The Medical Devices Regulation (MDR) is a set of regulations for medical devices in the European Union (EU) to ensure safety, efficacy, and quality. Environmentally related requirements can also apply. Indeed, some strict obligations for device design and manufacturing mandate restricting, labeling, and tracking substances. The EU Database on Medical Devices (EUDAMED) and the Global Unique Device Identification Database (GUDID) are useful for this purpose.
The EU MDR was initially adopted by the EU in 2017 to improve the safety and efficacy of medical devices distributed within the EU. This replaced the 1993 Medical Devices Directive and its amendments. MDR has since been amended by Regulation 2020/561. Moreover, this medical device regulation is a component of the European CE marking requirements, along with other environmental requirements like the EU eco-design and RoHS directives.
The MDR sets out new rules for the design, manufacture, and marketing of medical devices, as well as requirements for clinical investigations and post-market surveillance. For example, the MDR requires manufacturers to perform clinical evaluations to demonstrate the safety and performance of their devices before they can be placed on the market. The MDR aims to ensure that medical devices placed on the market are safe, effective, and of high quality while promoting innovation in the medical device industry.
Additionally, the MDR places strict requirements on the design and manufacture of medical devices. Specifically, devices must be designed and manufactured to minimize risks from substances or particles that may be released from the device.
For instance, a medical device manufacturer must ensure that their implantable medical devices are designed to minimize wear debris, degradation products, and processing residues.
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Furthermore, the MDR restricts the use of certain substances in medical devices under certain conditions. Specifically, devices may only contain certain substances in concentrations above 0.1% w/w if justified. These substances include:
For example, a medical device that contains a restricted substance above the specified concentration without justification will not be allowed to be marketed in the EU.
In some cases, manufacturers may be able to justify the use of restricted substances in medical devices. To do so, they must provide:
For instance, a medical device manufacturer may be able to justify the use of a restricted substance such as lead in a detector-type device due to the absence of suitable alternatives. Likewise, the use of heavy metals such as lead, cadmium, and mercury are also exempted in infrared light detectors under the EU RoHS Exemption list for medical devices and monitoring and control instruments.
Phthalates are a type of substance that is commonly used in medical devices. However, they are also known to have endocrine-disrupting properties, which can be harmful to patients and users.
In fact, phthalates are regulated in some other European environmental regulations such as in EU RoHS and the EU REACH Substances of Very High Concern (SVHC) List.
To address the issue in medical devices, the European Commission mandates the relevant scientific committee to prepare guidelines for the benefit-risk assessment of the presence of phthalates, CMR, or endocrine-disrupting substances in medical devices.
Medical devices containing hazardous substances above 0.1% w/w must feature clear labels identifying these substances. Labels should be placed on the device itself, the unit packaging, or, where appropriate, the sales packaging. This requirement ensures patients and users are informed about the substances present in the devices, enabling them to make well-informed decisions.
If a medical device contains multiple declarable substances or lacks sufficient space for labeling, manufacturers can provide detailed information in the instructions for use (IFU) or the user guide. The IFU or the guide should include:
Furthermore, Annex II of EU MDR requires manufacturers to include information about the materials used in the device, including substances of concern, in the technical documentation. The justification for using hazardous substances must also be documented and subject to review by the Notified Body. Finally, manufacturers must upload technical documentation, including details about hazardous substances, to the EUDAMED database as outlined below.
Another method to inform the user is to use EUDAMED. It is an online database developed by the European Commission to support the implementation of the EU Medical Devices Regulation. EUDAMED is specific to medical devices marketed in the EU and contains information on medical device manufacturers, authorized representatives, and other economic operators involved in the supply chain, as well as details on the devices themselves. The database contains the following six modules:
This module allows manufacturers, authorized representatives, importers, distributors, and other economic operators involved in the supply chain of medical devices to register with EUDAMED and receive a single registration number (SRN).
This module contains information on medical devices, including their unique device identifiers (UDIs), device specifications, and labeling. Manufacturers are required to register their devices in this module before they can be placed on the market.
This module provides information on the notified bodies that have been designated to carry out conformity assessments under the EU MDR. It also contains information on the certificates issued by notified bodies, which demonstrate that a device complies with the regulation.
This module contains information on clinical investigations and performance studies carried out on medical devices in the European Union. Manufacturers are required to register their studies in this module.
This module allows competent authorities and manufacturers to report incidents and issues related to medical devices that have been placed on the market. It also contains information on the corrective actions taken by manufacturers in response to these issues.
This module provides information on the market surveillance activities carried out by competent authorities to ensure that medical devices placed on the market comply with the EU MDR.
Under EU MDR, manufacturers must upload specific documentation into the EUDAMED database via the modules specified above to ensure compliance, traceability, and transparency. The key types of documentation include:
1. Device Registration Information
2. Technical Documentation – As required under Annex II of EU MDR, this includes:
3. Declaration of Conformity (DoC) – A statement that the device meets the General Safety and Performance Requirements (GSPR) outlined in Annex I of EU MDR.
4. Post-Market Surveillance (PMS) Information
Post-market surveillance includes
manufacturers’ ongoing efforts, in collaboration with other economic operators, to establish and maintain a systematic process for proactively gathering and analyzing feedback on devices in the market. This process aims to identify and implement necessary corrective or preventive actions promptly.
5. Incident and Vigilance Reports – of serious incidents or field safety corrective actions (FSCA), as required under the vigilance system.
6. Certificates – issued by Notified Bodies, such as CE marking certificates, including scope, validity, and terms.
7. Clinical Investigation Reports – data from clinical investigations conducted to demonstrate safety and performance.
8. Economic Operator Information – details of the manufacturer, authorized representative, distributor, importer, or, if applicable, producer of the system or procedure pack (i.e., a set of products packaged together and sold for a specific medical purpose).
Compliance with the EU MDR is crucial for manufacturers who wish to distribute their medical devices in the EU since it is a mandatory regulation. Thus, non-compliance can result in significant penalties, including product recalls and even legal action. Therefore, manufacturers need to understand the key compliance obligations under the MDR and take the necessary steps to meet them.
GUDID, on the other hand, is a database developed by the U.S. Food and Drug Administration (FDA) to support the implementation of the Unique Device Identification (UDI) system in the United States. GUDID contains information on medical devices sold in the United States, including their UDIs, device specifications, and labeling. Manufacturers are required to submit information to GUDID as part of their compliance with the FDA’s UDI system.
Manufacturers must register their devices with the database and provide information on the device’s identification, classification, and substance composition. This information is then used to generate a unique device identifier that can be tracked throughout the device’s lifecycle.
The GUDID also provides a platform for healthcare providers to access information on medical devices, including:
This allows providers to make informed decisions about which devices to use and how to use them safely.
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