SehaMed Newsletter (4th edition, 01/2023) ? Demo, MDR & Distribution Opportunities
Dear reader,
Another warm welcome to our monthly newsletter. If you have any questions, feedback or comments for us, please feel free to get in touch via?www.sehamed.com. We look forward to hearing from you! ??
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???Products of the month #surgery
THD S.P.A. is an Italian MedTech company which provides innovative solutions for the diagnosis and treatment of anorectal diseases. The company already operates at a global level and is looking to partner with distributors in various markets. Log in to view their full range and connect!
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?? European Commission proceeds with plan to delay Medical Device Regulation (MDR) transition to 2027/28
The European Commission is pushing ahead with plans to extend the deadline for transitioning to the Medical Devices Regulation.
Having accepted that notified body capacity “remains insufficient,” the Commission?shared a formal proposal to give manufacturers until 2027 or 2028, depending on risk classification, to get their devices designated under MDR.
The proposal has now moved to the European Parliament and Council for adoption.
Another major concern is the ongoing impact on medical device supplies. From medical device SME's to multinationals, companies have already removed a significant number of product lines from the EU market. The new cost of compliance has affected the financial viability for certain product ranges and even routinely used consumables have not been spared.
A Reuters’ report adds to evidence from other sources that manufacturers are already rethinking their portfolios in response to MDR and that manufacturers of products used in paediatric patients and rare diseases have been particularly hard hit. *
???Distribution Opportunities
Are you/do you know a manufacturer active in #neonatology, #ENT or #surgery?
If you are interested in connecting with our highly experienced distributors in Italy or Jordan, please get in touch and we will be happy to introduce you.
Thank you for reading and we wish those of you attending the WHX Dubai in Dubai next week a successful show!
*source: MedtechDIVE