The Borderline Manual on Medical Devices has recently been updated, introducing five additional product examples that fall into “grey areas” of qualification and classification. Originally published in 2022, this guidance aims to support manufacturers in determining whether a product qualifies as a medical device and how it should be classified under the MDR.
1. Device Used to Administer a Medicinal Product
- Device overview: A single-dose mini tube with a long nozzle, used for rectal administration of a laxative. This packaging is not marketed separately but forms part of a combined medicinal product.
- Rationale: Although presented as packaging, the product performs a medical function by administering a medicinal substance into the body, bringing it within the definition of a medical device. As part of an integral medicinal product, it must comply with MDR requirements under Article 117, with evidence of conformity included in the marketing authorisation dossier.
2. Penis Holster
- Device overview:A device designed for incontinent patients, enabling urine collection by directing urine from the penis to a collection bag in both hospital and home settings.
- Rationale:Despite contact with the body, the device does not enter a defined body orifice under MDR terminology. Therefore, it is considered non-invasive and is classified as Class I under Rule 1.
3. Syringe Containing Glass Beads
- Device overview: A system used to collect, process, and prepare autologous conditioned serum (ACS) from a patient’s blood, involving incubation and centrifugation before reinjection.
- Rationale: The device alters the biological and chemical composition of blood beyond simple processing, placing it under Rule 3. As a result, it is classified as Class IIb rather than benefiting from lower-risk exceptions.
4. Needles for Root Canal Irrigation
- Device overview: Single-use flexible needles used during endodontic procedures to irrigate root canals after access is surgically created.
- Rationale: Because their use depends on a surgically created opening in the tooth, these needles are considered surgically invasive devices. Given their transient use, they fall under Class IIa according to Rule 6.
5. Saline Solutions for Nasal Irrigation
- Device overview: Saltwater solutions used to relieve nasal congestion by dissolving mucus, available in various formats (sterile/non-sterile, single or multi-dose).
- Rationale:As a substance-based device acting locally in the nasal cavity, the solution meets the criteria under Rule 21. Consistent with MDCG guidance, it is classified as Class IIa.
The updated manual provides further clarity on borderline cases and can be accessed using the following link
