Why do I need an authorized representative? Medical device manufacturers based outside the EU must have an authorised representative to sell their products within the European Union. This applies to manufacturers of all medical devices (divided into four main categories according to the EU MDR 2017/745): 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. 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. 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). 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. Do you have any other questions about ARs for medical devices or about changing the guidelines due to the new MDR and/or Brexit? Certification Experts is ready to help you.
What does an authorized representative do? An authorised representative verifies that products sold on the EU market comply with established European safety requirements. An AR does not certify products, but verifies the documentation provided by the manufacturer and evaluates the certification procedures and product safety. You can perform the following steps on behalf of the manufacturer: 4) Are authorized independent medical devices sold in Europe? 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)). 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. 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. You need to 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. 15) If we terminate our agent contract, will all obligations cease immediately? 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`. 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.
There are national laws in each Member State and someone should implement them. It is important that it is clearly described in the agreement. You still are not done after signing the agreement. As mentioned earlier, you will then need to start working on your labeling material and perhaps create promotional material. But all the steps of registration with the responsible authorities are also important. In both cases, the manufacturer must appoint a new authorised representative within the EU in order to continue selling products on the European market. 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.
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. First of all, this change must appear in the agreement between the manufacturer and the authorised representative (outgoing and incoming). 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. 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. 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.
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 para. 2 of the Medical Devices Directive; `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.` First of all, the European Representative must carry out the tasks that you have defined in the agreement in accordance with the agreement. .
