CE_Drug Device Combination (DDCs)

药物磁盘组合（DDCS）产品是将医疗装置与药物和/或生物产品结合的治疗和诊断产品。由于这些声称是实现药物靶向的，因此被认为是对地方给药和个性化治疗的更安全，更有效的治疗方法。此类技术被称为患有严重疾病和疾病的患者，例如癌症，心脏病，多发性硬化症和糖尿病等。

Ex. Pre-filled syringe, Pen injector, Auto injector, Metered dose inhaler, Drug eluting stents, Catheter with antimicrobial coating, etc.

Drug-device combination products have also emerged as a new dynamic in medical product development, regulatory approval and corporate interaction demanding improvements in communications and coordination. Development of new combination products and assuring its timely and accurate market access involves defined pattern of interactions between manufacturers and regulatory agencies.

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CE drug-device combination

FDA清楚地定义了21 CFR 3.2（e）中的药物 - 源组合产品，而欧盟在其法律框架中没有单个定义。EU将组合产品视为药品或医疗设备。对于组合设备中的药物产品部分，评估是由欧洲药品局（EMA）进行的，而通知的机构确实对设备部分进行了评估。通知机构是欧盟委员会指定的组织，旨在评估医疗设备的合规性。

In response to multiple requests for advice on combination device quality requirements, EMA published “Draft guidelines on quality requirements for medical devices in combination products” which addressed the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a CE (Conformité Européenne) certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body (NB) on the conformity of the device.

This EMA guideline covers devices that are necessary for the administration, dosing or use of the drug. They can be integral, co-packaged or referred to in the product information of the drug but obtained separately. It explains which information about the device needs to be submitted as part of the initial marketing authorisation application and subsequently during the product lifecycle. It additionally consists of a proposed template for the NB opinion on the conformity of the device to the relevant standard safety and overall performance conditions laid down in regulation (EU) 2017/745. It\’s intention meant that this guiding principle will increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and subsequently perfecting affected person protection. The regulatory framework for medical device incorporating medicinal substances as an ‘integral component’ is described in article 1(8) of MDR:

1. Where the action of the medicinal substance is ancillary, the product is regulated as a medical device and ought to be CE marked. As the action of the medicinal product is considered ancillary, a systematic opinion need to be provided from a medicines authority earlier than a notified body can issue a certificates for the combined product. Despite the fact that most of the people of digital developments are being driven and carried out inside the developed global, growing economies can be further left behind if they can not do development in regions so as to benefit them.
2. Where the action of the medicinal substance is main, the combination product is regulated under the medicinal products framework. In this situation, the relevant general safety and performance requirements (GSPR) of the MDR apply to the device component.

第1（9）条MDR中描述了管理设备的监管框架：

1. 如果管理设备作为单个积分产品的营销，专门用于给定组合中，并且不始终可重复使用，则该组合产品在药品框架下受到调节。在这种情况下，MDR的适用GSPR要求遵循设备部分。
2. 在所有其他情况下，管理设备均在医疗设备框架下进行监管。尽管医疗设备与医疗产品无关紧要，但该设备将需要标记。应该在药品指令下使用（单独的）药用产品。
3. 独一无二的sorts of drug- device combination product have distinct regulatory necessities. The type of combination and requirements are discussed in more detail as follows

Article 117 of the new European MDR amends annex i of the medicinal product directive (MPD) 2001/83/ec, point 12 of section 3. 2. This states that:

”(12),产品受这个指令,the marketing authorization dossier shall include, wherein available, the assessment of the evaluation of the conformity of the device element with the applicable general safety and overall performance necessities set out in annex i to that regulation contained inside the manufacturer’s European announcement of conformity or the relevant certificate issued by way of a notified body allowing the manufacturer to hitch a CE marking to the clinical device. If the dossier does not include the outcomes of the conformity evaluation cited inside the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is needed in accordance with regulation (ECU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the tool part with the applicable general safety and overall performance requirements set out in annex i to that regulation issued by a notified frame particular according with that regulation for the kind of device in query.”

Impact of MPD(medicinal product directive) on MAA(Marketing authorisation Application)

with the changes enforced by means of the EU MDR, the MAA should consist of either a:

• 通过NB发出的医疗设备组件的CE证书，或
• NBO（已通知的身体意见）对设备的一致性。

First option would require manufacturers of the medical devices to obtain CE marking with the aid of an applicable conformity assessment process applicable to the device. The CE certificate would then need to be submitted in the MAA to EMA.

如果未单独向设备组件发布CE标记的替代选项，制造商必须与NB联系并就设备的合规性寻求意见，并将MAA中的NBO报告提供给EMA。

The authority of final approval of the product will remain with the EMA.

This change in regulations substantially applies to those combination devices which are integrated, non-reusable and where the primary mode of action is because of drug element. Naturally, such devices are classified either as Class Is [sterile], Class IIa, Class IIb or Class III and intended exclusively for the stated combination. These needs to conform to the Annex I (MDR) GSPR and without the requirement to be regulated as a CE-medical device. Combination devices which are Class I(non-sterile) are not subject to an NB opinion.

How Manufacturers can apply Article 117?

• Identify a NB intending to be EU MDR designated for your precise technology
• Investigate which GSPRs are applicable to your products
• Obtain data that demonstrates conformance to the applicable GSPRs
• Assemble Technical Documents to aid the medical device components

One of the key challenges for drug-device combination devices are associated with addressing human factors studies and studies in representative user populations, particularly applicable to patient administered drug-device combinations. Important consideration needs to be given to the new requirements for post-market surveillance while preparing for operation.

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