The Technical & Regulatory Update for August 2024 is now available in the Members Hub of the BDIA website.
This month’s update features the MHRA’s consultation on proposed fee increases, an important notice on an upcoming deadline for manufacturers to benefit from EU MDD certificate extensions, MedTech Europe and CAMD statements on the status of the EU MDR and US FDA guidance documents on user fees, reprocessing of devices and predetermined change control plans.
UK & EU
- MHRA launches consultation on changes to statutory fees
- Final deadline for EU MDD certificate extensions – 26th September
- MedTech Europe issues statement calling for European Commission to reform EU MDR
- European Medicines Agency pilot programme to support orphan medical devices
- CAMD statement on status of EU MDR
- European Commission renews UDI issuing entities under EU MDR
- European Commission survey on electronic Instructions for Use.
International
- US FDA publishes user fees for FY 2025
- Updated US FDA reprocessing guidance and FAQs
- CDRH discussion paper on health equity for medical devices
- Swissdamed actor registration module goes live
- US FDA electronic submission template for medical device De Novo Requests
- Draft US FDA guidance on predetermined change control plans
- Final US FDA guidance on electronic product user manuals
- US FDA finalises guidance on Voluntary Malfunction Summary Reporting.
