New EU Commission guidance on medical devices borderline products and classification
Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual has been around for some years and is gradually amended and updated from time to time.
It is a very useful tool for determining whether a particular borderline product is regulated as a medical device or as e.g. a medicinal product, biocide or cosmetic product. The guidance is particularly helpful because it does not only explain the general thinking of the European Commission on borderlines and classification but also includes a growing number of specific cases and the underlying reasoning for classification as well as the decision under what set of rules the product is regulated. It also includes guidance on in vitro diagnostic devices.
This new version does not bring any important substantive changes. It merely adds and amends the guidance on three distinct types of products:
- contact lenses (par. 8.21), providing classification guidance for contact lenses, depending on the duration of uninterrupted use (overnight wear, daily wear, continuous wear or disposable)
- gallipots (1.19), a sterile or non-sterile container distinct in use from and therefore not to be confused with the specimen receptacle under the In Vitro Diagnostic Directive that can pride itself on some case law; and
- wound irrigation solutionscontaining antimicrobial agents (par. 8.20), clarifying the status of irrigation solutions intended for mechanical rinsing contain ingredients such as chlorhexidine, cetrimide, iodine, hypochlorous acid (HOCl), free chlorine (chlorine/chloride ion Cl2/Cl-), hydrogen peroxide, hypochlorous acid, hydrogen peroxide, chlorine dioxide, sodium hydroxide, sodium chloride and sodium carbonate to the effect that “a wound irrigation solution containing an antimicrobial agent, irrespective of the amount of the antimicrobial substance liable to act on the body, will be considered to be Class III according to classification rule 13”.