EU Authorised Representative
An EU Authorised Representative is required for non-EU medical device and IVD manufacturers who place CE-marked products on the market in the EU and other countries that recognise CE marking.
Our EU Authorised Representative Service
Patient Guard, with a registered office in Germany, offers EU Authorised Representative services for non-EU medical device and IVD manufacturers. This service enables companies without a registered business in an EU member state to secure market access within the European Union.
Benefits of working with Patient Guard
- Patient Guard ensures a simple and streamlined process.
- Patient Guard offers cost-effective services.
- Our team consists of highly qualified and experienced regulatory experts.
- Access the EU market with ease through Patient Guard.
- Rest assured your devices meet all regulatory requirements.
- Patient Guard is backed by professional indemnity insurance.
- Enjoy transparent pricing with no hidden fees.
- Add more devices throughout the year at no extra cost.
Why Choose Patient Guard as your EU Authorised Representative?
Patient Guard proudly serves as the EU Authorised Representative for over 30 medical device and IVD companies. These companies trust us to ensure their products comply with EU regulations and are properly registered.
We simplify the process, making it smooth and hassle-free. Our qualified and experienced team is equipped to handle any queries and Post Market Surveillance (PMS) activities, including vigilance, with speed and efficiency. We ensure seamless communication between manufacturers and relevant authorities, keeping everything running smoothly.
Our Process
- A signed mandate is established between Patient Guard and the manufacturer.
- Patient Guard reviews the medical device or IVD technical documentation to ensure compliance with the Medical Device Regulation (MDR) EU 2017/745 or the In Vitro Diagnostic Regulation (IVDR) EU 2017/746.
- Patient Guard requests the signed Medical Device or IVD Declaration of Conformity.
- If required, Patient Guard requests the CE certificate from a Notified Body for the medical device or IVD.
- Patient Guard registers the devices with BfArM, Germany’s competent authority, through the DIMID database.
- The manufacturer registers the devices in their EUDAMED account.
- Patient Guard accepts the manufacturer’s EUDAMED application through its EUDAMED account.
- Once completed, the manufacturer is authorized to sell products in the EU market.
Costs of Service
We offer a flat annual fee for our EU Authorised Representative service, with no hidden costs or surprise fees. Unlike many other providers, you can add unlimited medical devices or IVD products for registration throughout the year at no additional charge.
Getting started
Get in touch to learn more about our EU Authorised Representative service. We offer a free consultation where you can meet our team, discuss the process in detail, and share information about your company and products. After the consultation, we’ll provide you with a personalized quote and answer any questions you may have before you make a decision to proceed with our service.
EU Authorised Representative - FAQs
Once the mandate is signed and we receive the required documentation, we review it within one week and proceed with registering the products. The entire process typically takes less than two weeks from start to finish. In rare cases, the process may take longer if authorities have questions about the medical devices or IVDs, though this has not been an issue in our experience so far.
No, only medical device manufacturers (CE mark holders) without a registered business in an EU member state are required to appoint an EU Authorised Representative.
Yes, it is legally required to include the EU Authorised Representative’s address and contact information on the labeling of medical devices or IVDs.
The EU Authorised Representative conducts additional checks on medical devices manufactured outside the EU. They handle the registration of these devices with the competent authorities and act as the communication link between the manufacturer and authorities for Post Market Surveillance and Vigilance activities, especially in the event of any incidents related to the device on the market.
EU Authorised Representatives share joint liability for the medical devices they register and place on the market, making this a significant responsibility. This role includes handling administrative tasks throughout the year and managing any potential risks. Patient Guard also maintains high levels of indemnity and product liability insurance to ensure full protection.
Tracey Slater, Cormed
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