EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
