BSI將正式受理MDR申請

BSI最近已宣布，經英國藥品及保健產品管理局（MHRA）核准授權，BSI已成為全球首家獲得歐盟醫療器材法規（MDR）（EU 2017/745）認可的公告機構（Notified Body, NB）。

BSI（英國公告機構，NB 0086）將從2019年6月3日起，正式受理MDR申請。BSI計畫在未來幾個月安排報價等工作，預計將於2020年1月開始進行交付。無論您的MDD證書是由BSI英國公告機構（NB 0086）或BSI荷蘭公告機構（NB 2797）核發，BSI現在均可以為客戶提供全範圍（full scope）的MDR符合性評鑑（conformity assessment）。如需進一步瞭解BSI授權範圍，請造訪歐盟  NANDO 資訊系統進行查詢。對於因需要外部諮詢（consultations）、未發佈通用規範（common specifications），以及目前未在監管系統內有被公認的專業知識而導致的申請進度延遲，均不在BSI的控制範圍內。

請注意，目前我們仍將優先處理現行醫療器材指令（MDD）的相關申請；包括變更、更新、擴大範圍等。這項優先安排可以確保BSI客戶的產品在歐盟上市，同時滿足MDR規定的過渡時間表。

英國脫歐和MDR

我們了解您擔憂英國脫歐會對您向英國公告機構申請MDR產生影響，BSI想與您分享我們目前的理解：英國目前的政治情勢表明，英國將與歐盟達成協議，並有實施過渡期。在這種情況下，BSI 英國公告機構在過渡期（目前相關文件顯示為2020年12月底）結束前仍是歐盟公告機構。因此，我們計畫啟動BSI英國公告機構（NB 0086）下的MDR的驗證工作。

歐盟法規允許自願變更公告機構。根據MDR第58條 / IVDR第53條規定，當BSI荷蘭公告機構（NB 2797）獲得MDR認可後，英國公告機構（NB 0086）下的申請可變更至荷蘭公告機構（NB 2797）。具體變更流程BSI也將在適當的時候公佈。歐盟MDCG 2018-8指導文件指出：在自願進行證書轉移的情況下，即將退出歐盟的公告機構所進行的符合性評鑑活動，可由新加入的歐盟公告機構繼續受理。BSI認為，如果將MDR申請從NB 0086遷移至NB 2797，也可以適用這些原則。

BSI對上述我們採行的方法充滿信心。但是，仍有一些與時間相關的低風險因素不受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。對於該情況的解決方案是： NB 0086先完成MDR的申請工作，在NB 2797獲得認可後再進行遷移
  • 其他未包含在上述所列的不可預見的情況

請注意：如何選擇將由貴公司根據您自身的情況決定。

如何能獲得更多資訊？

請與BSI企業服務部團隊聯繫以啟動報價流程，他們將在第一時間回答您的問題。此外，我們建議使用以下所列的免費資源：

  • BSI為您的MDR轉版所設置的專屬網站

BSI Transition-MDR

 

英文版本：

BSI to begin accepting applications for MDR 

BSI recently announced that we were the first EU notified body to achieve designation, under the Medicines and Healthcare products Regulatory Agency (MHRA) to the Medical Device Regulation (MDR) (EU 2017/745).

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 Applications which rely on external consultations, unpublished common specifications or expertise which is not currently available within the regulatory system will experience an additional delay to the application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.

Brexit and MDR 

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 NB2797 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.