药物 - 拆除组合（DDC）产品是therapeutic or diagnostic products that combine drugs, devices or biological products which leads to safe and effective treatments. It helps in targeted drug delivery, localized drug administration and individualized medicine therapy.With the advancement in technology drug-device combination products have developed a unique form of medicinal products that has cardiovascular, neurological, orthopaedic applications. The widely used DDC combination products are autoinjectors, inhalers,antibiotic-loaded bone cements, bioartificial liver devices,预先填充的雾化器，预先填充笔，预先填充注射器，透皮贴片等等。
This technology has introduced innovative and dynamic impact on the medicinal product and device development and also the regulatory approval. The very complex nature of the DDC combination products put forth the challenges not only to the manufacturers but also the regulatory agencies.
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In the US the drug-device combination products DDC are termed as combination products and the product is designated based on primary mode of action e.g single entity combination product with two or more regulated components, co-packaged combination products and cross-labelled combination products.
In the European Union (EU) the DDC products are treated as medicinal products or medical devices. The legal framework of either medicinal products or medical devices is applied with the primary mode of action governing the regulatory pathway. The agencies involved in the assessment includes EMA, the National Competent Authorities for the medicinal product part and the Notified Bodies 。
- Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-deviceCombination Products。
The European Medicines Agency (EMA) defines the combination products into three types: drug-Device组合产品，其中医疗设备与产品的一体，医疗器械与药品共同包装，以及用药品分别提供给使用者的药用设备。积分产品的实例包括单用预先填充注射器;单用预填充的笔和单用预先填充的注射器。用药品共同包装的医疗器械的例子包括口服给药装置勺子，自动注射器，可重复使用的钢笔等。
EUROPE’S MDR AND CE MARKING
欧洲药物局（EMA）提出了具有药物和医疗器械组件的组合产品制造商合规问题的指导。For drug-device combination products to be marketed in the European market it should undergo conformity assessment results or CE mark issued by notified bodies.For the devices that do not have CE marking the manufacturers need to submit conformity regarding components to MDR requirements from the notified bodies.
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第117条：CE标志为组合188bet金搏宝滚球产品
The EMA agency had planned to publish a draft guideline2019年6月，其中涵盖了包括装置组件或药物装置组合产品的组合药品的质量要求。该指南在MDR第117条中涉及。它建立了药物装置组合产品的新合规性要求。EMA已在2020年5月最终确定了这些指南，并从那时起，MDR已适用。
EMA AND ROLE OF NOTIFIED BODY UNDER ARTICLE 117
EMA各国that Article 117 of the MDR shall need involvement of Notified Body for the authorization of medicinal products that are integral medical devices and drug-device combinations to be in the European market. It applies to the medicinal products that are an integral part of the medical device where the action of the medicinal product is principal.
它落在第1（8）条第二项下，描述了用于管理医疗产品的医疗装置，即医疗器械条例第1（9）条第1（9）条的第二项所述，EMA）在问答文件中
Key elements addressed by the EMA Q&A
- The product’s device and medicinal component must form a single integral product and should not be reusable and the product should be used only in drug-device combination in order to fall under MDR Article 117.
- For the new applicants for marketing authorization CE mark will be required for device components of a drug -device combination product or the declaration of conformity must be granted which will determine the MDR requirement fulfilled by the components which are established in Annex I of the regulation.
新的欧盟MDR第117条ends Annex I of the Medicinal Product Directive (MPD) 2001/83/EC, point 12 of Section 3.2. This states that:
“（12）在哪里，产品受到该指令的管辖，营销授权档案应包括在可用的情况下包括设备部件的符合性的结果，并在附件I中列出的相关普通安全和性能要求that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
如果档案不包括第一个分段中提到的符合性评估的结果，如果可以单独使用的话，如果单独使用，则根据第2017/745的规例（欧盟）需要通知机构的参与，管理局应要求申请人对设备部分的符合性提供关于根据该规定的通知机构根据该规定为本的规定发布的条例所载的相关一般安全和绩效要求的意见有问题。“
- For the non CE mark products, the applicants must provide the conformity assessment opinions from notified bodies supporting MR annex I rules .
- The DDC products for sale in the European Union prior to May 26 2020 , will not be impacted by MDR Article 117 requirements.
制造商第117条的实施
步骤如下：
- Identifying a Notified Body (NB) which is EU MDR designated for the specific technology.
- The NB assesses and confirms the device’s relevant General Safety and性能要求（GSPR）合规性。
- Next step involves obtaining scientific data demonstrating the conformance to the applicable GSPRs.
- 最后组装技术文档以支持医疗器械组件。
Marketing of the DDC products requires manufacturers to seek a notified body opinion (NBO).预计NBO报告将由制造商提交给市场授权申请（MAA）的EMA。这将由主管当局评估，产品的最终批准将留在EMA中。
MDR第117第117条用于药物 - 装置组合产品的含义
将药品和医疗装置组合形成整体产品并受到欧盟Medical Device Regulation (MDR) 2017/745.The European Commission under the medical device regulation (MDR) has introduced article 117 which states the requirements for manufacturers for placing drug-device combination products into the market.
如果医疗设备的行动是校长，则在将其提交给MAA之前，适用于NB意见的通知机构营销授权应用。申请CE Mark.like medical devices, the manufacturers need to prepare a submission with the evidence of compliance of the device with GSP.