EUROMCONTACT runs a series of workshops to help its membership comply with the Medical Devices Regulation, starting with a workshop held on 3rd July 2018, entitled ‘Transiting from MDD to MDR’ in collaboration with the Notify Body NSAI.
On 3rd July 2018, EUROMCONTACT run a full day workshop in Brussels on the subject “Transiting from MDD to MDR’”, in collaboration with Colm O’Rourke, from the Notified Body NSAI. This workshop, which targeted in particular small and medium laboratories’ manufacturers of contact lens and lens care products, aimed at helping participants to identify & understand the new requirements and plan for implementation of the MDR.
In particular, Colm led the participants through a gap analysis from MDD to MDR on the General Safety Performance Requirements, and the General Obligations of manufacturers. In the afternoon session, participants went through the MDR and its effect on the quality management system. The workshop left time for an interactive participation and exchange between the speaker and companies representatives.
This workshop will be followed by a workshop in September 2018 on the clinical aspects of the MDR; and a workshop in October 2018 on the post-market surveillance requirements. More information is available on the website of EUROMCONTACT. These workshops are limited to EUROMCONTACT members.
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 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.
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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