bào)價等工作，預(yù)計(jì)將于2020年1月開始進(jìn)行交付。無論您的MDD證書是由BSI英國公告機(jī)構(gòu)（NB 0086）或BSI荷蘭公告機(jī)構(gòu)（NB 2797）簽發(fā)，BSI現(xiàn)在均可以為客戶提供全范圍的MDR審核。如需進(jìn)一步了解BSI授權(quán)范圍，請?jiān)L問歐盟NANDO網(wǎng)站進(jìn)行查詢。對于因需要外部咨詢（consultations）、未發(fā)布通用規(guī)范，以及目前未在監(jiān)管體系內(nèi)有被公認(rèn)的專業(yè)知識而導(dǎo)致的申請進(jìn)度延遲，均不在BSI的控制范圍內(nèi)。

請注意，BSI目前仍將優(yōu)先處理MDD指令的相關(guān)申請，包括變更、續(xù)證、擴(kuò)證等。此優(yōu)先級安排可確保BSI客戶的產(chǎn)品在歐盟上市，同時滿足MDR規(guī)定的過渡時間表。

We would now like to inform you that we are accepting applications under the MDR for our UK Notified Body (0086) from 3 June 2019. BSI will begin to process quote requests and look to schedule the work over the coming months, with the delivery of work expected to commence in January 2020. BSI will now be able to provide conformity assessments to the full scope of the MDR, for BSI Directive clients under either our UK or Netherlands Notified Bodies. For further details on BSI’s scope, please visit the NANDO information system. Applications which rely on external consultations, unpublished common specifications or expertise which is not currently available within the regulatory system will experience an additional delay to the application process, unfortunately, this is out of BSI control.

Please be aware that our current priority remains those all current applications and work under the Directives; this includes changes, renewals, extension to scope etc. This priority is to ensure that our clients maintain market access and meet the transition timelines stated in the MDR.

英國脫歐和MDR：
我們了解客戶對英國脫歐和BSI英國公告機(jī)構(gòu)MDR發(fā)證資質(zhì)的擔(dān)憂。BSI想與您分享我們目前的理解：英國目前政治形勢表明，英國將與歐盟達(dá)成一項(xiàng)協(xié)議，并有實(shí)施過渡期。在這種情況下，BSI 英國公告機(jī)構(gòu)在過渡期（目前相關(guān)文件顯示為2020年12月底）結(jié)束前仍是歐盟公告機(jī)構(gòu)。因此，我們計(jì)劃啟動BSI英國公告機(jī)構(gòu)（NB 0086）下的MDR的認(rèn)證工作。

歐盟法規(guī)允許自愿更改公告機(jī)構(gòu)。根據(jù)MDR法規(guī)第58 條款，以及 IVDR法規(guī)第53條款，當(dāng)BSI荷蘭公告機(jī)構(gòu)（NB 2797）獲得MDR認(rèn)證資質(zhì)后，英國公告機(jī)構(gòu)（NB 0086）下的申請可變更至荷蘭公告機(jī)構(gòu)（NB 2797）。具體變更流程BSI也將在適當(dāng)?shù)臅r候公布。歐盟MDCG 2018-8指導(dǎo)文件指出：在自愿進(jìn)行證書轉(zhuǎn)移的情況下，即將退出歐盟的公告機(jī)構(gòu)所進(jìn)行的符合性審核的活動，可由新加入歐盟的公告機(jī)構(gòu)繼續(xù)受理。BSI認(rèn)為，如果將MDR申請從NB 0086遷移至NB 2797，也可以適用這些原則。

BSI對英國和荷蘭之間的證書轉(zhuǎn)移方法充滿信心。但是，仍有一些與時間相關(guān)的低風(fēng)險因素不受BSI掌控。
NB 2797可能無法在2020年5月之前完成一些正在申請過程中的客戶遷移。對于該情況的解決方案是： NB 0086先完成MDR的申請工作，在NB 2797獲得資質(zhì)后再進(jìn)行遷移。
其他未包含在上述所列的不可預(yù)見的情況

請注意：如何選擇將由貴公司根據(jù)您自身的情況決定

We are aware of concerns around Brexit and MDR applications into a UK notified body, we would like to share our current understanding. The situation in UK politics denotes that a deal should be agreed, and the transition period implemented. In this situation, BSI UK would remain an EU Notified Body until the end of the transition, currently documented as the end of December 2020. Therefore, we plan to initiate MDR work under the Notified Body 0086.

The EU Regulations allow for a voluntary change of Notified Body. Applications lodged with NB 0086 will be able to change to Netherlands NB 2797 following Article 58 MDR/53 IVDR when the BSI NL notified body is designated. Full details of the process will be published in due course of time. The guidance document MDCG 2018-8 states that an incoming Notified Body can take into account the conformity assessment activities conducted by the outgoing Notified Body in the context of voluntary certificate transfers. BSI believes that these principles can also be applied if and when an application is moved from NB 0086 to NB 2797.

BSI has a high level of confidence in our approach. However, there is a small risk relating to timing that we cannot fully control.
NB 2797 may not be designated in time to complete an in-application move to NB 2797 prior to May 2020. Our contingency plan in this scenario will be to complete MDR applications in NB 0086 and move to NB 2797 later once we have achieved designation.
Other unforeseen developments that may not allow the above process.

Please NOTE: it is your commercial decision for how you wish to proceed.