Clock Starts for New EU MDR Transition Dates
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
Tag Archives: notified bodies
The Real Impact of IVDR on Clinical Evidence Requirements
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
State-of-the-Art: Unpacking MDR’s Evolving Requirements
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
Ask the Expert: The EU Medical Device Regulation (MDR) – Is Anyone Ready and Where Are We Headed?
The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look.
Managing Testing Strategies Under the EU MDR
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
EU MDR: Will You Be Able to Sell Your Medical Device in Europe after May 26?
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
EU MDR: Changing World of Classification
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
New MDR: One Year into the Transition Period
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Medtech Companies Must Prepare for Brexit Now
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
Top Tips for Your Global Regulatory Strategy
Industry experts share advice that could influence company success.
