وبلاگ خانه تبدیل شباهنگ مرکز تخصصی تبدیل صدا و تصویر
The biggest risk a manufacturer takes when applying the terms of the agreement with an AEOI in terms of liability and liability is the possible termination of the agreement. As required by Directive 2001/95/EC, a manufacturer established outside Europe may not place products on the European market without a representative established within the European Community. As a result, products deemed non-compliant in this way can expect withdrawals from the market or even a complete ban. 14) Why do authorized representative agreements contain a penalty clause in case of breach of contract by the manufacturer? What happens if we do not appoint an EC representative? Your notified body requires the appointment of an EC representative before issuing an EC certificate. Compliance with the MDR or IVDR is mandatory for any product placed on the EU market; Therefore, it is important to engage and identify the representative you are electing. If you do not appoint a representative, your products can be stopped at the border. Trustees assume more risks and responsibilities in accordance with the European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices (IVDR) Regulation. The EC EPR is jointly and severally liable for defective medical devices or IVDs, so you can expect your representative to monitor your compliance more thoroughly. Download our white paper to learn more about MDR`s changes. It is possible to designate a distributor as your authorized representative in Europe; however, it is not recommended as most traders are not willing to perform the mandatory tasks of the CE-REP. Instead, choose an independent representative who focuses on regulatory issues rather than sales and marketing. Learn more about the benefits of hiring an independent company as an EC representative in Europe.
In Europe, you are legally considered the main representative of the manufacturer. Thus, if the manufacturer acts fraudulently, you can be held responsible if you do not alert the competent authorities. Step 2- After signing the contract, the manufacturer submits the necessary documentation in accordance with a checklist provided by EUROPECERT. If I understand the interest of an authorised representative and the interest of a distributor, I would say that it is quite dangerous to appoint a distributor as your representative for the European Union. Your European authorised representative serves as a link between you and the competent national authorities (ministries of health). In addition, your designated representative: ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf If you already have one in Europe, you need to assess whether it is the right one. You`ll understand why in minutes. But if there is a conflict with your merchant about a fee increase or something else, it will cost you a lot of money to change all the labeling material. As stated in the Medical Devices Regulation, it is imperative that you appoint an authorised representative if you wish to sell your product in Europe. The authorized representative must not take the time to return this information to you. You can include it in writing in the agreement. The most important thing in choosing your authorized representative is to follow a simple procedure.
As you know, the name of the authorized representative appears on the product label. The distributor knows this and for him it is free advertising. Yes, according to MDD. The Medical Devices Directive requires that the manufacturer and the names of the authorised representative be printed on the device label so that both parties are held liable. In order to avoid double liability insurance for the same device, the agent is additionally insured under the manufacturer`s global policy. It can be really tempting to become an authorized representative of a company and offer the service. You may be an expert in medical devices and want to start your own business. Helping other companies grow their businesses can be a real challenge. No, the name of the authorized representative remains on devices already sold and still in use, which results in the maintenance of certain obligations even after the termination of the contract.
This is the European Association of Authorised Representatives for Medical Devices. Maybe they would help you answer other questions if you want to choose your European authorized representative. To put you on the right side, he must check that the classification you have identified is correct. This can be a challenge if you make a mistake. Please give me your comment. I am really curious to see if this topic was interesting to you and if there is one aspect that was missing. I promise to answer you. You need a person to comply with the legal regulations in this office. The aim is not only to have a European address, but also to fulfil all the tasks of an authorised representative. For manufacturers who are really new to EU regulations, it may also be important for your company`s authorized representative to assist you with CE marking in order to obtain CE certification and ISO certification.
So, this ability is really a “must”. What role does the signing authority play under the MDR and IVDR? Your distributor can also use this as an argument to pressure you to accept certain changes. It will start with a small fee increase. Then can go to a larger . But you`re stuck. This small increase will cost you less than completely changing all your labeling material. It will be your turnkey partner and should also treat some confidential information. This is a really interesting question.
And my answer is yes. Following the UK`s withdrawal from the European Union, equipment companies in the EU and third countries will have to appoint a UK Responsible Person (UKRP) who will continue to sell to the UK. In addition, UK-based companies need an EU-based AR to continue selling in the EU. Contact us to find out more about advisory services for the Brexit transition. At the same time, a qualified representative will define all the regulatory aspects and make the right decision, since he has no financial interest in selling more or less products. Although all of the above-mentioned obligations under Directive 2001/95/EC are the responsibility of the AEOI, it is important to note that the actual process of ensuring that all products are in full compliance with the Directive (and all other applicable EU Directives) is entirely up to the manufacturer and that any sanctions or effects of non-compliance are also the responsibility of the manufacturer. It is important to keep this in mind, as crossing the boundaries of the manufacturer`s AEOI relationship can lead to serious consequences. I`m sure I`ve forgotten other tips, but if you stick to them, there`s no reason to make a mistake.
۳) How do we choose between an agent, a distributor and an independent authorized representative? KPIs are also something that can help you negotiate the deal, the cost of the service. You expect a certain standard for the service you`re paying for, so try to have factual data that you can show and not just feel. To show more credibility, we recommend that you already have experience in the field of quality and regulation of medical devices. At least, if I am a manufacturer looking for such a partner, I would not opt for a beginner. For example, if your company is based in China and opens an office in Germany. .
