Requirements for Distribution of Medical Devices in Europe
The European Medical Device Regulation (EU MDR) and the European In Vitro Diagnostic Regulation (IVDR) define distributors of medical devices as legal entities that provide medical devices to end users. Distributors of medical devices in the European market must comply with the various requirements in place.
1. Labeling Requirements
Distributors of medical devices on the EU market must adhere to the labeling requirements under the EUMDR and IVDR laws.
Labeling Requirements in Europe
Companies that distribute medical devices in the European market must provide more detailed, clear, and understandable labeling on their products. These requirements cover the names of the items, their dates of manufacture, authorized representative name, importer name, and additional details. The purpose of these regulations is to enhance safety in the use of medical devices.
Importance of Accurate Labeling
Various changes in the regulation specify new guidelines for the accurate labeling of medical devices. For example, ISO15223 provides guidelines to ensure everyone can access, read, and understand the labeling distributors put on their medical devices. Thus, distributors and manufacturers must provide labeling in legible fonts and in alternative formats to meet the needs of people living with disabilities.
Furthermore, regulation EN 1041 makes it mandatory for distributors of medical devices in Europe to provide labeling in two languages: local and English. The goal of this language requirement is to make it easy for everyone who uses medical devices to understand the labeling.
Examples of Labeling Requirements
Medical devices that distributors place on the European market must meet various labeling requirements. These requirements vary with the specific types of medical devices. For example, distributors must provide information about device identification, shelf life, and storage instructions for all devices. Device identification information includes the following details: name, type, model, and serial number.
Specific types or classes of medical devices need different types of labeling information. For example, Article 22 of the MDR specifies that distributors of medical devices that contain medicinal substances on the European market must provide the information on the labels. Companies must clearly state that their devices contain medicinal products and explain the relevant precautions, contraindications, and warnings.
Distributors of medical devices in Europe need to include specific symbols in addition to the requirements of the EU MDR and IVDR. All medical devices on the market must bear the CE mark. This mark shows that the devices meet all the requirements of the EU MDR.
This article might interest you ⤵️
2. Process Requirements
The process requirements for the distribution of medical devices in Europe cover import documentation, information about technical checks for compliance, and installation requirements. Distributors must meet all these requirements to distribute medical devices in any EU country.
Process for Compliance
The EU MDR specifies specific steps that companies that would like to distribute medical devices in Europe must take to achieve compliance. In a nutshell, the distributors should ensure that all the medical devices they would like to place on the European market have the CE marking.
Distributors should also have a declaration of conformity for the medical devices they would like to distribute in the European market. It is also necessary for the distributors to have all the information about the devices from the manufacturer and a unique device identifier.
Maintaining Accurate Records
Distributors of medical devices in Europe must maintain records of the products they sell. The MDR contains detailed instructions about the kind of records medical device distributors should maintain.
One of them relates to complaints from end users of the devices. Distributors are supposed to maintain records of all complaints about their medical devices. The distributors should also share the complaints from healthcare providers or patients with the manufacturers of the devices.
The EU MDR and IVDR have requirements for reporting adverse events. Distributors should report all cases of non-conformance to the manufacturers, importers, and other relevant economic actors, including the authorized representative of the manufacturer. Therefore, the distributor has the duty of determining whether a medical device they would like to distribute in the market conforms to the requirements.
Reporting Adverse Events
Furthermore, distributors of medical devices in Europe must report adverse incidents related to medical devices to the relevant authorities. Adverse incidents in this case refer to accidents or cases of high risk involving the use of medical devices. The distributor must provide all the accompanying documentation of the medical device to the authorities when reporting serious incidents.
3. Sales Tracking Requirements
The MDR and IVDR have detailed requirements for distributors to track the sales of medical devices they place in the European market.
Sales Tracking for Compliance
Sales tracking is important for compliance with the regulations. The ability to trace every medical device fosters safety and transparency. The authorities can trace complaints about specific devices and the corresponding manufacturer using sales records.
