borderline and classification medical devices:

UPDATED MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.16 (07-2014)

Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device, but is excluded from the Directives by their scope. Where a given product does not fall within the definition of medical device or is excluded from the scope of the Directives, other Community and/or national legislation may be applicable.

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

1. Bed wetting alarm – intended for treatment of nocturnal enuresis (recognized as a medical condition) medical device Class I

2. Riboflavin solution for the treatment of keratoconus (a 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 of medical device, riboflavin is increasing the speed of the normal chemical processes participating in body function. So not Medical device.

3. Dentistry products with aluminum chloride used in hemostasia – 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 a definition of medical device nor an accessory.

a. Strange part – Indicators are class 2 devices in the US

5. Software and mobile applications (Detail is given in the 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 storing for the medical benefit of individual patients) standalone class IIa medical device.

b. A 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.

Notes:

• This manual represents the views agreed in this group on products, or categories of products, which have raised doubts. The Commission, Member States and other stakeholders concluded that guidance is needed, which goes beyond abstract rules and addresses their actual application.
• However, please note that the views expressed in this manual are not legally binding, since only the European Court of Justice (“the Court”) can give an authoritative interpretation of Community law.
• This manual does not relieve national competent authorities from their obligation to render decisions in these areas for any individual product, on a 7case-by-case basis. National authorities, acting under the supervision of the courts, must proceed on a case-by-case basis, taking account of all the characteristics of the product.
• Therefore, this manual shall not “prescribe” which regulatory framework applies or how the classification rules must be applied by national authorities. Rather, it shall serve as one out of many elements supporting the national competent authorities in their case-by-case decision on individual products.
• In particular, this manual does not deprive a national authority to consult with colleagues from other regulated sectors concerned in order to reach a complete view on all aspects related to a given product.
• This manual will be updated in the light of the outcomes of the discussions of the working party on the borderline and classification issues.

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