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EU updated borderline manual - version 1.16


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Hi all,

Here is the summary of updates that EU has included in new borderline manual (version 1.16)

1. Bedwetting alarm - intended for treatment of nocturnal enuresis (recognized as medical condition) medical device Class I

2. Riboflavin solution for treatment of keratoconus (degenerative disorder of the eye which causes structural changes within the cornea) - supplied in the form of eye drops activated via UVA light, increases new bonds to form across adjacent collagen strands and so increasing the tensile strength of the cornea. According to new definition for medical device, riboflavin is increasing speed of the normal chemical processes participating in body function. So not Medical device.

3. Dentistry products with aluminum chloride used in haemostasia ? Stops perigingival bleeding during surgery by precipitation of albumins which in turn block the vessels (capillaries). Action is other than pharmacological, immunological or metabolic, qualified as medical devices.

4. Sterilization indicators - chemical and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items. Not fit into definition of medical device nor an accessory.

a. Strange part ? Indicators are class 2 devices in US

5. Software and mobile applications (Detail is given in guidance document MEDDEV 2.1/6 rev. 1)

a. A mobile application for processing ECGs - uses signal data from an external source and processes it to an ECG waveform (function other than just storage for the medical benefit of individual patients) standalone class IIa medical device.

b. Mobile app for the communication between patient and caregivers while giving birth - App store data on each moment of contraction during delivery, can make notes and take pictures for the purpose of exporting them to an external website. Intended use - to improve the quality of communication between the patient and caregivers, action on data limited to storage and simple search. Not medical device.

c. A mobile medical application for viewing the anatomy of the human body - To view illustrations of the anatomy of the human body (Educational or training purpose). Not medical device.



Super Moderator
The document “Manual on Borderline and Classification in the Community regulatory framework for medical Devices, Version 1.18” issued by European commission on Dec 2017. The revised Borderline Manual indicates that the following products should generally be classified as medical devices:

Alum styptic pencils (Class IIa)
Tissue expanders used in the breast (Class III)
Dura guard for use with a craniotome (Class III)
Heart bypass cannulae (Class III)
Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa)
Mobile application for the assessment of moles (Class I)


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