The European Commission (EC) has released two new guidance related to the nomenclature of medical devices.
CND Nomenclature: Key Points
The first document published by the EC describes the “Classificazione Nazionale Dispositivi medicini” or the CND – the official Italian classification of medical devices. This classification has been used by domestic and foreign manufacturers to register their devices in the Italian national database. It was implemented to provide additional standardization and structure in the way information on medical devices is provided to all parties involved.
The CND utilizes three key principles:
– Participative approach providing that all parties involved in operations with medical devices should take part in the improvement of nomenclature since a wide range of special knowledge is needed to ensure that it is correct and accurate.
– Qualified validation of proposals meaning that all proposals should be subject to validation with regard to other generally accepted classification systems, information about consumption and expenses, and consultations with the professionals from various spheres.
– Formal adoption and public availability. Under this principle, the CND is an officially approved system, its provisions are freely accessible and could be used by all parties involved for reference purposes.
It is also important to mention that the CND does not include medicinal and cosmetic products, human blood and certain other products of human origin, or individual protection devices.
CND Structure
The CND utilizes the alphanumeric principle in its internal structure and includes such levels as Category, Group and Type. The code assigned to the device includes a letter and two groups of digits to indicate the appropriate Category, Group and Type respectively, composing of up to 13 digits in general. The Type could be also expanded into additional levels if necessary.
On the first level, there are 22 Categories marked with letters. Each Category includes the devices grouped due to the specific of application (anatomical categories) or the intended purpose of the device stated by the manufacturer (functional categories). It is also important to mention that there are five Special Categories based on principles other than the two described above. Groups are used to provide additional classification inside each Category. In general, there are 146 Groups identified by two-digit numbers. The lowest level is presented by Types. Each type includes devices that are similar due to particular criteria, such as intended use. The system also contains special Type “Other” to be applied for the devices that do not fit any of the existing types.
All accessories for medical devices should be assigned to the same code as the initial device depending on the intended purpose. If such an accessory could be used in connection with various devices, the code should be defined in accordance with one that prevails.
If the medical device manufacturer fails to define the appropriate class, it is provided that a special class addition request should be submitted to the regulating authority. Such a request should contain a detailed description of the device including the aspects making it unsuitable for any of the existing classes. The regulating authority would also analyze all information collected from various sources and parties involved in operations with medical devices to keep the system efficient and up to date. Thus, the system is designed to be flexible enough to deal with the situation when certain devices fall outside of the scope of the initial classification structure.
European Medical Device Nomenclature And EUDAMED
The second guidance is dedicated to the European Medical Device Nomenclature (EMDN) established to be used by manufacturers for the purpose of registration in the EUDAMED database.
EUDAMED is a new European medical device database created on the principles set forth by the Medical Devices Regulation 745/2017 (MDR) and In Vitro Medical Devices Regulation 746/2017 (IVDR). EUDAMED is designed to be used for several purposes, including registration of medical devices, information exchange and collaboration between notified bodies and regulating authorities, publication of notifications and also to disclose to the public information that should be publicly available due to its nature (e.g. information on safety and performance of medical devices). In other words, EUDAMED is intended to make the information exchange effective and transparent and to improve the traceability of medical devices. To achieve these goals, the system would utilize several special modules, each responsible for a particular type of information. The draft functional specification for EUDAMED should be developed by the European Commission while the MDCG focuses on the development of particular steps aimed at the implementation of the new system. The specifications would set forth the main requirements that all parties operating the system should follow to maintain the accuracy of information uploaded to the database. Under these specifications, all information should be provided in a structured way to make it possible for various parties to use it.
In particular, the information stored in EUDAMED would consist of:
– Information on the medical device manufacturers, their authorized representatives, and the devices themselves,
– Information on the certificates issued by notified bodies and other parties entitled to issue them, including information on any changes or modifications thereto,
– Information collected in the course of post-marketing surveillance procedures, including the detailed data from adverse events reports and investigations, performed to assess the associated issues.
It is also important to mention that the actual launch of EUDAMED is subject to delays.
The new nomenclature is based on the utilization of the pre-defined criteria and also on the core principles developed by the Medical Device Coordination Group (MDCG), a voluntary group of medical device regulating authorities collaborating to improve the regulatory framework. The document also includes general principles contained in the CND.
As the CND, the EMDN would be freely accessible so that all parties involved could use it for references. It would also be connected with the Global Medical Device Nomenclature (GMDN). This will allow the identification of correspondence between these two classification systems. The guidance emphasizes the importance of international cooperation to ensure the accuracy of connections (i.e. “mapping”) between these systems. According to the document, a special group within the structure of the MDCG has been established for the purpose of coordination of all the issues arising in connection with the improvement of the nomenclature systems. It is also important to mention that the European Commission also actively takes part in this process actively working with the World Health Organization (WHO).
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
https://ec.europa.eu/docsroom/documents/39009?locale=en
https://ec.europa.eu/docsroom/documents/39007?locale=en
https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en
