In the event that the manufacturer does not comply with Article 10, the authorised representative shall be liable for the defective equipment at the same level as the manufacturer. The obligations of authorised representatives shall include at least verification that the EU declaration of conformity and the technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure (Article 11(3)(a) DSR/IVDR). A representative must also keep copies of all available documents and make them accessible to the authorities upon request. This includes technical documentation, declarations of conformity and certificates, including amendments and additions thereto (Article 11(3)(b) of the RDM/IVDR). 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. The Regulation also describes the tasks that the manufacturer may delegate to the authorised representative and the conditions under which this may be done. This relationship should be the subject of a specific mandate. 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. An authorised representative shall cooperate with the authorities with regard to preventive and corrective measures and shall immediately inform the manufacturer of complaints and official requests for samples. 14) Why do authorized representative agreements contain a penalty clause in case of breach of contract by the manufacturer? Article 14(2) of the Medical Devices Directive states: `Where a manufacturer who places a product on the market in his own name does not have an establishment registered in a Member State, he shall appoint a single authorised representative in the European Union.` If you look at Article 11 of Regulation 2017/746, you can see that the main requirements are similar. There are some differences in terms of device specificity. For manufacturers of medical devices that can be described in detail by the above, it is therefore required by law to appoint a European representative. Your European Authorised Representative (EC REPRESENTATIVE) provides a point of contact between you (the non-European manufacturer of medical devices), the competent national authorities (Ministry of Health) and the notified bodies. Whether a medical device requires a notified body (in the case of sterile/measuring/reusable Class I or IIa, IIb, III) to obtain the CE marking, or whether it is allowed to declare itself (class I non-sterile, non-measuring), manufacturers established outside the EU are required by law to appoint an authorised representative so that their products can circulate legally on the EU market. An authorised representative is defined as any natural or legal person established in the European Union who has received and accepted a written mandate from a manufacturer established outside the EU to act on behalf of the manufacturer in relation to certain tasks related to its obligations under the Regulations.
12) What are the obligations and responsibilities of the authorised representative if the manufacturer`s products do not comply? According to the Medical Devices Regulation, this authorised representative must be permanently and permanently available, qualified and have the necessary expertise in the regulatory requirements applicable to medical devices in the EU. Specifically, your authorized representative should have specifically identified a Regulatory Compliance Officer (CRPP) in their organization. A reseller, importer or EU address without a qualified specialist is no longer enough. The authorised representative should terminate the mandate if the manufacturer fails to fulfil his obligations (Article 11(3)(h) of the RDM/IVDR). In such cases, the authorised representative shall immediately inform the Member State in which he is established and, where appropriate, the notified body involved in the conformity assessment of the product of the termination and the reasons for it. So, if you have many generic device groups, you can select many authorized representatives. In addition, authorised representatives must verify that the manufacturer has registered the information requested in EUDAMED (Article 11(3)(c) of the MDR/IVDR). 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.
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. The EU representative is subject to EU law. However, the manufacturer of the device is domiciled outside the jurisdiction of the EU and may decide not to cooperate with the EU authorities. In order to minimise the risk that the authorised representative is on the receiving side of a manufacturer`s responsibilities, penalty clauses provide a remedy. 4) Are independent authorised medical devices sold in Europe? CE certification only allows penetration of the European market and not other global markets such as the Middle East and African countries. Due to the high standards and popularity of CE marked medical devices, non-EU countries require a certificate of free sale from the manufacturer to prove that the medical device meets the private label requirements. Both the EU representative and the manufacturer are obliged to put an end to the infringement under the conditions imposed by the Member State, such as recalls, sanctions, sales bans, etc. In addition, the manufacturer places its name on the device. Step 2- After signing the contract, the manufacturer submits the necessary documentation in accordance with a checklist provided by EUROPECERT. For defective products, the authorised representative is liable with the manufacturer if the manufacturer has not fulfilled his obligations under the regulations and is not based in the EU (MDR/IVDR Article 11(5)).
The regulations also describe activities which cannot be delegated to an authorised representative and which may not form part of the mandate between a manufacturer and an authorised representative (Article 11(4) of the RDM/IVDR). These include, for example, requirements relating to product design, quality management system or preparation of technical documentation; it is the sole responsibility of the manufacturer. 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. In accordance with the European Medical Devices Directive and the Medical Devices Regulation, a European representative must be appointed by a foreign manufacturer (European Community) of in vitro diagnostic medical devices. The authorised representative should have permanent and continuous access to a person responsible for compliance (Article 15(6) of the MDR/IVDR). According to the new MDR (EU) 2017/745, Authorized Representatives (EC Rep) have greater responsibility and assume much more risk and responsibility, so you can expect your representative to review your documents more thoroughly. For more information on MDR or IVDR `click here`.
Each class of medical devices 3500 Euro / TWO UMDNS or product code GMDN. Additional Medical Devices 200 Euro / Product Codes Podcast Episode 7 Website: podcast.easymedicaldevice.com/7 You should understand this as a category of similar products. If you sell wheelchairs, all wheelchairs are part of a generic group. But if you sell pacemakers and orthopedic implants, these are 2 different generic devices. First, you choose an authorized representative who is experienced and experienced in the fields of medical devices and who has knowledge of technical documentation and design records. You will then draft an agreement in which the essential obligations of the authorised representative in accordance with the requirements of the Medical Devices Directive or the Medical Devices Regulation are clearly defined. A change of authorised representative requires an appropriate agreement defining the arrangements between the manufacturer and the outgoing representative and the new authorised representative (Article 12 of the RDM/IVDR). I`m sure I`ve forgotten other tips, but if you stick to them, there`s no reason to make a mistake. Now you will ask me which is the best model for you.
Below is a diagram of it. The competent authorities may request that it submit it for review as soon as possible, but as it is not a professional regulatory authority, the keeping of records and the review of the amendment of these documents may be problematic. There is the first step where you are looking for the right one. .