It looks as if the EU medtech regulatory system could survive intact in the UK, given terms of the UK blueprint for its future relationship with the EU after separation. But a storm of controversy must be navigated first.
It now looks as if the UK has found a way forward to fully implement the new EU Medical Device and IVD Regulations for the long term under a trade agreement with the EU. The agreement would even see the UK continuing to have some influence at EU level.
This would mean manufacturers would only need to undergo testing once, in either market, to be able to sell its...
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
