Borderline Devices: Definitions and Requirements
This White Paper provides the necessary definitions and requirements for borderline devices, in particular for substance-based devices including a medicinal [...]
29 11 2023
29 11 2023
22 11 2023
22 11 2023
INDIA: Import Licence Now Required for Class C and D Devices
On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) published on its official website the Regulation of Class [...]
22 11 2023
22 11 2023
USA: FDA Inspections of Manufacturers Planned as of January 2024
Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which covers [...]
22 11 2023
22 11 2023
EUROPE: MDCG Mdcg Approved the Medical Device Software Guideline in Combination with Hardware
Last October 2023, the Medical Device Coordination Group (MDCG) approved the MDCG 2023-4 Medical Device Software (MDSW) - Hardware combinations [...]
25 10 2023
25 10 2023
3 Things to Know About Substance-Based Medical Devices
26 October 2023 Substance-based Medical Devices are specifically regulated by the MDR (EU) 2017/745, starting with the classification in Rule [...]
20 10 2023
20 10 2023
USA: 510(K) Submission Only With eSTAR Portal
On October 2, 2023, the FDA published an update to the Electronic Submission Template for Medical Device 510(k) Submissionsguidance: Guidance for [...]
20 10 2023
20 10 2023
EUROPE: Cybersecurity for High-Risk Artificial Intelligence Systems
On September 11 2023, the European Commission published on its official website the Cybersecurity of Artificial Intelligence in the AI Act, [...]
20 10 2023
20 10 2023
SWITZERLAND: Regulation of Devices Not Intended for Medical Use
On September 29, 2023, the Swiss Federal Council amended the Medical Devices Ordinance to improve the safety of products not intended [...]
27 09 2023
27 09 2023
Artificial Intelligence in Medical Devices
29 September 2023 What is artificial intelligence? Artificial intelligence (AI) is a branch of computer science dedicated to creating systems [...]
20 09 2023
20 09 2023
What is meant by documents (or list) of external origin?
Documents of external origin are considered to be regulations, laws, binding and/or applicable regulations, technical standards and any other public or [...]
