Last month, the European Commission published an update to the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (version 1.16). The Manual was created by a working committee, composed of Commission services, experts from EU Member States and other stakeholders, that meets on a regular basis to discuss these borderline cases.
The Manual is intended to serve as a tool for device classification in cases that are unclear or for products that are excluded by the scope of the Directives, and provides examples of products or categories that have raised doubts. The views expressed in the Manual are not legally binding, but can greatly assist the task of device classification.
The new update includes classification decisions for the following products and categories:
- Bedwetting alarm ➙ medical device if intended for the treatment of nocturnal enuresis (Class I)
- Riboflavin solution for treatment of keratoconus ➙ not a medical device
- Dentistry products with aluminum chloride used in haemostasia ➙ medical device
- Sterilization indicators ➙ not a medical device
- New Section: Software and mobile applications
- Mobile application for processing ECGs ➙ medical device (Class IIa)
- Mobile application for the communication between patient and caregivers while giving birth ➙ not a medical device
- Mobile medical application for viewing the anatomy of the human body ➙not a medical device
More information about these products and the rationale behind their classifications are provided in the text of the Manual. Also covered are classification decisions for 68 other products and categories, including light boxes, gallipots, peritoneal dialysis solutions, eye drops and disinfectants.
Whenever classifying a device in the EU, it is important to utilize other source documents in addition to the Borderline Classification manual:
- The Directives covering medical devices, active implantable devices or in vitro diagnostic devices (MDD Directives, AIMD Directives or IVDD Directives, as appropriate)
- o2.1/1: Definitions of “medical devices”, “accessory” and “manufacturer”
- o2.1/2: Field of application of directive “active implantable medical devices”
- o2.1/3: Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative
- o2.1/6: Qualification and Classification of standalone software
- o2.14/1: IVD Borderline and Classification issues. A guide for manufacturers and notified bodies
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European Commission. Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. Version 1.16, July 2014. Available at:http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf.
European Commission. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF.
European Commission. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:EN:PDF.
European Commission. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20090807:EN:PDF.
European Commission. Guidance MEDDEVs. Available at: http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.
European Commission. Reference Documents. Available at:http://ec.europa.eu/health/medical-devices/documents/index_en.htm.