In June 2025, the FDA released a white paper emphasizing the need for stronger cybersecurity in medical product manufacturing, specifically focusing on Operational Technology (OT). The paper, titled “Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing,” highlights how increased connectivity in manufacturing environments can create vulnerabilities if cybersecurity isn’t prioritized. The FDA urges manufacturers to adopt state-of-the-art cybersecurity practices for OT to reduce the risk of cyber incidents and ensure the safety and reliability of medical products.
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- Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
- MDCG Position Paper: UDI assignment between manufacturers and distributors
- EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
- EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
- MHRA Updated guidance for the International Recognition Procedure (IRP)
- MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
- Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
- FDA Guidance for Drug Development