歐洲理事會已經批準了一項提案，旨在延長MDR（歐盟醫療器械法規）的醫療器械過渡期，并取消MDR和IVDR（歐盟體外診斷醫療器械法規）關于停售現有產品的規定。
3月7日，歐洲理事會以27:0的投票結果，通過了歐洲議會和歐盟委員會提出的這一提案。2月16日，歐洲議會以537:3的投票結果，批準延遲MDR的過渡期，以此避免經濟區內數以萬計的產品被迫停售的可能。
瑞典衛生保健部長Acko Ankarberg Johansson在新聞稿中提到，“今天我們通過了一項提案，使行業能夠繼續為市場引入必要的醫療器械，并保證患者能夠安全地使用醫療器械。”
該提案已于1月6日經歐盟委員會批準。MDR的過渡期將在接下來的幾年內終止。隨著終止日期的逼近，利益相關者對醫療器械的供應、公告機構的服務容量和制造商的準備狀態感到擔憂，這促成了延長過渡期的舉措。
接下來，這一提案將發布在《歐盟官方公報》上，屆時提案將立即生效。據此，III類器械和IIb類植入性器械的過渡期將延長至2027年12月，IIb類非植入性器械、IIa類和I類器械需要在2028年12月之前完成過渡，III類定制植入性器械需要在2026年5月之前完成過渡，MDR和IVDR針對產品停售的要求將不再適用。
Qserve集團的執行董事Gert Bos提醒醫療器械制造商，即使MDR的過渡期延期，也沒有時間可以浪費，制造商應當努力向公告機構最終確定相關資料，并確保臨床數據能夠充分證明產品預期用途的實現。
“延期旨在為公告機構預留足夠的時間，使其能夠利用稀缺的資源，完成所有必要的符合性評估，”他告訴Focus。“延期的初衷并非是為行業留出更多時間，制造商應當在大約一年的時間內準備好審核資料，這樣才能與合作的公告機構簽署審核合同。”
Team-NB副總裁、TÜV SÜD監管戰略全球負責人Sabina Hoekstra-van den Bosch特別指出，醫療器械協調小組（MDCG）在其MDCG 2022-14立場文件中提出了幾項措施，幫助公告機構更高效地利用它們的可用資源。她說道，當大家把注意力都集中在法規的修改時，這些措施可能會被置于次要地位，她對此表示擔憂。
Hoekstra-van den Bosch告訴Focus，“要想成功實現過渡期延長的作用，MDCG 2022-14提出的部份措施仍然必須付諸行動，如果目前實施狀態還不理想的話。”“以下MDCG 2022-14提議有助于成功實施修訂后的法規：例如，幫助制造商和公告機構開展結構性對話；在MDR與原指令相比沒有變化的情況下，利用公告機構此前根據原指令已經評估的證據；審核現有的MDCG指南，修改/刪去不清晰的內容或其他有改善空間的規定，向制造商和公告機構明確MDCG新指南的實施時間。”
這則消息不僅僅讓歐洲的利益相關者松了一口氣。大西洋彼岸的醫療器械游說集團AdvaMed也對歐洲理事會通過提案的決定作出了評價。
“歐洲理事會今天的投票結果給了醫療行業一個繼續挽救和改善歐洲患者生命的機會。在全球范圍內，歐盟市場是提供優質患者護理服務、研發及器械獲取通道的卓越市場之一，每年服務數百萬患者，因此正確實施MDR至關重要,”AdvaMed的首席執行官Scott Whitaker在一篇新聞稿中說道。“我們與MedTech Europe合作，充分解決一些遺留問題，包括進一步明確向公告機構提交申請的流程以及如何證明證書有效期的延期。”
“我們也在努力解決實際的執行問題，比如歐盟市場上罕見器械和小眾器械的可及性，”他補充道。“這個決定為幫助世界各地的患者向前邁出了堅定的一步，AdvaMed將繼續支持穩健的歐盟監管計劃，用及時、可預測的方式促進創新并改善患者獲取治療的機會。”
Gert Bos是RAPS的主席，Sabina Hoekstra-van den Bosch是RAPS的一名理事。RAPS是一個無黨派、非營利的專業協會。他們的評論僅代表個人觀點。
© 2023 Regulatory Affairs Professionals Society.
