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.
  • Wound irrigation solutions containing 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”.

Navigate through our knowledgebase

Related articles

Article

Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices…

Read more

Article

Vanilla custard or custard with vanilla taste?

In a recent decision of the Board of Appeal of the Dutch Advertising Code Committee (ACC), it was made clear that providing food information to consumers is serious business. The ACC in the Netherlands is a self-regulatory body, comparable to the Advertising Standards Authority in the UK and the German Advertising Standards Council (“Deutscher Werberat”)  […]

Article

Trends at Vitafoods … and what you should know if you decide to be part of it

From 7 – 9 May 2019, the Vitafoods conference took place again in Geneva. For a few years in a row, I presented at the Education Program. This year I was asked to discuss the application of CBD in food products, which is currently a hot topic. Below, I will share the insight from my […]