2020年5月22日 · In response to the Brexit, please be informed that since the 16th December 2019, Green DenTech’s CE notified body has been changed from SGS UK (CE0120) to SGS Belgium (CE1639). This change will NOT affect the Declarations of Conformities, but the labeling and certification.

A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states.

作为一家获得医疗器械指令 (93/42/eec) 认证资质的公告机构（英国为 0120，比利时为 1639），我们资质覆盖范围广泛，可帮助您获得 ce 标志认证。 该范围覆盖大部分产品，仅有一小部分例外，如有源植入器械。

2019年3月1日 · 有意向的客户可自愿申请转机构，将SGS UK NB 0120下的医疗器械CE证书转入NB 1639。 转机构流程即将公开，并有专门的客服人员提供针对性指导。 目前SGS在比利时及芬兰的业务持续顺利开展，公告机构SGS NB 0598和NB 1639均已在申请MDR资质，预计将于今年夏天取得授权。 其中NB 1639将扩大其授权范围与现有NB 0120一致，以此满足医疗器械及体外诊断医疗器械客户的认证需求。 随着计划的推进和政治形势的进一步明朗，SGS将提供进一步的 …

2017年6月6日 · CE 0120. Personal protective equipment with CE cat III protect you against potentially fatal risks. These are risks that can cause permanent injury or even death. This PPE protects you against very specific chemical or mechanical hazards.

2020年4月14日 · Following the end of the transition period, all CE Certified PPE products sold in to the EU, must bear the mark of a European-based Notified Body. We are now working to change the markings of our PPE products, to bear the Notified Body number 0598 (SGS Fimko), instead of 0120 (SGS UK Ltd.).

Class D devices must additionally have a Technical Documentation Assessment certificate (Annex IX section 4&5) before using CE 0120. The first step for you will be to determine your device(s) classification according to rules defined in Annex VII of the Regulation (EU) 2017/746.

2020年2月13日 · 英国主管当局MHRA已经确认，由英国公告机构 (SGS NB0120)发出的所有CE证书的有效期至少到2020年12月31日，前提是证书上的“有效期”是在2020年12月31日之后。 对现有欧盟授权代表的影响. 驻英国的欧盟授权代表在2020年12月31日之前仍将得到认可。 因此，如果您的欧盟授权代表在英国，且在2020年结束后仍计划继续在欧盟销售医疗设备，那么贵司必须找到一个新的位于欧盟27个成员国之一境内的欧盟授权代表。 如果您的授权代表在瑞士或土耳其， …

Complete lists of Notified Bodies for CE Marking Register/Notify your MDD -Medical Devices and IVDD -In Vitro Diagnostic Medical Devices in Europe by CE Marking

Learn about the relationship between MEDDEV guidance documents and CE marking for medical devices. Find out if compliance is required or optional.