MassMEDIC, RAPS and the ASQ Biomedical Division held a day’s meeting in Waltham, Mass, USA on 19 June 2018 to provide information from expert speakers on how to implement the changes being brought about in Europe by the new Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746).

Among the speakers was Dr Maria E. Donawa, DLC’s President, who spoke on the subject of ‘Changes in EU Clinical Data Requirements and Expectations’. The session included an examination of changes related to clinical data under the MDR, the role of MEDDEV 2.7/1 Rev.4, planned EU clinical evaluation guidance documents for aiding compliance with the MDR, and the importance of an effective clinical data strategy.