The new European Medical Devices Regulation creates new tasks and liability risks for EU authorised representatives for medical devices.
MedTech companies are a key driver of innovation in the healthcare sector. Highly complex medical devices such as cardiac and brain pacemakers or high-resolution MRI/CT systems are indispensable in the everyday work of modern medicine. However, patients may be exposed to particular health risks due to the considerable complexity of such products. This can result not only in special legal liability risks for the doctors and clinics involved, but also for the manufacturers of the products and other economic agents. The new European Medical Devices Regulation ("MDR") particularly increases the liability risks for the EU authorised representatives (also known as "EU Authorised Representative" or "EC Rep") for medical devices, which is also relevant for its protection against liability risks.
What are medical devices?
Medical devices are products with a medical purpose that manufacturers produce for use in humans and that predominantly have physical effects. Unlike drugs, medical devices are not pharmacologically, metabolically and/or immunologically active.
The range of medical devices is very diverse and ranges from simple mouth spatulas or plasters to highly complex products such as heart and brain pacemakers, hip and knee prostheses, high-resolution MRI/CT systems, robot-assisted surgery, state-of-the-art irradiation devices for precision irradiation of tumours as well as big data/AI-supported diagnostic and treatment software.
Medical devices are divided into four main classes based on risk: I, IIa, IIb and III. The higher the risk potential for patients, the higher the class of medical devices and thus the requirement for market launch. In addition, certain medical devices may only be given to lay persons on the basis of a medical prescription or may only be used by medical personnel.
What are the new features of MDR?
MDR has been in force in all EU member states since 26/10/2021 to improve health and safety in connection with medical devices. MDR largely replaces the existing European and national regulations on medical devices.
Who are the EU authorised representatives and how are they different from the other economic agents?
Every manufacturer of a medical device that is not established in one of the EU member states must mandatorily appoint an EU authorised representative to be able to place a device on the market in the EU (cf. Art. 11 (1) MDR).
According to Art. 2 No. 32 MDR, an EU authorised representative is any natural or legal person established in the EU who has been commissioned in writing by a manufacturer established outside the EU to perform certain tasks on his behalf in the fulfilment of his obligations arising from the MDR.
However, the EU authorised representative is by no means a new agent in the Medical Devices Regulation. Compared to previous regulations, however, the obligations of the EU authorised representative in the MDR are now listed in detail. However, when medical devices are placed on the European market, the EU authorised representative is only one of the four economic agents that are standardised in the MDR. In addition to him, the MDR also defines the tasks and obligations of the manufacturer, the importer and the dealer.
Explanation: In contrast to the manufacturer that produces or processes the medical devices itself and markets them under its own name or the name of its own brand, the EU authorised representative takes on certain tasks for this manufacturer after a written order from the (non-EU) manufacturer. The MDR requires this to ensure that authorities can address a responsible person in the EU.
Unlike an EU authorised representative, a distributor is anyone in the supply chain who makes a medical device available on the market until it is put into service. This means that the dealer buys and sells medical products from an EU country.
On the other hand, a medical device importer places medical devices from a non-EU country directly on the EU market. As a rule, an importer buys a medical device from a non-EU manufacturer and then sells it to a dealer or directly to the final consumer. An importer has similar obligations to an EU authorised representative.
What is the EU authorised representative responsible for?
An EU authorised representative plays a decisive role especially in ensuring that a medical device complies with the legal requirements of the MDR. He is therefore obliged to check whether the manufacturer has prepared the required EU declaration of conformity (a formal confirmation that the medical device meets all requirements), the technical documentation and, if necessary, whether a corresponding conformity assessment procedure has been carried out, i.e. all the requirements for the safety and effectiveness of the medical device have been met in principle. Due to this central role of the EU authorised representative, the liability of the EU authorised representative in addition to the manufacturer's liability for the medical device and its safety is now provided for as a special novelty in the MDR.
In addition, the EU authorised representative must always keep a copy of the current technical documentation available and ensure that the medical devices and the manufacturer are registered in EUDAMED, a corresponding European register for medical devices.
The EU authorised representative also has an obligation to inform the manufacturer of user complaints.
The EU authorised representative is also the main contact person between the manufacturer and the competent national authorities. In addition to communicating with the competent national authorities, the EU authorised representative provides them with documents and samples of the relevant medical device on request and assists them in corrective and preventive actions.
Although the individual duties of the EU authorised representative are now standardised in detail in the MDR, they must also be specified in a written mandate contract between the EU authorised representative and the manufacturer.
What liability risks can exist for EU authorised representatives?
As a special innovation, MDR now expressly provides for liability of the EU authorised representative together with the manufacturer for defective products if the manufacturer fails to comply with its essential obligations under MDR (cf. Art. 11 para. 5 MDR ). An injured party can therefore initially only sue the EU authorised representative, for example because he is based in the EU unlike the manufacturer. A settlement with the manufacturer can then be made later (and vice versa). Corresponding liability is not stipulated for importers and distributors of medical devices in the MDR. This entails very comprehensive inspection and due diligence obligations as well as increased liability risks, especially for EU agents.
However, the specific liability risks for EU authorised representatives may vary greatly from case to case, mainly due to the wide range of medical devices. Therefore, various factors must be considered regularly in the context of a liability analysis and weighted individually on a case-by-case basis. Some relevant factors within such an individually determined liability matrix may include, for example, the medical use, the risk class, the approval status and the field of application of the specific medical device, the number and type of patients in which the product is to be used, the compliance history and business model of the manufacturer as well as the concrete content of the mandate contract between the EU authorised representative and the manufacturer.
Partnership with a liability insurance company specialised in these topics is required to counter these possible liability risks of an EU authorised representative effectively.
Conclusion
The new MDR creates a multitude of new tasks and liability risks, especially for EU authorised representatives. EU authorised representatives should therefore examine in detail the possible impact of these changes and, where appropriate, take the necessary measures to adequately cover any liability risks.
This requires an analysis of possible risks and corresponding protection on an individual basis. To ensure the best possible insurance coverage, we recommend detailed consultation with an insurer specialised in these matters.
