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FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today.


FDA plans reorganized “super office” for device regulation

The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report.


House votes (again) to repeal medical device tax

The U.S. House of Representatives voted 283-132 this week to repeal the 2.3% tax levied upon medical devices as part of the Affordable Care Act.


Getting ready for Europe’s new MDR - Clinical Evaluation

The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), published in May 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market.


Are You Prepared For The EU Medical Device Regulation? | Webinar | 29 November 2018

The EU Medical Device Regulation (MDR) was officially passed in May 2017 and manufacturers have until 2020, to be fully compliant with all changes set forth within the new regulation. View this 30 min. webinar to better understand the changes that clinical teams should prepare for now to be successful under the new regulation.


Final EU MDR, IVDR Texts Published

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published today in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations to commence on 25 May.


FDA seeks to bring clarity to combination product regulation

The FDA proposes a rule that would amend regulations regarding the classification of products as biological products, devices, drugs or combination products.


KPMG, RAPS survey finds many device makers ill-prepared for 2020’s EU MDR

An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020.


MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released today a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.


How will the GDPR affect your clinical trial?

The General Data Protection Regulation or GDPR is effective as of 25 May 2018 and it will bring substantial changes to the way medical device manufacturers and sponsors will collect and process personal data, including data concerning health.