" EU於2017年5月頒布了Medical Device Regulation (MDR),MDR合併且取代了既有的Medical Device Directive (MDD, 93/42/EEC) 和 Active Implantable Medical Devices (AIMD, 90/385/EEC),不得不說這是個相當重大的變革,所以無論是預計要進入歐洲市場還是要維持既有的CE認證,都需要及早因應MDR的變化! "
MDR的過渡期從生效日 2017 年 5 月 25 日起算 3 年至 2020 年 5 月 26 日止.在此之後,有 MDD和AIMD證書的醫療器材仍可在市面上販售,直到 2024 年 5 月 26 日為止。MDR除了合併MDD與AIMD既有的內容之外又增加了不少新事項,因此我整理了MDR一些重要的改變給大家作參考:
- Product scope expansion: 醫療器材定義放寬,將涵蓋到部分"類醫材"(像是沒有臨床功效的產品,如: cosmetic contact lenses) .
- Reclassification of devices according to risk, contact duration and invasiveness: 將針對醫材的風險,接觸人體時間與侵入性來做分類分級,像是MDR ANNEX VIII 的rule 8提及"All implantable devices and long-term surgically invasive devices are classified as class IIb ...",隨著植入部位不同有些還會被分類至class III,不難觀察到歐盟對於植入式醫材的謹慎.
- Systematic clinical evaluation of Class IIa and Class IIb medical devices: 在MDR Article 61和ANNEX XIV Part A中都花了不少篇幅在說明Clinical Evaluation的做法;此外,歐盟為了避免在MDD轉MDR的過程中發生空窗期,發布了MEDDEV 2.7/1 revision 4來規範廠商如何產出Clinical Evaluation Plan and Report,因此醫材廠商需要重新整備Clinical Evaluation Report (CER)來滿足現行的規範要求.(不妨可參考醫循|MDDSN所提出的服務辦法,在常見問答Q3中)
- More rigorous clinical evidence for class III and implantable medical devices: 在MDR Article 61 的第4點提及"In the case of implantable devices and class III devices, clinical investigations shall be performed, except if (1). the device has been designed by modifications of a device already marketed by the same manufacturer, (2). the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and (3).the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements." ,因此新上市的植入式醫材和Class III醫材基本上都需要提供人體臨床數據.
- Implementation of unique device identification (UDI)
- More rigorous surveillance by Notified Bodies: MDR對於Notified bodies的責任與義務要求更多了,在加上台灣能提供MDR認證的Notified bodies不多,因此日後Notified bodies審查與稽核的管控力道加大是完全可以預期的.
- No “grandfathering” provisions: 不管您的醫材產品在歐洲已經賣了十幾年還是幾十年,新版MDR上路後還是必須要滿足MDR的規範,沒有醫材產品可以豁免.
引用資料:
- “ MDDSN | 醫循 — 提供醫療器材商品化一條可依循的開發取證途徑! ”
- Medical Device Regulation (MDR); Regulation (EU) 2017/745
- MEDDEV 2.7/1 revision 4
- Medical Device Regulation (MDR); Regulation (EU) 2017/745
- MEDDEV 2.7/1 revision 4
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