Medical Device Legal Representative
Advise many non-traditional life sciences and equipment manufacturers on the requirements and logistics of producing essential supplies. The distributor or importer who holds the equipment licence may be reluctant to authorize another distributor to market the product. Manufacturers usually re-register the device because distributors also do not issue certificates of no objection (NoC) for the transfer of the device`s license. Given all these scenarios, it is ideal for manufacturers to appoint independent companies with no business interests such as Freyr as their agent. A change of authorised representative requires an appropriate agreement defining the agreements between the manufacturer and the old and new authorised representative (Article 12 of the MDR/IVDR). The authorised representative should have permanent and continuous access to a person responsible for compliance (Article 15(6) of the MDR/IVDR). The requirements and responsibilities of an authorized medical device representative vary from one health authority to another. For example, the U.S. Representative for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) will serve as a link between the FDA and foreign entities that import or offer for import into the United States. The shared responsibilities of an agent include: Unlike our peers, we have a dedicated team of over 30 medical device experts, many of whom have worked for regulatory agencies and the private sector, with backgrounds in biostatistics, medicine, biomedical engineering, materials science, pharmacy and genetics. This is how we understand technology and can make better arguments for you. From launch and approval to product launch and maturity, we provide guidance that addresses the complex considerations where business and compliance meet. More than 2,000 companies worldwide retain full control over the registration of their devices by appointing Emergo as their independent professional representative.
Here`s why: Advising Vayu Global Health Innovations on obtaining an EUA from the FDA, which allowed its Bubble CPAP machine to be instantly distributed to hospitals to address the COVID-19 ventilator shortage. Assist several medical device customers in preparing distribution, import and power of attorney agreements that reflect EU MDR obligations. An authorised representative is defined as any natural or legal person established in the European Union who has received a written mandate from a manufacturer established outside the EU and has agreed to act on behalf of the manufacturer in relation to specific tasks related to his obligations under the Regulation. A manufacturer who is willing to market their medical device in a foreign market often needs to appoint a local authorized representative or a representative in the country if they do not have a registered office in the target country. The authorised representative is liable with the manufacturer for defective products if the manufacturer has not fulfilled his obligations under the regulation and is not established in the EU (Article 11(5) MDR/RDV). approved FDA reclassification of a new imaging device, tissue culture media products for ex vivo growth of human cells, and a variety of in vitro diagnostic test systems, eliminating the need for PMA approval. *According to a 2014 report by Battelle (research and development organization), growth is explosive in Georgia, Florida, South Carolina and North Carolina. Between 2007 and 2014, the number of medical device companies in these states grew by 64%, 48%, 40%, and 37%, respectively, compared to the national average of 12%. In addition, major medical device manufacturers are expanding their operations in the region to benefit from a lower cost of living and a high quality of life.
Tennessee`s concern for medical devices has increased by nearly 20 percent. In addition, more than 16% of the U.S. medical device industry, worth more than $35 billion, is located in the Southeast. An authorised representative for medical devices is any natural or legal person with a local establishment in the territory who is expressly designated by the manufacturer, acts on behalf of the manufacturer and may apply to the authorities and bodies of the country. Successfully helped IDx LLC obtain de novo reclassification by the FDA for the revolutionary AI-based IDx-DR device, which autonomously analyzes retinal images for signs of diabetic retinopathy. In order to enable foreign manufacturers to navigate regional regulatory requirements for registration, pre-certification and post-approval applications, Freyr acts as an agent on behalf of foreign manufacturers. The sponsor of a clinical trial – who is not established in the EU – must designate a natural or legal person within the EU as “legal representative”. As a full-service professional provider (with in-house medical and clinical expertise), we look forward to working for you as a “legal representative” within the meaning of Art. 50 MDR. We are responsible for ensuring that you comply with the obligations under the new Medical Devices Regulations (MDR).
Any communication through the “Legal Representative” is considered communication with you as a sponsor. If you`re based in the UK or selling equipment in the UK, we can help you prepare for a smooth transition to Brexit – find out more. In the highly regulated medical device industry, it is crucial for companies to have trusted legal advisors who can help them creatively implement their business strategies and in compliance with all rules and regulations. To bring a medical device to market, various issues must be addressed: from financing and patents to regulatory approval, manufacturing, distribution, etc. In many markets, your technical documentation, labels, manuals, and other information should include the name and address of your representative in the country. In other cases, your representative will be named on your registration certificate, giving them full control over the registration of your device in that market. Worked on pre-market submissions for IVDs in the areas of medical devices and biologics, as well as IND applications for imaging agents. Helping customers with new devices using AI and machine learning algorithms develop and align the FDA with creative regulatory strategies to bring these products to market quickly and efficiently. In most countries, medical device regulations require foreign manufacturers to appoint a representative in the country. Your representative acts as a liaison with regulators, helping you register the device and report adverse events. It is important to elect a representative who is familiar with the regulatory requirements of your product in order to act in the best interests of your company. Resellers or importers of devices may act as authorized representatives (ARs) of the manufacturer in the respective countries.
However, such a commitment presents difficulties if a need for several distributors or a change of existing distributor is identified. An authorised representative must cooperate with the authorities as regards preventive and corrective measures and inform the manufacturer without delay of complaints and requests from authorities concerning samples of products. In addition, authorised representatives must verify that the manufacturer has registered the requested information in EUDAMED (MDR/IVD Article 11(3)(c)). Baker Donelson`s medical practice is unique in that it incorporates experience rarely found in a law firm. Many of our lawyers have worked as executives of medical device companies at some point in their careers. We also worked directly with development engineers to document the design and development process, and helped manage civil criminal proceedings arising from equipment manufacturers` post-market activities, as well as many intermediate processes.