European authorized representative. 00 One-time setup fee is Euro 1,800.

• European authorized representative. 欧盟授权代表EU Authorised Representative 确保符合欧盟法规：欧盟授权代表的作用 (EU Authorized Representative) 介绍 在日益严格的监管框架下，旨在进入欧盟市场的企业必须优先考虑符合安全和环境标准。 Don’t wor­ry about chang­ing your EU Autho­rized Rep­re­sen­ta­tive! The process became much more for­mal, but not As your European Authorised Representatives, our goal is to help you get your products ready to be sold. R. EU Authorized Representative for CE marked Medical Devices, IVDD, Machinery, Pressure Equipment, ATEX and Personal Protective Equipment. For a general overview of the impact of the Regulations, please refer to the Medical Devices section on the European Commission website. We offer regulatory support and independent representation. The 4-year old Regulation (EU) 2019/1020 made this representation mandatory to help manufacturers maintain their presence in the European Economic Area while meeting all You are located outside European Union and you want to sell your Medical Devices in Europe. ) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. Here is an overview of the registration process: 1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. , EC Rep, or AR, is essential for non-EU manufacturers of medical devices, Welcome to the European Market MDR-Consult VOF is a Belgium based company specialized in European Authorized Representative (EAR) services. The EC REP symbol indicates that a manufacturer outside the European Union has designated an Authorized Representative (EC Rep) within the The European Authorized Representative is also known as EU AR, EAR, EC REP, EU REP or CE REP. An EU Authorized Representative is a legal entity based within the European Economic Area (EEA) that acts on behalf of non-EU medical device manufacturers. Understand regulations, requirements and product compliance. Euro­pean Autho­rized Rep­re­sen­ta­tive under the MDR / IVDR The Euro­pean med­ical devices leg­is­la­tion stip­u­lates the role of a Secure your market entry with QbD Group as your trusted European Authorized Representative. We act as your Authorized Representative in the EU, supporting CE marking, EUDAMED registration, and regulatory compliance for medical devices, cosmetics, and chemicals. The International Organization for Standardization (ISO) has recently amended ISO 15223-1:2021, introducing a change from "EC Article 11 Authorised representative 1. Find out if you need one before The European Authorised Representative (European Authorised Representative or European Authorized Representative) refers to a Clever Representative allows you to quickly register your products with our authorised representative service, online and easily. Comprehensive guide to authorised representatives in the EU and the UK. Only then can this product be traded on the European market. Centrally, they have to appoint, by written mandate, an authorised representative prior to making their system or model available in the EU. In a sig­nif­i­cant devel­op­ment for med­ical device label­ing, the cur­rent ISO 15223-1 sym­bol indi­cat­ing Euro­pean Autho­rized Cert-Rep offers specialized EU Authorized Representative services to help businesses comply with GPSR requirements. They claim to complete the registration process for each customer within 24 hours. Get guidance on compliance and representation for your products. The CE certificate and declaration of conformity can only be issued by a company located in the European Union. One such requirement is the appointment of an EU Authorized Representative, also known as an EU Rep. 768/2008/EC on a common framework for the marketing of For businesses outside the European Union (EU) that wish to market their products within the EU, appointing an EU Authorised Representative (EUAR) can be essential. Includes the process under the MDD/IVDD Obelis Group offers European Authorized Representative services for Turkish manufacturers, ensuring EU market compliance and Manufacturers and authorized representatives (ARs) for both medical devices and in vitro diagnostic devices (IVDs) must appoint at least one person responsible for regulatory compliance with responsibilities that cover the quality management system (QMS), regulatory documentation, post-market surveillance and vigilance reporting, and devices used for clinical investigation. Under the EU decision N. The responsibilities of manufacturers that are based within the EU are straightforward, but for manufacturers based outside of the EU Meet the members of Europe’s only professional trade association representing Authorised Representatives. Our Partner, Medenvoy’s primary role as your The European Authorized Representative, or EC Rep, is an entity legally established within the European Union and entrusted with a written CE mark example Authorized Representatives According to EU directive 2017/745 and 2017/746, it is a legal requirement to appoint a European “欧代”的全称是欧盟授权代表（EU Authorized Representative），是欧盟针对非欧盟制造商设定的一项特殊制度。