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.
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.
Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise.
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.
The U.S. medical device industry is facing nearly $1 billion in tariffs from the Trump administration, about $4 billion less than what was originally expected. Customs and Border Protection began collecting the additional duties on July 6.
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.
Post-market surveillance is an important process for medical device developers, with regulatory bodies expecting you to follow through and have effective procedures.
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.