Down-classify SARS-CoV-2 IVDs?
In July 2024 the MDCG has requested the EMA to review whether SARS-CoV-2 IVDs classification remains appropriate.
Blog
EDDO for combination products
Essential drug delivery outputs are critical to ensure the reliable and accurate functioning of the drug delivery system
Impact of AI act on medical devices
The AI Act introduces new regulatory obligations for medical device manufacturers, particularly those utilizing AI in high-risk applications.
Orphan devices under MDR
Flexible approach for the clinical evaluation and regulatory approval of orphan medical devices under the EU MDR
Coding adverse events
Coding adverse events according to the IMDRF guidance ensures consistent reporting across multiple jurisdictions
Change of US-FDA QSR
The US FDA published a final rule to amend the device CGMP requirements of Quality System Regulation to closely align with ISO 13485
Usability vs. Clinical Investigation
Both usability studies and clinical investigations are essential as they serve different purposes and complement each other…….
New amendment of IVDR & MDR
European Commission has proposed a new regulation to amend the current MDR and IVDR to prevent interruption in the supply chain.
Classification remains challenging
The 16% refusal rate of MDR applications due to wrong qualification and classification of device is indeed noteworthy
Importers’ readiness
Regular assessments, ongoing training, and close collaboration with regulatory authorities and stakeholders are crucial for importers….