Should legacy devices (MDD/AIMDD) have a UDI code?
No, legacy devices - i.e.devices complying with the old European Directives (MDD 93/42/EEC and AIMDD 90/385/EEC) - are not subject to [...]
10 07 2025
10 07 2025
10 07 2025
10 07 2025
For which Medical Devices does the MDR have specific UDI requirements?
The MDR sets out some special rules on UDI for certain categories of devices: Custom-made devices: No UDI code is required [...]
10 07 2025
10 07 2025
What are the requirements for UDI registration of systems and procedural kits?
According to Article 29 (2) of MDR (EU) 2017/745, before placing a system or procedural set on the market under Article [...]
10 07 2025
10 07 2025
What is the correct format of the expiry date to be reported in the UDI vector?
In the UDI vector (the GS1-128 or DataMatrix barcode on the label of the medical device), the expiry date must be [...]
16 06 2025
16 06 2025
Vietnam: End of Derogations for Import Licences as of July 1, 2025
The medical device sector in Vietnam has been the focus of significant regulatory reform in recent years. Decree No. 98/2021/ND-CP, in [...]
16 06 2025
16 06 2025
The UDI System for Medical Devices in Australia: News and Key Deadlines
March 24, 2025, marks a milestone for the medical device industry in Australia: on this date, the Unique Identification of [...]
16 06 2025
16 06 2025
510(k) Transfer in the U.S.: Public Comments Open on the New Draft Guidance
What happens when you intend to transfer or sell a 510(k) authorisation to another holder? The new FDA draft guidance seeks [...]
10 06 2025
10 06 2025
Post-Market Surveillance of Medical Devices in Great Britain: What’s Changing?
Post-market surveillance (PMS) of Medical Devices in Great Britain plays a key role in ensuring user safety and compliance. With the [...]
20 05 2025
20 05 2025
SAHPRA Joins MDSAP as an Affiliate Member: New Opportunities for MD Manufacturers in South Africa
In April 2025, the South African Health Products Regulatory Authority (SAHPRA) announced, with an official press release, its membership as an [...]
20 05 2025
20 05 2025
News on South Korea’s K-GMP Regulations for Medical Devices and IVDs
With the notice MFDS NO. 2025-22 dated April 7, 2025 the Ministry of Food Safety and Drugs (MFDS) of South Korea has [...]
