Europe – Notified body perspective: Evaluating uses for real-world data
Real-world data (RWD) can provide useful information that may be included in clinical data submissions, but the greatest value may be during the postmarket...
UK – MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is taking forward its new ‘regulatory sandbox’, the AI-Airlock, that will provide a...
Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.
Cracks in the current...
Europe – Experts outline current knowledge on AI and medical devices
With European legislation on how to regulate the integration of artificial intelligence (AI) into daily life on the horizon, it’s time to consider how...
UK – MHRA and international partners publish five guiding principles for machine learning-enabled medical...
The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support...
Europe – In vitro diagnostic device regulation in Europe: Update on revisions
The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework...
Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
Software has become an increasingly important part of the medical device landscape. It is
estimated that one in four medical devices either incorporate medical device...
Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device...
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002...
Europe – The European Medical Technology in Figures 2023
Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business leaders and policymakers.
Updated regularly, this platform draws on data from...
Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process...
