(EU) 2017/745 Medical Device Regulation
Transitioning from the MDD to the requirements of the MDR
Following the successful introduction to the MDR that was provided by Boston® Materials at last year’s EFCLIN event in Dubrovnik, we are delighted to provide you with a comprehensive guide to some of the key aspects of the transition work that is required in order to meet the requirements of the Medical Device Regulation. In this section our own MDR expert – Alan Bennett – provides an update on the materials testing work that has been completed over the past year, along with some additional guidance on the Substances of Very High Concern requirements. Alan, as one of the MDCG Expert working group members, has also provided some insights into the additional requirements for Post-market Surveillance and Vigilance.
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Alan is a highly experienced medical device Quality and Regulatory professional working for Bausch & Lomb. Alan’s background is in speciality contact lenses and industrial engineering. Alan maintains a close and active working relationship with the EUROMCONTACT and serves as an industry expert representative on both the Post-Market Surveillance & Vigilance, and the Borderline & Classification working groups with the EU MDCG. Closer to home, in the UK, Alan also works on the UK trade association – ACLM – Technical Working Group, as well as serving as a member of the BSI ISO Standards Committee for contact lenses and contact lens care products. Working alongside a global group of Quality and Regulatory professionals has ideally positioned Alan to be your technical resource within the Boston® Materials group to help you with all materials based regulatory queries throughout the transition to the MDR and beyond.