Contents In this issue 14 12 Numbers


The vital statistics impacting the market.


Regulatory


14 The eight-month countdown More than six months have passed since the transitional provisions of the Medical Devices Regulation (EU) 2017/745 (MDR) were amended to give more time to keep legacy medical devices available to the market – see Amending Regulation (EU) 2023/607. Manufacturers who wish to benefit from the extended time and still intend to submit applications under the MDR have only eight months left to submit before the May 2024 deadline. They should consider doing


so sooner rather than later. Petra Zoellner, director of IVDR-MDR at MedTech Europe, explains the conditions manufacturers must meet to secure an extension, and how they can communicate about the continued marketability of their legacy devices to European Union and non-EU authorities, payers and customers.


17 The consultant, the FDA and you


mdi Consultants


18 Staying ahead of shifting regulatory science


The pace of digital health product innovation is eclipsing the pace of regulatory science, and product


developers and manufacturers are in a position where they must navigate existing regulations while continuing to develop novel patient care features and product iterations. Smit Patel, associate programme director, Digital Medicine Society; and Megan Coder, vice president, product and policy, Digital Medicine Society, explain how a focus on achieving broad patient access, commercial viability and consolidated evidence- generation strategies can pave the way for manufacturers to navigate the complex landscape of regulatory requirements, ultimately satisfying the demands of various stakeholders.


21 A guide for outsourcing medical writing for medical devices Trilogy Writing & Consulting


Contract manufacturing


25 Sustainability in focus When it comes to health, we’re often more willing to accept the environmental impact associated with manufacturing the medical devices we need. But in a world in which sustainability is growing ever more important, contract manufacturers need to demonstrate a level of commitment to reducing their impact on the environment. Monica Karpinski speaks to Rory O’Keeffe, commercial director, Europlaz, and Daniele Fazio, vice- president of business development, Flex, to learn how their employers are improving their sustainability credentials, and how doing so can give them an advantage in the market.


30 Biocompatibility: A strategy for medical devices Qosina


25 4


33 A global manufacturing network for customers Carclo


35 Supplying despite the global struggle Halkey-Roberts


Medical Device Developments / www.nsmedicaldevices.com


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