歐洲理事會(huì)已經(jīng)批準(zhǔn)了一項(xiàng)提案，旨在延長(zhǎng)MDR（歐盟醫(yī)療器械法規(guī)）的醫(yī)療器械過(guò)渡期，并取消MDR和IVDR（歐盟體外診斷醫(yī)療器械法規(guī)）關(guān)于停售現(xiàn)有產(chǎn)品的規(guī)定。
3月7日，歐洲理事會(huì)以27:0的投票結(jié)果，通過(guò)了歐洲議會(huì)和歐盟委員會(huì)提出的這一提案。2月16日，歐洲議會(huì)以537:3的投票結(jié)果，批準(zhǔn)延遲MDR的過(guò)渡期，以此避免經(jīng)濟(jì)區(qū)內(nèi)數(shù)以萬(wàn)計(jì)的產(chǎn)品被迫停售的可能。
瑞典衛(wèi)生保健部長(zhǎng)Acko Ankarberg Johansson在新聞稿中提到，“今天我們通過(guò)了一項(xiàng)提案，使行業(yè)能夠繼續(xù)為市場(chǎng)引入必要的醫(yī)療器械，并保證患者能夠安全地使用醫(yī)療器械。”
該提案已于1月6日經(jīng)歐盟委員會(huì)批準(zhǔn)。MDR的過(guò)渡期將在接下來(lái)的幾年內(nèi)終止。隨著終止日期的逼近，利益相關(guān)者對(duì)醫(yī)療器械的供應(yīng)、公告機(jī)構(gòu)的服務(wù)容量和制造商的準(zhǔn)備狀態(tài)感到擔(dān)憂，這促成了延長(zhǎng)過(guò)渡期的舉措。
接下來(lái)，這一提案將發(fā)布在《歐盟官方公報(bào)》上，屆時(shí)提案將立即生效。據(jù)此，III類器械和IIb類植入性器械的過(guò)渡期將延長(zhǎng)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(guò)渡，III類定制植入性器械需要在2026年5月之前完成過(guò)渡，MDR和IVDR針對(duì)產(chǎn)品停售的要求將不再適用。
Qserve集團(tuán)的執(zhí)行董事Gert Bos提醒醫(yī)療器械制造商，即使MDR的過(guò)渡期延期，也沒(méi)有時(shí)間可以浪費(fèi)，制造商應(yīng)當(dāng)努力向公告機(jī)構(gòu)最終確定相關(guān)資料，并確保臨床數(shù)據(jù)能夠充分證明產(chǎn)品預(yù)期用途的實(shí)現(xiàn)。
“延期旨在為公告機(jī)構(gòu)預(yù)留足夠的時(shí)間，使其能夠利用稀缺的資源，完成所有必要的符合性評(píng)估，”他告訴Focus。“延期的初衷并非是為行業(yè)留出更多時(shí)間，制造商應(yīng)當(dāng)在大約一年的時(shí)間內(nèi)準(zhǔn)備好審核資料，這樣才能與合作的公告機(jī)構(gòu)簽署審核合同。”
Team-NB副總裁、TÜV SÜD監(jiān)管戰(zhàn)略全球負(fù)責(zé)人Sabina Hoekstra-van den Bosch特別指出，醫(yī)療器械協(xié)調(diào)小組（MDCG）在其MDCG 2022-14立場(chǎng)文件中提出了幾項(xiàng)措施，幫助公告機(jī)構(gòu)更高效地利用它們的可用資源。她說(shuō)道，當(dāng)大家把注意力都集中在法規(guī)的修改時(shí)，這些措施可能會(huì)被置于次要地位，她對(duì)此表示擔(dān)憂。
Hoekstra-van den Bosch告訴Focus，“要想成功實(shí)現(xiàn)過(guò)渡期延長(zhǎng)的作用，MDCG 2022-14提出的部份措施仍然必須付諸行動(dòng)，如果目前實(shí)施狀態(tài)還不理想的話。”“以下MDCG 2022-14提議有助于成功實(shí)施修訂后的法規(guī)：例如，幫助制造商和公告機(jī)構(gòu)開(kāi)展結(jié)構(gòu)性對(duì)話；在MDR與原指令相比沒(méi)有變化的情況下，利用公告機(jī)構(gòu)此前根據(jù)原指令已經(jīng)評(píng)估的證據(jù)；審核現(xiàn)有的MDCG指南，修改/刪去不清晰的內(nèi)容或其他有改善空間的規(guī)定，向制造商和公告機(jī)構(gòu)明確MDCG新指南的實(shí)施時(shí)間。”
這則消息不僅僅讓歐洲的利益相關(guān)者松了一口氣。大西洋彼岸的醫(yī)療器械游說(shuō)集團(tuán)AdvaMed也對(duì)歐洲理事會(huì)通過(guò)提案的決定作出了評(píng)價(jià)。
“歐洲理事會(huì)今天的投票結(jié)果給了醫(yī)療行業(yè)一個(gè)繼續(xù)挽救和改善歐洲患者生命的機(jī)會(huì)。在全球范圍內(nèi)，歐盟市場(chǎng)是提供優(yōu)質(zhì)患者護(hù)理服務(wù)、研發(fā)及器械獲取通道的卓越市場(chǎng)之一，每年服務(wù)數(shù)百萬(wàn)患者，因此正確實(shí)施MDR至關(guān)重要,”AdvaMed的首席執(zhí)行官Scott Whitaker在一篇新聞稿中說(shuō)道。“我們與MedTech Europe合作，充分解決一些遺留問(wèn)題，包括進(jìn)一步明確向公告機(jī)構(gòu)提交申請(qǐng)的流程以及如何證明證書(shū)有效期的延期。”
“我們也在努力解決實(shí)際的執(zhí)行問(wèn)題，比如歐盟市場(chǎng)上罕見(jiàn)器械和小眾器械的可及性，”他補(bǔ)充道。“這個(gè)決定為幫助世界各地的患者向前邁出了堅(jiān)定的一步，AdvaMed將繼續(xù)支持穩(wěn)健的歐盟監(jiān)管計(jì)劃，用及時(shí)、可預(yù)測(cè)的方式促進(jìn)創(chuàng)新并改善患者獲取治療的機(jī)會(huì)。”
Gert Bos是RAPS的主席，Sabina Hoekstra-van den Bosch是RAPS的一名理事。RAPS是一個(gè)無(wú)黨派、非營(yíng)利的專業(yè)協(xié)會(huì)。他們的評(píng)論僅代表個(gè)人觀點(diǎn)。
© 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
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