Clinical reports now available

November 21, 2018 Posted by Euromcontact

 

EUROMCONTACT contracted an external consultant, BizzAffairs, to produce Clinical Evaluation Report (CER) in accordance with the requirements set in the Medical Devices Regulation 2017/745 and in the Clinical Meddev 2.7.1/rev 4.
 
The CER covers astigmatism, irregular cornea, ortho K, presbyopia and myopia-hyperopia and was researched by Professor Clinician Jose Manuel Meijome. The CER comes with the relevant references for literature reviews.
The reports also include a section for manufacturers to fill in their own clinical data. These reports aim at supporting the technical file of manufacturers when looking for the CE mark under the Medical Devices Directive and, in future, in the Medical Devices Regulation.
The draft reports as well as the scientific process were presented at the EUROMCONTACT Workshop on Clinical Aspects of the MDR which took place on 26th September 2018.
 
The final reports are now on sale at the competitive price of 2,500.00€ to members of EUROMCONTACT. To order them, please contact the secretariat at pascale.rouhier@euromcontact.eu.

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