Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
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- MHRA Registration of medical devices
- The Use of Data in Public Health. Understanding the Potential for Artificial Intelligence in Medicine
- UK Government confirms indefinite recognition of CE marked medical devices
- Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
- Good manufacturing practice (GMP) Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)
- PIC/S PE 009-18 – Guide to GMP for Medicinal Products | Part I
- EMA Updates Information Page on Bioequivalence Guidelines

