Press Room
Press releases and interesting articles.
These press releases and articles can be used for publication if EUROMCONTACT is mentioned as the source.
Click on the item to open the file.
Assottica elects new Board
 EUROMCONTACT PUBLISHES IMPORTANT NEW REGULATORY DOCUMENTS:
- updates for the Clinical Evaluation document
- A Risk Assessment Guidance Document
EUROPEAN CONTACT LENS FORUM SEMINAR ON DISTRIBUTION CHANNELS OF CONTACT LENSES
Press release
EUROMCONTACT 2010 STATISTICS: Press release
Tables
EUROMCONTACT press release on the ECJ ruling Ker-Optika case.
ACLM publishes 2010 Yearbook
Internet sales of contact lenses: EUROMCONTACT statement
ACLM publishes 2009 data and technical summary
EUROMCONTACT WELCOMES MARK'ENNOVY AND NAC
THE EUROPEAN CONTACT LENS FORUM has published "Contact Lens Queries" to be used by eye-care professionals. It contains and extensive list of questions and answers related to contact lens wear and care. Click here to download the complete document
EUROMCONTACT AISBL publishes Clinical Evaluation document.
The 2007 revision of the European Medical Device Directive (2007/47/EC) introduced among many other changes, ‘… that clinical data is generally required for all devices, regardless of classification …’, as an essential requirement to be fulfilled for all classes of medical devices. The essential requirements must be met in order to put the CE mark on the product. The clinical data is usually based on data from clinical studies, which may not be available for some contact lenses that were first placed on the market many years ago and continuously supplied thereafter. One solution is here to use published scientific articles to demonstrate fulfilment with this essential requirement. From 2010 onward, Notified Bodies will be looking for these data in a greater degree of detail than would have been accepted in the past.
The EUROMCONTACT Regulatory Affairs Focus Group commissioned a generic clinical evaluation document that manufacturers can use to help demonstrate compliance to the clinical requirements. This literature review covers published literature on existing contact lens materials and modalities up to the present (2008) and focused mainly on peer reviewed articles. It contains over 400 references. It was developed by the internationally recognized experts Dr. Michael Port and Dr. Graeme Young (Vision Care Research – UK) who reviewed all the literature provided by EUROMCONTACT plus hundreds of published articles from various databases. It provides summaries of the safety and effectiveness of the different types of contact lenses on the market. It will save you time and thousands of Euros by providing you with the first step toward meeting the essential requirements.
CLEER PROJECT ENDED 31/12/2009
The www.cleer-project.eu was launched on June 1st 2008 and ended on December 31, 2009. The results are now in the process of being analyzed. For further information please download the press release.
CLEER Project Press Release in English
CLEER Project Press Release in French
CLEER Project Press Release in German
EUROMCONTACT ELECTS NEW PRESIDENT AND SECRETARY
MEMBER NEWS
ASSOTTICA elects Institutional Contact Lens Group Offices for the years 2010-2011.
ACLM Board changes 2009
October 2006: "Contact Lens and Teenagers" Italy (PDF)
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