对于医疗器械和体外诊断设备，欧盟法规（MDR和IVDR）要求欧盟以外的制造商必须指定一名位于欧盟内的授权代表。该授权代表对确保这些设备的合规性至关重要，同时它将作为该制造商在欧盟内的主要联系人。
它是指由位于欧洲经济区以外的制造商明确指定的自然人或法人。自然人或法人可以代表欧洲经济区以外的制造商执行相关欧盟指令和法律要求的特定任务。
西班牙是欧洲联盟(EU)的成员，属于欧洲经济区(EEA)。
CMC Medical Devices & Drugs SL是欧盟授权代表协会(E.A.A.R)的成员。它拥有专业的监管团队，并有资格作为欧盟以外制造商的授权代表。CMC与有关部门保持着密切的沟通与合作，可以按照官方的指示为厂家执行相应的任务。
我们作为欧盟授权代表的职责
-
在适当时，于产品上市前向相关国家主管当局注册您的设备。
-
作为您与所有国家主管当局的主要联络点。
-
维护产品技术文件的副本更新，以供欧洲主管部门检查。
-
授权您在您的设备的标签、包装和使用说明上注明我们的名称和地址。
-
随时为您与国家主管部门之间的互动提供帮助。
-
负责与您和您的经销商合作，向主管部门报告事故和现场安全纠正措施(FSCA)。
-
保护文档的机密性。欧洲授权代表只能根据法律要求向主管当局出示技术文件。
-
监控法规的变化，并仅在适用时与您沟通。
-
在一个或多个成员国撤回医疗器械的情况下，代表您到欧盟委员会进行磋商。
-
维护与临床评估期间收集的所有数据的关键评估相关的报告，供主管部门审查。
-
通知或被主管部门通知严重设备事故或现场安全纠正措施(FSCA)。
-
上市后监测。
Frequently asked questions about TGA Registration
Manufacturers based outside the EU are legally obliged to appoint an Authorized Representative (EC REP) so that their products can legally circulate within the European Union market.
Regardless of whether a medical device requires the intervention of a Notified Body (in the case of Class I sterile/measuring/reusable, IIa, IIb and III) to obtain CE Marking, or whether the manufacturer can self-certify (Class I simple), those operating outside the EU must appoint an Authorized Representative so that their products can be placed on the European market.
The Authorized Representative plays a crucial role in ensuring device compliance, acting as the point of contact within the Union. The Authorized Representative’s minimum responsibilities include:
● Verifying that the technical documentation and other essential documents have been prepared and that the manufacturer has fulfilled its registration obligations.
● Providing the competent authority with all information and documentation necessary to demonstrate the conformity of a device.
● Transmit to the manufacturer any request from the competent authority to obtain samples of the device.
● Collaborate with the competent authorities in any preventive or corrective actions aimed at eliminating or mitigating risks that devices may present.
● Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about possible incidents related to a device for which they have been designated.
The European Authorized Representative (EC-REP or EAR) shares responsibility in case of defective products and is obliged to terminate the contract with the manufacturer if the manufacturer acts inconsistently with its obligations. Therefore, the EAR is responsible for defective products when the manufacturer has not fulfilled its obligations under the Medical Device Regulation (MDR).
Yes. Any manufacturer that is established outside the European Union is required to appoint an Authorized Representative (EC REP) based in the EU.
This requirement is essential for placing medical devices or IVDs on the market in accordance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
Without a designated EC REP, it is not legally possible to access the European market.
Not always. In some cases, an importer or distributor can be designated as the Authorized Representative, but this must be done formally and in full compliance with legal requirements.
However, this practice may lead to conflicts of interest.
Therefore, it is recommended to choose an independent EC REP with expertise in regulatory compliance.
Yes. The name and address of the Authorized Representative must appear on the product labeling, the outer packaging, or the Instructions for Use (IFU).
In addition, the official EC REP symbol, as specified in ISO 15223-1, must be included.
This information must be clear, visible, and legible to meet the requirements of the MDR and IVDR.
Yes. It is possible to change your Authorized Representative at any time.
The current and new EC REPs must coordinate the transfer of responsibilities to maintain regulatory compliance.
The manufacturer must also update the labeling, technical documentation, and EUDAMED records, if applicable.
For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) mandate that non-EU manufacturers appoint an authorized representative based in the EU. This representative is crucial for ensuring compliance and acts as a primary contact point within the EU.
Since 2014, CMC Medical Devices has been dedicated to providing representation and consultancy services to manufacturers seeking entry into the EU market. Our headquarters, located in Spain, places us strategically to work closely with EU institutions. We are actively involved in European Commission Working Groups and Horizon Europe, the EU’s research and innovation program, shaping the compliance landscape over the years.
CMC Medical Devices is also a member of the European Association of Authorised Representatives (EAAR) and a founding member of the European Responsible Person Association (ERPA), both organizations committed to maintaining high standards of service and professionalism.
We highly recommend choosing a professional representative for your company within the EU. CMC Medical Devices offers:
● A team of experts to guide you through the compliance process
● Confidential handling of all shared information
● No conflict of interest, as we do not engage in manufacturing or selling products
● Up-to-date information on regulatory changes
Since our establishment, CMC Medical Devices has grown significantly and is a reference company in Europe for regulatory compliance. Our experts are well-equipped to help you navigate the EU, UK, and Swiss markets.
Why appoint CMC Medical Devices as your TGA Sponsor?
Fast response
We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.
Efficient communication
Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.
Immediate support
We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.
Quick resolution
Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.
