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本周一（10月28日），欧盟委员会对其NANDO数据库进行了更新，将BSI Assurance UK Ltd纳入基于欧盟体外诊断医疗器械法规（IVDR）指定的第二家公告机构。
BSI表示，该公司是全球首个实现全范围指定的公告机构，涵盖IVDR框架内的所有器械，“其中包括几种具有特定特性而体外诊断医疗器械指令（IVDD，98/79/EC）所未涵盖的新类型器械，如癌症测试、基因测试、生理标记和伴随诊断”BSI在一份声明中提到。
继德国DEKRA之后，BSI成为另一家同时符合IVDR和MDR规定的指定公告机构。其他3家基于MDR实现指定的公告机构分别为：意大利的IMQ Istituto、德国的TÜV SÜD和德国的TÜV Rheinland。
但外界对公告机构能力方面的担忧情绪始终挥之不去。据MedTech Europe称，有11家拟在IVDR框架下实现指定的公告机构（MDR框架下40家）向欧盟委员会卫生与食品安全总司（DG SANTE）递交了完整申请，只有6家接受了现场检查。尽管如此，欧盟委员会仍预测，到2019年底同时基于IVDR和MDR实现指定的公告机构数量将达到20家左右。
欧盟医疗器械公告机构协会Team-NB表示，目前依照IVDD指定的公告机构有21家，但其中4家不会提出基于IVDR框架下的指定申请。还有3家并非基于IVDD指定的公告机构已经申请了基于IVDR的指定。
拒绝根据MDR和IVDR寻求指定申请的公告机构包括总部设在伦敦的英国劳氏质量认证有限公司（Lloyd's Register Quality Assurance, LRQA），该公司已于今年6月份根据欧盟现行指令退出了公告机构服务，并明确表示将不会申请基于MDR或IVDR的公告机构指定。此外，瑞士公告机构QS Zürich AG也决定不寻求MDR框架下的指定。
The European Commission on Monday updated its NANDO database to include BSI Assurance UK Ltd as the second notified body (NB) designated under the In Vitro Diagnostic Regulation (IVDR).
BSI said it is the first NB to achieve full scope designation, which covers all devices for IVDR. "This includes several new categories of devices with specific characteristics that were not covered by the In Vitro Diagnostics Directive [IVDD] such as cancer tests, genetic tests, physiological markers, and companion diagnostics," the company said in astatement.
BSI now joins Germany-based Dekra as the only NB designated under both IVDR and the Medical Devices Regulation (MDR). The other three NBs to be designated under MDR are: Italy-based IMQ Istituto, Germany-based TÜV SÜD and Germany-based TÜV Rheinland.
But NB capacity issues remain a lingering concern. According to MedTech Europe, 11 NBs under IVDR (compared to 40 under MDR) have sent completed applications to the EC’s DG Sante, and only six have had on-site inspections. But the commission is still forecasting about 20 NB designations for both IVDR and MDR by the end of 2019.
According to Team NB, 21 NBs are currently designated under the IVDD, but four of those designated under IVDD will not apply under IVDR, and three non-IVDD designated NBs have applied under IVDR.
Examples of NBs that have declined to seek designation under MDR and IVDR include London-based Lloyd's Register Quality Assurance (LRQA), which withdrew its NB services in June under the EU’s current directives and said it will not apply to be an NB under MDR or IVDR. Swiss NB QS Zürich AG also decided to not pursue designation under MDR.
来源：RAPS
原文链接：https://www.raps.org/news-and-articles/news-articles/2019/10/bsi-uk-becomes-second-nb-designated-under-ivdr
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