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
More information on BizzAffairs can be found here.
EUROMCONTACT is the voice of European contact lens and lens care industry to the European Institutions, media, stakeholders and the public. EUROMCONTACT is the European Federation of National Associations and International Companies of Contact Lens and Lens Care Manufacturers. EUROMCONTACT members include national associations of manufacturers representing Belgium, Netherlands, Germany, Italy, Spain, Switzerland and the United Kingdom; the global companies Alcon, Bausch & Lomb, CooperVision, Johnson & Johnson Vision, Mark’ennovy, Menicon and the European Federation for the Contact Lens Industry EFCLIN.
For further information, please contact:
Pascale Rouhier
Secretary General EUROMCONTACT aisbl
10, rue de Tamines
1060 Brussels-BE
Phone/Fax : +32 2 537 37 11
Pascale.rouhier@euromcontact.eu – www.euromcontact.eu