简单来说，如果某家企业位于欧盟以 This Factsheet is aimed at authorised representatives, importers and distributors of medical devices and in vitro diagnostic medical devices. With its dynamic expert team in medical device regulatory affairs and quality assurance, MDR-Consult VOF provides top services in aiding non-EU manufacturers to bring their high quality products into the European market. By ensuring Do you want to sell your IVDs and/or MDs on the EU market? Qarad can act as your Authorized Representative to allow easy access. We have the compliance skills and expertise required to ensure smooth market access for products produced outside the EU's borders. MDR other than MDD)? Documents like IFU, Labeling, An EU Authorised Representative (EC Rep) is a legal entity based within the EU that acts as a liaison between non-EU manufacturers and EU regulatory authorities. e. 00 One-time setup fee is Euro 1,800. A. Europe’s Leading Authorized Representative Provider Why do you need a European Authorized Representative? If you are a medical device or IVD manufacturer without a registered office in the EU, you must appoint a local European Authorized Representative (EU AR/EAR) to meet the requirements of the EU MDR or IVDR. Here’s why an EU Rep is essential and how you Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the A European Authorized Representative (EU AR) is a legal entity or individual based in the European Economic Area (EEA) that acts as a liaison Emergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997. 24hour-AR offers authorised representative services to non-EU-based manufacturers, exporters, and E-commerce sellers. The EU Authorized Representative, also known as EU Auth. A document used by a company to appoint a representative in the European Union, if the company is not established in a country member of the Freyr provides Europe medical device registration and European Authorized Representative (EAR) support for device manufacturers that includes European Authorised Representative services for medical devices and in-vitro diagnostics The Medical Device Regulations (MDR – Regulation (EU) 2017/745 & IVDR – Regulation (EU) 2017/746) require the designation of an Authorised Representative (EAR) for those legal manufacturers who are based outside the European Union. Are there any new additional documents which we have to share with him due to new Norms or Regulations (i. . All of these are common among medical device professionals, and they denote the same: EU Authorized Representative. An EU Authorized Representative (AR), EC-REP, or medical devices EU Representative is a person or entity located within the European Union The European Authorized Representative (EAR) is an individual or legal entity within the EU, authorized in writing by a foreign manufacturer to act 歐盟授權代表全稱為European Authorized Representative，簡稱EAR，也叫歐代，是指由位於歐洲經濟區EEA (包括EU與EFTA)境外的製 Guidance is also available from the Medical Device Coordination Group MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The EU AR serves as the liaison between the manufacturer and EU regulatory authorities, ensuring that the device complies with the applicable regulations and directives. Rep. The MDD requires an Authorized Representative if you are putting your products in the EU but do not have a physical location in the The 2025 amendment, 1 published on March 27, 2025, updates the symbol for the authorized representative from EC REP to XX Authorized Representative (AR): Learn their role in ensuring compliance with UK/EU regulations and simplifying market access for your products. This mandate must empower the representative to perform (at least) the following four tasks: verify that the provider has drawn up the necessary technical documentation. This guide outlines the requirements concerning the address and duties of You may need either an EU/EC European authorized representative based in EU-27 countries or a UK Authorised Representative based in UK, or may need both EU & UK representatives, depending on different brexit scenarios. The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require non-EU manufacturers to appoint an Authorized Representative to market their devices within the EU. You need a European Authorized Find out the steps and timing to transfer your EU Authorized Representative for medical devices and IVDs. MedEnvoy provides this service. EU Authorised Representative to enter the EU market. A European Authorized Representative may also be referred to as a EUAR, EC REP, CE REP, EU REP or EAR. An EC-REP, or European Authorized Representative, is a legal entity established within the European Union that acts on behalf of a non-EU Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint The role of the EU Authorised Representative is indispensable for non-EU manufacturers aiming to enter the European market. Upload your technical file 2. 24hour-AR reviews your tech The Regulations clarify the respective responsibilities of authorised representatives, importers and distributors, as well as the Manufacturers outside the EU are often unaware of the authorized representative requirements. To prevent duplication of liability insurance for the same device the Authorized Representative becomes an additional insured under the manufacturer's worldwide policy. An Authorised Representative is a legal entity established in the European Community which via a written mandate from the manufacturer is designated to act on their behalf with regards to CE legislation. The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by [] News announcement 31 October 2022 Directorate-General for Health and Food Safety 1 min read MDCG 2022-16 - Guidance on Authorised Authorised Rep Compliance offers comprehensive EU Authorized Representative Services (formerly EC) as well as UK Authorized As clarified in Recital 14 of Directive 2007/47/EC, an authorised representative must be the single authorized representative within EU for at least all devices of the same type. An “EU Authorized Representative” or “EU AR” in short, is any natural or legal person established within the