我们的IVDR咨询服务确保您的体外诊断设备符合最严格的欧盟标准IVDR 2017/746。
IVDR的技术文档是必不可少的一部分，因为它包含有关体外诊断医疗设备(IVD)的信息的汇编。
它必须在整个产品生命周期中得到维护。在向欧洲市场引入体外诊断医疗器械时，制造商必须确保遵守体外诊断医疗器械(IVDR)法规(EU) 2017/746中概述的所有适用法规。
根据器械分类和选择的符合性评估方法，公告机构可能需要评估技术文档的一个或多个部分。
提交技术文件的指南符合体外诊断医疗器械(IVDR)法规的标准，详见法规(EU) 2017/746法规附则II和III。
CMC将根据新的IVDR 2017/746法规指导您完成体外诊断设备在CE认证中的各个步骤，直至为您的设备加贴CE标志。
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.
