Medical device or IVD manufacturers without a registered office in their chosen market must designate a local Representative (e.g. an Authorised Representative in the EU). MedQAIR is working to become a reputable local representative for the medical device, in-vitro medical device, and AI industry to fulfil the position and obligation of authorised representatives for
We are also striving to expand our local representative specialisation across other countries to be able to represent you on a global scale. We take over the role and responsibility of your authorised representative to help you with organisational establishment in the respective jurisdiction.
Our extensive industry competence and knowledge of a multitude of medical devices, including high-risk devices, allows us to be your reliable medical device regulation and Artificial Intelligence regulation partner for ensuring compliance with the MDR, IVDR, and the Artificial Intelligence Act.
We have a network of regulatory experts internally, or externally and have compliance guidance experts with years of industry experience. We help you achieve country-specific medical device compliance and Artificial Intelligence compliance across diverse domains of medical devices, IVDs, and AI-based systems and devices.
If you already have a European Authorised Representative, it can still be worth switching. Pricing across the market differs and we would be happy to provide you with a quote for our authorised representative services.
Our specific expertise on high-risk medical devices, software medical devices, and software medical devices using Artificial Intelligence, allows us to support you with any specific needs you may have as your Medical Device Authorised Representative.
Did you know that appointing an Authorised Representative may also be required as part of the Artificial Intelligence Act in the European Union? If you embed Artificial Intelligence within your medical devices, the Authorised Representative should understand the risks associated with its use. Always ensure that you choose an Authorised Representative who understands your products.
Partnering with MedQAIR as your local representative in Europe can eliminate your regulation hassles without escalating challenges along with a quicker pace of progress. Being a leading medical device representative, our holistic regulatory expertise (EAR, UKRP, and CH-REP) can support you in creating approval-ready submissions in days rather than months. Our support will help you establish compliance for your medical devices, IVDs, AI-based medical devices, and for your physical EU market presence in accordance with specific compliance mandates. Appoint us as your local representative in the EU and achieve compliance for your registered products.
An EU AR is defined as any natural or legal person based in the European Union who has received and accepted a written mandate from a manufacturer located outside the EU to act as a medical device representative on the manufacturer’s behalf about specific tasks relating to the latter’s obligations under the regulations.
According to Regulation (EU) 2019/1020, companies without a physical presence or address in the EU that sell products to EU consumers must have an AR as their local representative. It differs based on your chosen market/target country/respective union. In Europe, it is EU Authorised Representative (EAR), UK Responsible Person (UKRP) in the United Kingdom, and Swiss Authorised Representative (CH-REP) in Switzerland.
The EU AR will be your local representative representing your company before the national authorities as per the EU Medical Device Regulation (EU MDR 2017/745), the European In Vitro Diagnostic Regulation (EU IVDR 2017/746), and the Artificial Intelligence Act (EU AI Act). Prior to commercialization, they will register your devices in the electronic system to serve as a liaison between a manufacturer and a national competent authority. All product-related labelling includes the use of a registered address and name.
Choose any natural or legal person residing in the EU willing/able to function in this capacity and execute a legally binding agreement designating themselves as your EU AR for complying with EU medical device regulations and Artificial Intelligence regulations.
Yes, the name and address of an EU Authorised Representative must be listed on the device label. This should be shown across the product label, outer packaging and/or Instructions for Use. It should be shown next to the official EC REP logo.
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