英文原文
The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
On 7 March, the Council voted 27-0 to adopt the measure put forward by the European Parliament and Commission. The parliament voted 537-3 on 16 February to push back the MDR transition period to avoid potentially forcing tens of thousands of products off the market in the economic region. (RELATED: European Parliament votes to extend MDR transition period, Regulatory Focus, 16 February 2023)
“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” Acko Ankarberg Johansson, Swedish minister for health care, said in a press release.
The measure had already been approved by the European Commission on 6 January. With the looming MDR transition deadlines coming up in the next few years, stakeholders have raised concerns about the supply of medical devices, notified body capacity and manufacturer preparedness, which prompted the move to extend the transition period. (RELATED: European Commission moves to delay MDR transition, 6 January 2023)
The measure will next be published in the Official Journal of the European Union, at which point it will go into immediate effect. It would extend the transition deadline for Class III and IIb implantable devices to December 2027; Class IIb non-implantable devices, and Class IIa and Class I devices would need to transition by December 2028; Class III custom-made implantable devices would need to transition by May 2026; and the sell-off requirements for products under MDR and IVDR will no longer apply.
Gert Bos, executive director of the Qserve Group, cautioned medical device manufacturers that even with the MDR deadline extensions, there’s no time to waste and they should be working diligently to finalize their dossiers to notified bodies (NB) and ensure they have enough clinical data to prove their product works as intended.
“The intention of the extension is to allow sufficient time for the notified bodies to use their scarce resources to complete all needed conformity assessments,” he told Focus. “It is not intended to give much time for industry, as their dossiers should be ready for review in about a year’s time in order to get a signed agreement for the work from the notified body they work with.”
Sabina Hoekstra-van den Bosch, vice-president of Team-NB and global director of regulatory strategy at TÜV SÜD, noted that the Medical Device Coordination Group (MDCG) has proposed several measures in their MDCG 2022-14 position paper that allow notified bodies to use their available capacity more efficiently. She said she is worriee that those measures may be pushed into the background as all the attention is focused on legislative changes.
“To allow extension of the transition timelines to be successful, it is still necessary that some proposed measures of MDCG 2022-14 be put into action, if this has not happened yet,” Hoekstra-van den Bosch told Focus. “Proposals from 2022-14 that could contribute to the success of the amending regulation are for instance: allowing structured dialogue between manufacturers and notified bodies, leveraging evidence that notified bodies have already assessed under the Directives and where there is no change in the MDR as compared to the Directives, review of existing MDCG guidance and amending/removing unclarities and/or other provisions that could be improved and giving clarity to manufacturers and notified bodies on when a new MDCG guidance document will become applicable.”
The news was not just a sigh of relief for stakeholders in Europe. Across the pond, the medical device lobby group AdvaMed also commended the EC’s decision to adopt the measure.
“Today’s vote by the EU Council gives the medtech industry the opportunity to continue saving and improving the lives of patients in Europe. The EU is one of the world’s preeminent markets for quality patient care, R&D, and access, serving millions of patients annually, so it’s critical that MDR implementation is done correctly,” said AdvaMed CEO Scott Whitaker in a press release. “Together with MedTech Europe, we’re working to fully address several remaining issues, including a clearer process for submitting applications to notified bodies, as well as greater clarity on how certificate extensions can be demonstrated.”
“We are also working to address practical implementation issues, such as access to ‘orphan’ and niche devices in the EU market,” he added. “This is a strong step forward for patients worldwide, and AdvaMed will continue to champion a robust EU regulatory scheme that fosters innovation and patient access to treatment in a timely and predictable manner."
Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.
© 2023 Regulatory Affairs Professionals Society
