This is article is outdated. Click here to consult Qarad’s newsitem dated February 4, 2019 regarding revision 1.21.
The European Commission’s Classification and Borderline Expert Group published a new revision of the “Manual on borderline and classification in the community regulatory framework for medical devices”. This 20th version includes all previously listed cases as well as the following new cases:
1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE – MEDICAL INTENDED PURPOSE
1.25. Mattress covers against mites
1.26. Lubricants intended for body massages and/or sexual intercourse
8.31. Trial hip prosthesis heads or stems
9. SOFTWARE AND MOBILE APPLICATIONS
9.9. Product intended to facilitate conception based on basal body temperature
9.10. Product intended to facilitate conception and enable contraception based on basal body temperature
9.11. Stand-alone software application for conception and contraception purposes using data entered by the patient
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 by the scope of the Directives, other Community and/or national legislation may be applicable.
What does this mean to you?
The manual only serves as a tool, the views expressed in it are not legally binding, and only represents the common understanding of the Medical Devices Directive and the In Vitro Diagnostics Directive between European national Competent Authorities and industry stakeholders. The manual may be referred to in product status or classification rationales, for example.
The manual is focused on the Directives and the definitions and classification pathways set forth therein, thus it has limited value to the Medical Devices Regulation and In Vitro Diagnostics Regulation.
Contact us if you need help to classify your products.
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