As per the data of theUK government, UKCA mark requirements for medical devices are based on the 3 main types of medical devices and their associated Parts in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002):

• 一般医疗设备：英国MDR 2002的第二部分
• 有源植入医疗设备：英国MDR 2002的第三部分
• 体外诊断医疗器械（IVDS）：2002年英国MDR的第IV部分

您需要证明您的医疗设备通过执行符合性评估来满足英国MDR 2002中的要求。评估路由取决于设备的分类。您可以在您的产品上放置UKCA标记，以显示医疗设备已通过符合性评估时满足要求。A UKCA mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002. To be placed in the Northern Ireland market the medical device should bear the UKCA mark accompanied by the CE mark.

豁免：如果，一个不应在产品上放置UKCA标记

• 这product is exclusively for clinical investigation and meets the requirement as far as possible.
• an in vitro diagnostic medical device (IVD) for performance evaluation
• 在特殊情况下使用的不合规装置（人道主义理由）
• Custom made device that meets the requirement in UKMDR 2002

很少的关键要求：

For UK medical device to be placed in GB market. From January 1, 2021, many changes were introduced, to how medical devices are placed in GB (England, Scotland, Wales) market:

• 包括IVD和定制设备在内的医疗设备应首先注册MHRA。
• A new product marking i.e UKCA is available for the product to be placed in Great Britain
• If a manufacturer is outside the UK, he needs to appoint a single UK responsible person who can carry out a task such as registration on behalf of the manufacturer.
• 直到六月30，2023年CE标志将继188bet金搏宝滚球续在英国公认。
• 到2013年6月30日certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market.
• 英国通知机构无法发行CE证书。

这ukca.标记requirement is based on EU legislation such as for active implantable devices EUAIMDD, for medical devices (EUMDD) In vitro diagnostic medical devices (EUIVDD)

MHRA医疗器械规则:

医疗和医疗保健监管机构负责the designation and monitoring of UK conformity assessment bodies. If a manufacturer is based in the UK and has the intention of supplying products in the GB market, they should be aware of the medical device regulation 2002 and general product safety regulation 2005.MHRA does not give any certificate, accreditation or approval for the device. As per the requirement of UKMDR 2002 manufacturer needs to inform MHRA before placing the device in the UK market.

谁可以注册MHRA？

I级，Classiia，IIB，III类设备，IVDS制造商，IVDS，IVDS制造商的制造商，如果制造商不是来自英国，则需要委任英国的单一负责人perform the task or complete the required things on the manufacturer’s behalf. Distributors and suppliers are not required to register with the 莫尔德。要注册MHRA，MHRA可能会要求您提供以下详细信息：

• 法律实体名称和地址
• Company type
• Administrative contact
• 课程的设备
• UDI-DI如果适用
• 医疗器械名称

这y may request further technical documentation as part of the scrutiny and data validation process. You can also referUK governmentwebsite for more info.

UKCA医疗器械法规和rules:

医疗设备制造商需要在1月1日之前使用Ukca标记，如果。该产品适用于英国（英格兰，苏格兰，威尔士）市场。该产品需要第三方符合性评估。这Product is covered by legislation that requires the UKCA marking.ukca.s technical requirements, conformity assessment process and standards to demonstrate conformity are largely the same as CE marking. The placing of UKCA mark ids depends upon the product, UKCA marking can be applied on the product itself or packaging, in some cases, it may be placed in manuals it will vary as per the product.ukca.标记must be clear and visible,UKCA标记必须由制造商置于产品上。通过贴上UKCA标志，您可以全部责任该产品与所需立法。不应该有任何迹象或标记可能误解UKCA标记的含义。

很少有人记住：

Product registration with MHRA is a must, the medical devices to be placed in the UK market need to get registered with MHRA within the grace period. CE mark will be recognized till June 30,2023.如果您在英国以外，制造商需要指定英国负责人（UKRP）

If the device is CE certified the product /device can be placed in the UK market until June30,2023. There will be no need for rebelling在2013年6月30日之后，制造商将在其医疗器械产品上有一个UKCA标记，以便在英国市场上被置于英国市场，而对于NI（北爱尔兰）CE标记设备甚至可以在2023年6月30日之后放置。

Operon strategist is医疗器械咨询has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, CE marking and licensing you can connect with us.