How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
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 UK’s Medicines & Healthcare products Regulatory Agency will continue to recognize CE Marked products for use in the country for a limited time following a ‘no deal’ Brexit scenario, according to new guidance from the agency.
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.
Which medical devices fall under the EU MDR scope?
By when do I need to update the Clinical Evaluation Report?
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.
Which country should I go to for my clinical trial?
Why is it important for manufacturers to focus on the health economics of their device?