The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a questions-and-answers document dedicated to the European Medical Device Nomenclature (EMDN).
It is important to mention that the document should not be construed as one officially issued by the European Commission. Hence it is not intended to introduce new requirements and procedures but provides additional clarifications on the matter. The scope of the document covers the most important aspects related to the EMDN and how it should be used in the context of the European database on medical devices (EUDAMED).
The European Medical Devices Nomenclature: Key Points
Initially, the use of the EMDN is prescribed by the new regulatory framework for medical devices comprised of the newly adopted regulations:
- The medical devices regulation 2017/745 (MDR), and
- The in vitro diagnostic medical devices regulation 2017/746 (IVDR).
The aforementioned regulations are intended to replace existing directives and introduce a new regulatory approach for medical devices marketed and used in the European Union. According to the Regulations, the EMDN should play an important role in the operations of the new union-wide database containing information about medical devices, the EUDAMED. For instance, the nomenclature should be used when applying for the registration in the database, together with the use of Unique Device Identifier – Device Identifier (UDI-DI). According to the guidance, as the EMDN primarily serves regulatory purposes to support MDR and IVDR requirements, it also plays a key role in MDR/IVDR device documentation and technical documentation, sampling of technical documentation conducted by notified bodies , post-market surveillance, vigilance, and post-market data analysis, etc. It is intended to support all actors in their activities under the MDR/IVDR and provides key device descriptions to patients as regards their own devices and all other devices available on the market and registered in EUDAMED.
Creation of the EMDN
The MDCG states that the new European medical device nomenclature is based on the Italian Ministry’s “Classificazione Nazionale Dispositivi medicini (CND)” further adopted by the European Commission by virtue of the appropriate notice. It is important to mention that the CND has already been actively used in several European counties. It took several years to carry out consultations with industry representatives, experts, and other parties involved. The initial version of the EMDN was published in May 2021.
EMDN Key Principles
The guidance further describes the main principles on which the new European medical device nomenclature is based, namely:
1. Regulators-led: significant input from the regulating authorities responsible for managing and updating the nomenclature;
2. Structured: the elements of the nomenclature should be combined into groups in order to create a clear and transparent structure;
3. Predictable: the composition and structure of the nomenclature should be stable enough to simplify its use. However, a proper balance is needed to ensure sufficient flexibility to incorporate changes reasonably necessary due to further development of technologies;
4. Transparent: the procedures to be followed when amending or updating the nomenclature should also be clear enough;
5. Inclusive: the nomenclature should be subject to periodic reviews;
6. Available: all the elements of the EMND should be available to its users;
7. Accessible: access to the nomenclature should be provided on a cost-free basis, ensuring that all interested parties have equal rights to access the EMND and its components;
8. International: the new nomenclature should be recognized on the international level.
Getting Access to the EMND
As mentioned, the new European medical device nomenclature should be available for free for all interested parties, including medical device manufacturers, healthcare professionals, and organizations, as well as patients. According to the guidance, the nomenclature could be downloaded as a file available for offline use. The MDCG also mentions the public consultations finished earlier on June 4, 2021. The consultations were intended to collect suggestions from interested parties regarding the English version of the nomenclature, especially in terms of translation errors or similar issues. Once the suggestions received are processed, a new, second version of the European medical device nomenclature will be issued. The release of a new EMND version is scheduled for the third quarter of the year 2021. Apart from minor changes and corrections of errors, the new version will also contain some new terms and descriptions.
In order to assist medical device manufacturers and other interested parties in using the EMDN, the present MDCG guidance also describes in detail the internal structure of the new nomenclature. According to the document, it contains a hierarchy based on the alphanumeric structure.
It has the following levels:
- Categories: the first hierarchical level,
- Groups: the second hierarchical level,
- Types: the third hierarchical level (which expands into several levels of detail (1, 2, 3, 4, and 5), where necessary.
The guidance also provides a scheme visualizing the structure described above.
The first letter in the alphanumeric code is used to indicate the particular category of a medical device in question. The next two numbers refer to the group, while the rest of the numbers refer to the type of medical device. It is stated that the length of a code should not exceed 13 digits.
EMDN Level to be Used
According to the present MDCG guidance, using the tree-like hierarchy of EMDN, users must always assign the most granular and terminal term available (lowest level in the tree) to their device.
As mentioned in guidance documents issued previously by the MDCG, the new European medical device nomenclature will also be connected to the Global Medical Device Nomenclature (GMDN). It is stated that the appropriate measures are required to ensure the efficient and accurate connection between the aforementioned systems.
All the matters related to further development and improvement of the new nomenclature are handled by a special workgroup within the MDCG.
EUDAMED in Brief
The EUDAMED, a new union-wide database for medical devices, has been created for the purpose of ensuring the efficient exchange of information related to medical devices marketed and used in the EU. It will also be used to improve cooperation between notified bodies and regulating authorities, as well as to improve and expand the availability of information about medical devices. In addition, it will improve the traceability of medical devices and simplify access to important safety-related information for all the parties involved. The system itself will comprise several functional modules.
In summary, the present questions-and-answers document published by the MDCG provides additional clarifications regarding the new European medical device nomenclature, its structure, main principles, and intended purpose. The document also provides recommendations on the way it should be used by the medical device manufacturers and other parties involved.
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