Seamless MDR Regulatory Compliance
As a seasoned EU Authorized Representative, MedQAIR ensures a smooth medical device regulatory (MDR) journey in the challenging EU regulatory landscape.
Stay Compliant With an MDR Regulatory Expert
The regulatory landscape for medical devices in the EU is constantly changing, posing ongoing compliance challenges for medical device (MD) and in-vitro diagnostics (IVD) device manufacturers. We offer comprehensive support for both hardware and software medical devices, including those powered by Artificial Intelligence (AI). Only a seasoned MDR regulatory specialist can help you confidently place and sustain your products in the EU market.
If you are a manufacturer of medical devices and/or in-vitro diagnostics and/or AI solutions without a physical presence in the EU, compliance with European Medical Device Regulations (EU MDR) mandates the appointment of a European Authorized Representative (EC Rep) situated within Europe. This representative serves as your intermediary with European regulatory authorities. The law also mandates the appointment of a Person Responsible for Regulatory Compliance (PRRC).
Need a competent Authorised Representative to assist you in adhering to EU Medical Device Regulations (MDR)?
How Does MedQAIR Empower Your MDR Regulatory Journey?
The goal of the MDR medical device regulatory framework is to ensure public health, safety, and market competitiveness. As per law, the MDR Regulator is an Authorised Representative. At MedQAIR, we possess the expertise and extensive experience necessary to serve as the Authorized Representative for non-EU medical device manufacturers. Additionally, we act as a PRRC for both EU and non-EU manufacturers.
As your Authorized Representative, we act on behalf of you, bearing responsibility for medical devices introduced into the European market. We serve as the recipient of obligations outlined in the European Medical Device Regulation (EU MDR). Additionally, we may conduct a conformity assessment of medical devices on behalf of the manufacturers. Our technical experts offer medical device regulatory consulting for every stage of the product lifecycle.
Want assurance that your product complies with regulations and will thrive in the European market?
MedQAIR as Your Trusted EC REP and MDR Regulatory Partner
- As a trusted Medical Device (MDR) Regulatory affairs partner in the EU, MedQAIR can serve as your independent EC REP and EU Importer.
- Play a crucial role in ensuring device compliance with EU regulations, serving as the primary point of contact.
- Ensure manufacturer compliance with EU regulations, including Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR).
- If you sell directly to customers or through e-commerce, use our EU address legally to access the European market.
- Handle all reporting, registration, and communication with European authorities and bodies, ensuring timely and accurate correspondence.
- Verify the preparation of your Declaration of Conformity and Technical Documentation, ensuring the selection of the appropriate conformity route.
- Verify that the manufacturer has fulfilled their EUDAMED registration obligations and pursued the suitable conformity route.
- Communicate with the competent authority regarding any adverse incidents or necessary corrective actions.
- Establish and maintain a legal agreement with the manufacturer, encompassing terms of payment, termination, duration, and the devices covered.
Are you a non-EU manufacturer seeking to place your CE-marked products on the EU market?
Frequently Asked Questions About MDR Regulatory
What is the European Union Medical Device Regulation (EU MDR)?
The European Union Medical Device Regulation (EU MDR) is a set of regulations governing the manufacturing, marketing, and distribution of medical devices within the EU. It aims to ensure the safety, effectiveness, and quality of medical devices while enhancing transparency and traceability throughout the supply chain.
The MDR replaces the previous Medical Device Directive (MDD) and introduces stricter requirements for manufacturers, including enhanced clinical evaluation and post-market surveillance obligations. It also strengthens the role of notified bodies and introduces new classifications for certain devices. Overall, the MDR aims to improve patient safety and ensure public health while promoting innovation in the medical device industry. The EU MDR became operative on May 26, 2021.
Why is complying with EU MDR crucial?
The EU Medical Device Regulation (MDR) is crucial because it replaces outdated legislation with regulations that better align with recent technological advancements and medical science. Creating a more transparent regulatory framework aims to enhance patient safety. Non-compliance with the MDR could result in costly fines, litigation, design modifications, product recalls, or even exclusion from the EU market.
If you are a Medical Device and/or IVD device manufacturer and your company lacks a physical presence within the EU, European medical device regulations require you to designate a European Authorized Representative (EC REP) based in Europe. This representative serves as your liaison with national competent authorities. This representation is mandatory for obtaining CE certification to sell your products in Europe.
Even if your company is already compliant with the Medical Devices Directive (MDD), it’s essential to ensure compliance with the new Medical Device Regulation (MDR) as it introduces significant changes and represents brand-new regulations.
What is the role of an EU Authorized Representative?
Apart from serving as a liaison between you and National Competent Authorities (Ministries of Health), your European Authorized Representative will:
- Assist with certain medical device and IVD registrations, as required.
- Be identified on your product labeling throughout Europe.
- Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request.
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors.
What are the liabilities of an EU REP?
If the manufacturer fails to comply with the general obligations outlined in MDR/IVDR Article 10 and does not delegate its responsibilities, the authorized representative assumes legal liability for defective devices on par with the manufacturer, jointly and severally. Consequently, the authorized representative can be held liable if:
- The manufacturer’s liability for a defective device is established under applicable Union or national law (e.g., Product Liability Directive 85/374/EEC transposed into national law).
- It is proven that the manufacturer has not fulfilled the general obligations outlined in MDR/IVDR Article 10.
Ultimately, liability would be determined by competent courts.
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