The essence of sales tracking requirements for medical device distributors in Europe is the ability of the distributor to identify all the other economic operators they work with. The economic operators in this case include the companies the distributor supplies the medical devices to and those that provide the equipment to the distributors. Also, the healthcare institutions that the distributor supplies the medical devices to are part of the economic operators the distributor should identify.
Requirements for Sales Tracking in Europe
Articles 27 of the EU MDR and 24 of the IVDR contain guidelines for tracking sales of medical devices across Europe. Distributors must cooperate with other economic operators in the industry to ensure full traceability of all medical devices on the market. Tracking of sales is possible because of the use of a unique device identifier (UDI). This unique number contains two parts: the device identifier and the production identifier.
The UDIs for all medical devices are available on the European Database on Medical Devices (EUDAMED). Stakeholders in the industry, including the authorities, can use the UDIs to track every device on the market. For example, manufacturers and distributors can use the database to report cases of non-compliance or serious risk. The public can also access information about medical devices on the database.
Examples of Effective Sales Tracking
The use of the UDI enables full traceability and tracking of the sales of medical devices. All distributors must ensure UDI on all the packaging of the medical devices they distribute on the market. The distributors should ensure the UDI is available in print format to complement the electronic format available in the database.
4. Discussions with Health Authorities & Failure Declaration or Non-conformities
The MDR and IVDR have provisions for distributors to report problems with medical devices to manufacturers and, in some cases, relevant authorities. The distributors must, therefore, collect all relevant information about the performance of the medical devices they place on the European market.
Collecting Feedback on Medical Devices
The distributors collect information about the performance of the devices from the healthcare providers they directly supply. Also, the distributors get data or complaints from other market operators they work with when distributing medical devices. Also, doctors and patients provide distributors with feedback about the performance of medical devices.
The Need to Report Medical Devices Problems
Distributors of medical devices in Europe must comply with the regulations and requirements about the need to provide information on medical devices. The use of the medical devices quality management system provides a framework for distributors to collect and share information about their medical devices with other economic operators in the industry. The MDQMS enables the distributors to access and share data about the non-conformance of medical devices.
Complying with Questions from the Authorities
Distributors need to communicate with the authorities about non-conformance. Non-conformance is a critical issue because of its repercussions on the safety of patients. An example of non-conformance may be a device that lacks the CE marking.
Distributors and manufacturers, therefore, use the MDQMS to effectively manage non-conformance and prevent the entry of faulty medical devices into the market. Furthermore, distributors of medical devices are responsible for identifying devices that do not conform to the regulations and informing the authorities and suppliers.
Conclusion
The EU MDR and IVDR laws provide detailed requirements for all distributors of medical devices operating in the European market.
These regulations cover various aspects of the roles of distributors of medical devices, as follows:
- Labeling the packages of medical devices
- Tracking the sales of devices
- The processes of attaining compliance
Medical device distributors must comply with the provisions of these pieces of legislation to avoid penalties. For example, the pieces of legislation have specific provisions for the labeling of medical devices.
- Medical device distributors must provide labeling information in two languages: local and English.
- The labeling must be in large and legible lettering to make it easy for users to read and understand.
- The labeling must contain critical mandatory information such as (but not limited to): manufacturer name, importer name, authorized representative name, date of manufacturing, shelf life, storage conditions, etc.
Process requirements relate to the need for distributors to maintain all relevant records about the other economic operators they work with in the industry.
The distributors must maintain records of the following economic operators in the industry:
- Persons they receive their stock from or their representatives
- Entities they sell the devices to, device serial number and sales date
Sales tracking ensures that information about every medical device is available on EUDAMED. Institutions and the general public can access the UDI and other data about every medical device in this database. Finally, distributors of medical devices in Europe must cooperate with the authorities whenever it is necessary. This level of cooperation entails sharing information about adverse events related to the devices they supply.
Masson International helps foreign companies search for medical device distributors in Europe as part of our goal to help companies thrive in new markets.
Disclaimer: We are not specialists in this matter; therefore, we cannot be sued for wrongful information or harm. Please check with experts and local authorities for up-to-date information.
