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Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
The European Commission published guidelines to assist providers and deployers of artificial intelligence (AI) systems in meeting the AI Act's transparency obligations, which start to apply on 2 August 2026. Transparency obligations will help people recognise when...
MDCG Position Paper: UDI assignment between manufacturers and distributors
This MDCG Position Paper aims at explaining the point to clarify the situation and avoid confusion, misunderstandings or potential misuse arising from differing interpretations between manufacturers and distributors, as well as the EU UDI issuing entities. This should...
EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
This guidance document addresses a number of questions which stakeholders, in particular the marketing authorisation holders (MAHs)/applicants, may have on an Article 31 non-pharmacovigilance referral procedure. It provides an overview of the European Medicines...
EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices REV. 2. JULY 2024
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