Weekly Business Insights 07/08/2025

Health products policy and standards

Medical devices include all the health technologies (except for vaccines and medicines) required for prevention, diagnosis, treatment, monitoring, rehabilitation and palliation. Following the WHA75.25 decision: Since 2023, WHO has been using  EMDN codes and terms  and since  March 2024, WHO can also use  GMDN terms, codes and definitions in WHO documents and databases. Therefore,  MeDevIS has included EMDN and GMDN nomenclature systems and will be expanded to other WHO databases and publications.

Several systems exist today to name and classify medical devices. Each system is used by a different group of professionals depending on the needs of that group. Such needs include: regulatory approval, procurement and supply, customs operation, inventories and maintenance, among others. Some countries and organizations have developed their own national systems that are not compatible across systems.

On 23 January 2021, WHO Executive Board 148 discussed the EB148/13 Standardized Nomenclature of Medical Devices Report. The report proposes that  WHO will neither develop a new nomenclature of medical devices nor adopt a proprietary system but harmonize with the European Medical Device Nomenclature, which will support regulation, assessment and management of medical devices to improve access. Statements by Member States are available on the webcast Executive Board 148. 

Health products policy and standards

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Classify Your Medical Device

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. 

FDA Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labelling but may also be conveyed orally during sale of the product.

The offset here in FDA classification system assigning a GMDN to the product category, for Ex: Urinary catheters, and they have a sub classification, “indwelling catheters” then all the products that comes under this subcategory is listed with the GMDN, which includes parts of the whole system. As of now a unique identifier of a device is the FDA classification system but cannot be considered unique.  

Classify Your Medical Device | FDA

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How are Medical Devices Classified under EU MDR?

In the EU, medical devices are regulated by the European Commission (EC). Back in 2017, the EC set forth it’s new regulations for medical devices—The European Union Medical Device Regulation, or EU MDR 2017/745. The MDR, as it’s commonly referred to, is the document that covers medical device classification in the EU, and it supersedes the existing Medical Device Directive (MDD).

The EU MDR stipulates that a medical device must receive a CE marking in order to be legally sold on the EU market. The acronym CE stands for Conformité Européene, which translates to “European conformity.” Basically, in order to obtain the CE mark, a  conformity assessment will need to be conducted based on the risk class of the medical device to ensure it complies with all applicable regulations required by the MDR.

Greenlight Guru's QMS software is the only industry-specific solution of its kind. The cloud-based software is aligned with the latest industry standards and provides full traceability throughout the lifecycle of your medical device—a new requirement of the MDR that no other solution can match.

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