第 35 家“NB”机构的前世今生

今年的 11 月 29 日，欧盟的公告机构名单再次发生变化，增加了第35家公告机构。公告机构的机构编号为 No.1023，被授权旧指令的 IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)、MDD (Directive 93/42/EEC on Medical Devices) 和新法规的 MDR (REGULATION (EU) 2017/745 on medical devices)。这一家公告机构就是捷克的 ITC 公司，全称 INSTITUT PRO TESTOVÁNÍ A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION)。究竟 ITC 是何方神圣？今天我们就来扒一扒他的前世今生！

ITC 的前世

ITC 的成立可以追溯到 1969 年，当时在位于 VÚGPT Zlín（橡胶和塑料技术研究所）的国家实验室 SZ 224 开展活动。在革命后的年代，它以 SZÚCHP sho（国家化学工业测试研究所）的名称分离，并于 1991 年成立了现在的 ITC (INSTITUTE FOR TESTING AND CERTIFICATION) 公司。在1993年转型为股份制公司，业务范围扩大至检测、检测、认证、法医专家活动、管理体系等领域。

图1. ITC 公司 logo

ITC 的今生

ITC 最早在 2006 年以前就已经获得 MDD 和 IVDD 的授权，拥有超过 20 年以上的行业累积。

图2. ITC 公司在 2006 以前获得 MDD 授权

图3. ITC 在 2006 年以前获得 IVDD 授权

如今 ITC 业务遍布全球，在白俄罗斯、巴西、中国、埃及、克罗地亚、印度、伊朗、以色列、韩国、匈牙利、巴基斯坦、波兰，罗马尼亚、奥地利、俄罗斯、希腊、斯洛伐克、泰国和土耳其都设立了外国代表处。截至发稿时间，ITC 共计颁发了 36184 张证书，其中包括 IVD 的 CE 证书 2071 张， MD 的 CE 证书 4160 张，AIMD 的 CE 证书 50 张。

更是在今年的 11 月 29 日成功获得了欧盟新法规 MDR 的授权，正式成为 MDR 新法规下的第 35 家公告机构。

图4. ITC 在 2022 年11 月 29 日获得 MDR 授权

授权更新后，ITC 在医疗器械相关法规下的授权包含了 IVDD、MDD 和 MDR。

图5. ITC 法规授权列表

ITC 的 MDR codes 范围
MDA(13)
1	MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
2	MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
3	MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
4	MDA 0302 Active non-implantable devices utilising non-ionizing radiation
5	MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
6	MDA 0305 Active non-implantable devices for stimulation or inhibition
7	MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
8	MDA 0307 Active non-implantable respiratory devices
9	MDA 0309 Active non-implantable ophthalmologic devices
10	MDA 0312 Other active non-implantable surgical devices
11	MDA 0315 Software
12	MDA 0316 Medical gas supply systems and parts thereof
13	MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
MDN(14)
1	MDN 1102 Non-active osteo- and orthopaedic implants
2	MDN 1103 Non-active dental implants and dental materials
3	MDN 1104 Non-active soft tissue and other implants
4	MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
5	MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
6	MDN 1204 Non-active non-implantable devices for wound and skin care
7	MDN 1206 Non-active non-implantable ophthalmologic devices
8	MDN 1207 Non-active non-implantable diagnostic devices
9	MDN 1208 Non-active non-implantable instruments
10	MDN 1209 Non-active non-implantable dental materials
11	MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases
12	MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
13	MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
14	MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
MDS(10)
1	MDS 1001 Devices incorporating medicinal substances
2	MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)
3	MDS 1005 Devices in sterile condition
4	MDS 1006 Reusable surgical instruments
5	MDS 1007 Devices incorporating or consisting of nanomaterial
6	MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body
7	MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices
8	MDS 1010 Devices with a measuring function
9	MDS 1011 Devices in systems or procedure packs
10	MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
MDT(12)
1	MDT 2001 Devices manufactured using metal processing
2	MDT 2002 Devices manufactured using plastic processing
3	MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
4	MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
5	MDT 2005 Devices manufactured using biotechnology
6	MDT 2006 Devices manufactured using chemical processing
7	MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals
8	MDT 2008 Devices manufactured in clean rooms and associated controlled environments
9	MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
10	MDT 2010 Devices manufactured using electronic components including communication devices
11	MDT 2011 Devices which require packaging, including labelling
12	MDT 2012 Devices which require installation, refurbishment