News and Updates
Electronic IFU Medical Device: EU MDR Digital Proposal
Is the era of paper-based instructions coming to an end? The European Commission has launched a public consultation to update the regulation on electronic Instructions for Use (e-IFU). If adopted, all medical devices intended for healthcare professionals could use digital-only [...]
CMC Medical Devices at CMEF Shanghai 2025: Meet Us at Hall 8.1 Booth E10!
We’re back at CMEF Shanghai this year! From April 8 to 11, 2025, CMC Medical Devices will be present at one of the world’s largest medical device trade fairs, connecting with industry professionals, manufacturers, and regulatory experts. 📍 Find us [...]
The European Union and MDSAP: A New Opportunity for Medical Device Certification
The Medical Device Single Audit Program (MDSAP) is one of the most ambitious global initiatives aimed at harmonizing regulatory requirements for medical devices. In this context, MedTech Europe and COCIR have recently published a reflection paper urging the European [...]
New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
The European certification system continues to expand with the recent designation of two new Notified Bodies (NBs): CNCps (Spain) – Now designated for IVDR (EU Regulation 2017/746), increasing certification capacity for in vitro diagnostic devices. NSAI (Ireland) – Becomes [...]
New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant new opportunity for manufacturers of Class III and Class IIb active medical devices. This initiative, developed in collaboration with the European Commission, provides scientific support to companies to optimize their [...]
MDCG 2023-3 Rev. 2: Everything you need to know about the new vigilance rules
Important updates for manufacturers and importers: here’s what’s changing! The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 Rev. 2, introducing key changes to the vigilance and post-market surveillance of medical devices and IVDs in the EU. [...]
Australia: New opportunities for medical device and IVD manufacturers
The Therapeutic Goods Administration (TGA) continues to modernize Australia's regulatory system, introducing measures that simplify market access for medical devices and in vitro diagnostics (IVDs). Here’s what’s new and how these updates can impact your business. What’s Changing for Manufacturers? [...]
MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has released official guidance to help medical device manufacturers prepare for the updated Post-Market Surveillance (PMS) requirements, effective June 16, 2025. What is PMS? PMS is a mandatory system designed to monitor [...]
How to Ensure the Safety of Mobility Devices with Lithium Batteries: MHRA Recommendations
Lithium batteries are a critical technology for powering mobility devices such as electric wheelchairs and mobility scooters. However, if not managed properly, they can pose significant risks, including fire hazards that endanger users’ safety. To address these concerns, the [...]
