Hamburg, Germany

News

Always up to date

Stay informed about the latest news and developments in medical technology – if you're interested, subscribe to our NSF Newsletter.

The U.S. Food and Drug Administration (FDA) has released a new draft guidance providing guidance on frequently asked questions regarding the transfer…

Read more

With the entry into force of the "Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024" on June 1,…

Read more
[Translate to English:]

Commission Implementing Regulation (EU) 2025/1234 significantly broadens the possibilities for electronic instructions for use (eIFU) for medical…

Read more

The MDCG 2025-6 guidance document, jointly adopted by the Medical Device Coordination Group and the Artificial Intelligence Board, describes how the…

Read more

The European Commission has published Revision 1 of the MDCG Guideline 2019-11 and introduced important clarifications for medical device software…

Read more

On June 16, 2025, the EU Commission published the "MDCG 2025-4 – Guidelines for the Secure Provision of Medical Device Software (MDSW) Apps on Online…

Read more

Already on April 4, 2025, the South African Health Products Regulatory Authority (SAHPRA) announced its affiliation with the Medical Device Single…

Read more

The MHRA has updated the MORE system and the underlying reporting requirements for medical devices in the UK. These changes come into force on June…

Read more

The European cybersecurity agency ENISA has launched the beta version of the European Vulnerability Database (EUVD). ENISA was already approved as a…

Read more