MDCG updates guidance on device classification, EMDN, and supply disruptions

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), as well as guidelines on borderline and classification, European Medical Device Nomenclature (EMDN), and handling supply interruptions and discontinuations.

Device classification

As part of its document release, MDCG issued a revised guidance to help manufacturers classify their devices under MDR, replacing a guidance issued in October 2021. (RELATED: New MDCG guidance shows how devices fit into MDR’s classification rules, Regulatory Focus 6 October 2021)

The latest revision does not introduce significant changes to the classification rules established in the October version. Instead, it updates terminology and provides additional examples of device classifications.

Under the MDR, which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb, and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest. Annex VIII of the MDR further categorizes devices as non-invasive, invasive or active, or falling into another “special rules” category for contraceptives, contact lens solutions and device sterilizer.

The guidance provides a high-level overview of the regulations and graphical summaries to explain medical device classifications.

The revision clarifies important terminology. For instance, it expands the definition of an implantable device to include not only those that are surgically implanted but also those that are inserted through clinical procedures. In the 2021 version, implantable devices were defined exclusively as those inserted through surgical means.

The revision also clarifies certain classification rules in Rule 8 covering long-term and implantable devices. Two new notes were added on practical issues of classifying these devices. One of the new notes adds that “Article 52(4) states: ‘[…] for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.’ This does not imply classification of all sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors as class IIb. Such devices must be classified in their own right according to their intended purpose and the applicable rules.”

Under MDR Article 52(4), manufacturers must undergo conformity assessment procedures for class IIb implantable devices. It mandates that manufacturers undergo a quality system assessment and a review of technical documentation.

There is also new text in Rule 8, which clarifies what is meant by devices that come into contact with the spinal column. The previous version did not define the term "spinal column."

The new note adds that “contact with the spinal column should be understood as intended contact with any of the bony structures forming the column (cervical, thoracic, lumbar, sacral and coccyx) including the spinous and transverse processes of the vertebrae. Hooks that fix rods on the spinal column are considered similar to ‘screws, wedges, plates and instruments’ exemption in the last indent of Rule 8.”

Other changes include the reclassification of spinal hooks. Under Rule 8, hooks that fix rods on the spinal column have been added in the category of class IIb implantable devices. These devices were previously in the class III category.

Also, under rule 10 sunlamps are now considered and classified as class I devices. There is also the addition of two new devices have been added to the class IIa category; these include devices for visual electrophysiology and fluoroscopes for examining the eye.

Borderline and classification manual

The revised MDCG manual on borderline and classification for products under MDR and IVDR includes a new section on medical devices used to administer medicinal products. It lists several specific devices and how they are evaluated for safety and performance.

The revisions also include new sections on saline solutions for nasal irrigation and an update to the glossary to account for the new products covered under the manual.

EMDN FAQs

MDCG published a second revised version of a frequently asked questions document on EMDNs. The April 2026 version updates a January 2025 revision and adds four new questions to help manufacturers understand how regulators use the nomenclatures for medical devices and in vitro diagnostics in the European database on medical devices (EUDAMED). Among the new clarifications, the new document explains the difference between EMDN code extensions 90 and 92.

“EMDN levels with code extension 99 ‘Others’ represent generic terminal levels which can be used to classify devices that do not find a placement in specific terminal levels within the corresponding EMDN type,” said MDCG. “EMDN levels with code extension 90 ‘Various’ do NOT represent terminal levels, as they are hierarchically further detailed in EMDN.

“Therefore, no UDI-DI can be associated to a code extension ‘90’ for the registration in EUDAMED,” the group added.

Furthermore, MDCG provided insight on how to properly consult the EMDN to assign the correct codes and clarified that it includes a Category “X” that manufacturers can use for products without an intended medical purpose on the Annex XVI list. The group also noted that manufacturers can assign multiple EMDN codes to unique device identifiers (UDI-DI) that fall under different groups and product types with both medical and non-medical intended uses.

Supply interruptions and discontinuations

The updated documents released by MDCG also include a revised FAQ document detailing MDR and IVDR Article 10a manufacturer obligations to notify regulators of interruptions or discontinuations of medical supplies.

“In Question 9.2, the following note has been revised from ‘This question may be further complemented by a decision tree diagram’ to: ‘Note: This question is complemented by a decision tree diagram,’” said MDCG. “Footnote 10 has been updated and includes a link to the location of the decision tree diagram.”