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EU Regulatory Update April 2011
(Published April 2011)
We write with EU regulatory updates from the last few months.
New Edition of Borderline and Classification Manual
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.1
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.
European Commission Conference March 22, 2011
On March 22, 2011, the European Commission held a high-level conference on innovation in the medical technology sector. The conference expounded on topics such as regulatory reform and cost control, which will be considered in the recast of the medical devices directive. These discussions are expected to play a role in the future direction of many aspects of the medical device industry in the EU, and offer a valuable preview of things to come. A summary of the conference is available on the European Commission website at:
And copies of presentations are available at:
http://ec.europa.eu/consumers/sectors/medical-devices/links/hlc_2011_en.htm
Annual (2010) Vigilance Letters
As a reminder, if you received our Annual Vigilance letter, please find the time to complete it and return it to us at your earliest convenience. This form is to update Emergo Europe, as Authorized Representative, of manufacturers' vigilance activities, and confirm that no incident reports were required in the EU in 2010.
We have begun using a solution called EchoSign for electronic signatures; this will facilitate electronic signatures and, in the future, diminish our reliance on hard-copy contracts.
Emergo Group is ISO 9001:2008 Certified
Finally, if it was not known, we would like to make you aware that Emergo Group is an ISO 9001:2008 certified company. If the need ever arises, we will be more than happy to furnish a copy of our certification.
Best regards,
Evangeline Loh, PhD, RAC
EMERGO GROUP | Vice President of Regulatory Affairs
Footnotes:
1 http://ec.europa.eu/consumers/sectors/medical-devices/documents/borderline/index_en.htm
