EU MDR has made it harder to bring devices to market, says CRO
EU device regulations are complex and smaller developers can struggle to bring products to market according to new clinical research organization (CRO) Bevinced.
The Amsterdam-based CRO shared its thoughts on the EU device market when it launched last month, explaining the recent Medical Device Regulation (MDR) has had a significant impact on developers.
Chef medical officer Joris Bannenberg said "The MDR has a huge impact on the availability of certain medical devices. Especially smaller companies and start-ups may not have enough funding to outsource the MDR's Post Market Surveillance programs. For this reason, some companies have even taken their devices from the market.”
Bevinced’s take is in keeping with a study published in July, which suggested the MDR has introduced new uncertainties which present barriers to getting devices to the global market.
To that end, Bevinced will aim to win customers that looking to navigate the complex web of quality, safety and efficacy regulations that govern medical devices in all 27 EU member states.
“We see a real need for high-quality services but at lower costs; Bevinced can do that with knowledge, supporting digital technologies, well designed studies, and a nimble organization."
Bannenberg and Bevinced co-founder and CEO Dirk Meijer have significant experience working in the medical devices space. Together they set up Factory CRO, since renamed Avania, in 1988.
And this experience will shape Bevinced’s approach to the market according to Meijer.
"We are thrilled to launch our niche CRO services for the MedTech industry. Bevinced's team of experts in clinical research and regulatory compliance is dedicated to supporting its clients in navigating the complex regulatory landscape and bringing and keeping their innovative medical devices to the EU market.”
Bevinced will provide clinical trial design and management, regulatory strategy and submissions, post-market surveillance, vigilance, CER-writing and technical documentation support as well as legal representative services.
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