MedTech Europe warns that until challenges are resolved, roadblocks will continue to limit the sector’s ability to seamlessly supply certified devices under the new rules.
Almost Three-quarters of Medical Device Companies Ready to Meet the European Union s MDR and IVDR Regulations, According to RWS Research
05/10/2021 | 03:01am EDT
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Despite optimism, almost half admit COVID-19 will have long-term impact on strategic planning
A research report from RWS, the world’s leading provider of technology-enabled language, content management and intellectual property services, highlights the impact of COVID-19 on medical device manufacturers, and their readiness to meet the European Union’s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadline.
The research, involving leading medical device organizations operating in Europe, looks at how the pandemic has affected their preparations to meet the 26 May 2021 deadline for the EU MDR, and EU IVDR deadline of 26 May 2022. The research paints an optimistic picture: almost three-quarters (70%) of organizations are positive about meeting the MDR deadline,
As Europe Prepares for New Regulations, RAPS Euro Convergence Gathers Regulatory Pros Online for Updates, Discussion, and Debate, 10–12 May
April 22, 2021 13:56 ET | Source: Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Professionals Society (RAPS) Rockville, Maryland, UNITED STATES
Rockville, MD, USA, April 22, 2021 (GLOBE NEWSWIRE) The Regulatory Affairs Professionals Society (RAPS) will hold its annual RAPS Euro Convergence, a three-day conference devoted to European healthcare product regulations and regulatory issues,
10–12 May. This year’s program will feature more than 130 expert speakers and more than 40 educational sessions taking place all online. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA), national health authorities, notified bodies, and the medical device and pharmaceutical industries.
As Europe Prepares for New Regulations, RAPS Euro Convergence Gathers Regulatory Pros Online apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.