欧盟公告机构TÜV南德意志集团（TÜV SÜD）于上周四宣布，该机构针对德国Biotronik的其中一种III类（最高风险级别）医疗器械及其质量管理体系颁发了首张符合欧盟医疗器械法规（MDR）的CE证书。

一位发言人向Focus表示，这个新获得认证的器械为Biotronik公司的Renamic编程器软件，该软件能够让医生对植入式心脏器械进行编程和测试，如起搏器、植入式心律转复除颤器和心脏再同步治疗（CRT）系统。

Biotronik表示，在过去两年半的时间里，该公司一直致力于制定一项计划，旨在将其器械和质量管理体系向新的欧盟器械法律框架（即MDR）过渡，其中MDR将于2020年5月全面实施。

去年5月，总部位于德国的TÜV SÜD成为第二个被指定为MDR框架下的公告机构。此后又有另外两家公告机构获得指定，其中最近一家是在今年8月份指定的。

“自获得指定以来，TÜV SÜD一直在努力进行资源转移和筹备，以在新的法规框架下提供服务。“我们已经开始着手并将进一步说明公开问题，并在流程中实施新发布的MDR相关信息……当前所面临的挑战在于如何在现有的欧盟医疗器械指令（MDD，93/42/EEC）及有源植入性医疗器械指令（AIMDD，90/385/EEC）项目与过渡期间对MDR服务的强烈需求之间寻求平衡点”，担任TÜV SÜD产品服务部高级副总裁兼全球负责人的Royth von Hahn表示。

本月早些时候，英国BSI公告机构宣布Novartis Concept1吸入器成为首个获得MDR认证的器械，随后Biotronik公司的质量管理体系和III类器械也获得认证。

英文原文

First MDR Certificate Issued for Class III Device

Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system.

The newly certified device is Biotronik’s Renamic programmer software, which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy systems, a spokesperson told Focus.

Biotronik said that it’s been working over the last two and half years to develop a plan to transition its devices and quality management system into the new EU legal framework for devices, which will be fully implemented in May 2020.

Last May, Germany-based TÜV SÜD became the second notified body to be designated under MDR. Two other notified bodies have since been designated, with the most recent coming in August.

“Since receiving designation and notification, TÜV SÜD has been working hard on shifting and preparing resources to provide services under the new legislative framework. We have had and continue to clarify open questions and implement newly published information about the MDR into our processes…The challenge now lies in balancing our existing MDD and AIMDD projects with the strong demand for MDR services in this transition period,” said Royth von Hahn, SVP and global head of medical & health services at TÜV SÜD Product Service.

The certification of Biotronik’s quality management system and Class III device follows an announcement from BSI’s UK notified body earlier this month that the Novartis Concept1 inhaler is the first device to be certified under MDR.