Australia 2024 Update: Market Authorization for Medical Devices
An update to Australia’s guidance on the use of market authorization evidence from overseas regulators for medical devices, including in-vitro…
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EU Cosmetics Regulation 2024: New Ingredient Restrictions
On April 3, 2024, the European Commission adopted Regulation (EU) 2024/996, bringing further amendments to the Cosmetics Regulation (No. 1223/2009).
New Modifications on Vigilance Terms from MDCG
MDCG has made minor modifications to the MDCG 2023-3 guidance, “Questions and Answers on vigilance terms and concepts…
FDA Draft Guidance on AI-Enabled Device Submissions
The FDA has issued their draft recommendations (January 2025), regarding the content of marketing submissions for medical devices that…
New Post-Market Surveillance Rules for UK Medical Devices
The publication of Statutory Instruments 2024 No. 1368 introduces significant amendments to the Medical Device Regulations in Great Britain. These…
TGA Consultation: Medical Device Audit Framework
The Therapeutic Goods Administration (TGA) has announced a public consultation on two draft guidance documents as part of its new…
New MDR and IVDR Factsheet from the European Commission
A new MDR and IVDR Factsheet for healthcare professionals and health institutions was published on 18th December by the European…
Team NB Releases Document on the MDR Certification Process
Team NB has released a new document titled “MDR Certification Process (including Pre-application, Application, and Post-application Phases) – Consensus Document.”…
EU MDR/IVDR Update: Revised MDCG 2019-13 Sampling Guidance
The European Union has released an update to MDCG 2019-13 rev.1, the guidance document for the sampling of Class IIa…
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