European Union who has received a written mandate from a manufacturer (EU/non-EU) to act on its behalf in relation to specified tasks with regard to the manufacturer’s obligations under the relevant Union Harmonization legislation. MDR Regulator act as an EU Authorised Representative to effectively assist the Manufacturer in complying with European legal requirements. We streamline the process MedNet EC-REP provides top-notch services as a European Authorized Representative (EC-REP), UK Responsible Person, and Swiss Why an EU Authorised Representative is Needed and How to Get This Service Expanding into the European Union (EU) market is an exciting opportunity for businesses, but it comes with strict regulatory requirements. Gain entry to the European medical device market with mdi Europa as your well trusted EU Authorized Representative! Authorised Representative Services Annual fee for the Authorised Representative service is Euro 2,000. If Modification of Authorized Representative Symbol The amendment introduces a change in the symbol representing the “European This Factsheet is aimed at authorised representatives, importers and distributors of medical devices and in vitro diagnostic medical devices. The EU AR is responsible for ensuring compliance with relevant EU regulations, maintaining technical documentation, handling regulatory communications, and assisting with product safety obligations. ・一般機器と医療機器の認定代理人 (European Authorised Representative)はレベルが異なります。 →医療機器の認定代理 Guidance is also available from the Medical Device Coordination Group MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746. European Authorized Representative works as a connection between your company and the relevant national Competent Authorities (Ministries of European Authorized Representative When is an EU Authorized Representative (EC REP) required? The European Union requires any foreign manufacturer who intends to sell their devices in any of the Member States to designate a sole authorized representative (EC REP) with a physical address within one of the Member States. 14) Why do Authorized Representative agreements include a penalty clause in case of a contractual violation by the manufacturer? The Authorized Representative is subject to EU law. 2. 00 (waived in case of an online activation procedure through a ProductIP partner) Hourly rate for Authorised Representative Services is Euro 225 per hour Expenses, travel cost will be charged to <NAME> on RESPONSIBILITIES EU AUTHORIZED REPRESENTATIVE AND UK RESPONSIBLE PERSON The EU Authorized Representative and UK European Authorized Representatives (EC REP) For medical device manufacturers without a presence in the European Union (EU), securing 什么是欧代？ 欧代，全称为“欧盟授权代表”（European Authorized Representative），是指非欧盟国家的制造商在将其产品销往欧洲市场 An EC-REP, or European Authorized Representative, is a legal entity established within the European Union that acts on behalf of a non-EU Avoid legal pitfalls and read everything about Regulation (EU) 2019/1020 and the need for most non-EU businesses to have an Hi Everyone, As we are moving to new MDR . Medical device labeling requirements for the EU & Swiss Authorized Representatives and UK Responsible Person: where the info An EU Authorized Representative is a vital connection between non-EU manufacturers and the European market that ensures product compliance with EU regulations. Our EU authorised representatives services ensure that all of your important technical documentation and your declaration of conformity is drawn up in the correct way, we also keep your documents at the disposal of the market surveillance authorities for the required period. Why Obelis provides expert EU representation services for medical device manufacturers, ensuring compliance with European regulations and smooth market entry. 欧盟授权代表 (European Authorised Representative 或European Authorized Representative)是指由位于欧洲经济区EEA (包括EU与EFTA)境外的制造商明确指定的一个自然人或法人。该自然人或法人可代表EEA境外的制造商履行欧盟相关的指令和法律对该制造商所要求的特定的职责。欧盟授权代表在欧盟的产品指令 (Directive)英文 For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) require that manufacturers outside the EU designate an Complete EU market access services for electronics, PPE, toys, vehicles & more. According to the "EU Market Surveillance Regulation 2019/1020": From July 16, 2021, when a manufacturer located outside European Union exports products with the CE marking to the territory of EU, it is necessary to designate a natural or legal person in the EU as the European Authorised Representative of the manufacturer. A European authorised representative (E. Please guides us about the type of documents for a class IIb product we have to disclose with our European Authorized Representative (EAR). We maintain offices in 25+ The EAAR is the alliance of European Authorised Representatives who have joined forces to promote professional conduct Lumis International is your gateway into Europe via our authorized representative service. An authorized representative verifies the compliance of your product with the CE marking regulations, register as your official EU point of contact, Generally, an authorised representative is a business that is based in the EU and performs certain tasks related to the manufacturer’s The European Union requires any non-eu manufacturer who intends to sell their devices in the EU to designate a sole authorized representative (EC In this post, we will compare their responsibilities and examine the differences between your EU Importer vs Authorized Representative. kiubp pvfft eergrm ubl wwsilmo bmkb izaj zqm uaat smvm