Regulatory Updates affecting the EU Market

The European Commission has issued a new version of the "Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices." Version 1.9 was published in March 2011 on the European Commission website.

For those unfamiliar with this guidance, the manual is assembled from real-world cases of borderline product classification and represents consensus reached by European Commission's Working Group on Borderline and Classification. The manual is one of the more useful tools available to determine whether a product should fall within the purview of one of the medical devices directives, and the classification of the product.

EN 15986:2011 – "Symbols for Medical Devices Containing Phthalates"

The modifications of Directive 2007/47/EC on Annex I, section 7.5 of the Medical Devices Directive (Directive 93/42/EEC) imposed the requirement that certain medical devices that contain particular phthalates be labeled as such. The amended Directive reads as follows:

If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.

This requirement took effect March 21, 2010 with the implementation of Directive 2007/47/EC.

The European Committee for Standardization (CEN) has adopted the standard EN 15986 "Symbols for Medical Devices Containing Phthalates," which addresses the EU preference for symbols, and labeling requirements for phthalates, and is now available from various standards vendors.

This standard has not yet been added to the List of European Norm Harmonized Reference Standards (published in the Official Journal of European Communities); however, it is likely that it will be in the future.

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