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May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers

Today, the EU medical device industry reached a major milestone with the arrival of the extended application deadline for the European Union Medical Device Regulation (EU MDR 2017/745).

NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.

UKCA: A Wait and Watch Approach?

On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.

EU Commission Update : Notified Bodies Designated to MDR/IVDR

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

The IVDR Compliance Roadmap: From Start to Finish

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.