UK MHRA’s New And Increased Medtech Fees In Force in April
Executive Summary
One outcome of last year’s public consultation on UK MHRA fees is a hefty uplift in charges payable by medtech manufacturers in 2023, beyond which the agency is keen to pursue a new fees and charges plan.
You may also be interested in...
UK Updates Guidance To Reflect EU Medtech Extensions - Pledges Focus On Agility, Innovation
The EU’s decision to extend the Medical Device Regulation transition periods for legacy medical device directives products will be mirrored in the UK, which also continues to evolve its post-Brexit medtech regulatory system.
Diagnostics Industry Helps MHRA Shape IVDs Roadmap As Part Of Future UK Regulation
The MHRA will build its new UK system of medtech regulation on seven regulatory pillars, one of which is an IVD roadmap, says diagnostics industry association BIVDA. The trade body gave an update on the focus groups, UKAB numbers and timings for three awaited statutory instruments.
Switzerland’s Swift Reaction To MDR’s Extended Transitions Keeps EU Equivalency
The medtech regulatory authorities in Switzerland have pledged to follow the EU’s lead in granting extended transition periods for legacy devices under the MDR.