The consolidated text of both MDR and IVDR prepared by the Luxembourg Presidency are available. Please follow the link to access the revised consolidated text of the recitals and articles of the proposed Regulation on medical devices prepared by the Luxembourg Presidency with a view to the finalisation of a General Approach, thus completing [...]
The COEN group, responsible for market surveillance published in cooridination with Swissmedic, A guidance related to the instructions for use (IFU) of resterilisable medical devices. This guidance is an user-friendly tool with checklists to help complying with ISO 17664. COEN_IFU-resteri-CL_EN-ISO17664_EN-ISO14937_v1.0
between the European Parliament on the future legislation are currently taking place. In this context, TEAM-NB, wishes to highlight several points still to be discussed between the Parliament and the Council. Enclosed our Position Paper on this negotiations.
pilot program to test a common electronic submission format for reviewing device submissions: 4 notified bodies members of Team-NB joined the pilot program (namely BSI, MDC, NSAI and TÜV SÜD).
held by Commission on August 26th : 3 Team-NB representatives were present.
NB withdrawals are due to three reasons, she said: not being able to conform to new regulations; following a joint assessment or competent authority audit; and/or mergers of NBs.
concerning the proposals prepared by the Latvian presidency and published by the Council of the European Union concerning the new medical devices regulations.
a conference on the theme of unannounced audits in Frankfurt
the substance on 2 Medical Devices draft regulations with a mandate to start talks with the European Parliament with a view to reach an agreement as early as possible.
