Medical Device Compliance: 2025 Insights & 2026 Priorities
As 2025 ends and 2026 begins, medical device and IVD manufacturers continue to navigate an increasingly complex global regulatory environment…
Resources & News
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FDA Issues Updated Final eCopy Submission Guidance
The FDA issued an updated final guidance document titled “eCopy Program for Medical Device Submissions” on…
MDCG Master UDI-DI Timelines: Contact Lenses and Spectacles
The Medical Device Coordination Group (MDCG) has published MDCG 2025-7 Rev. 1 (December 2025), a position…
New EU Guidance on Breakthrough Devices & IVDs
In December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9, a new guidance document introducing…
MHRA Expands Regulatory Advice Access for Manufacturers
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated and expanded its regulatory advice service for medical devices…
EUDAMED and swissdamed Mandatory Registration Requirements
Mandatory registration in EUDAMED and swissdamed is finally here. By 28 May 2026, manufacturers marketing medical devices and IVDs in the EU must have completed their EUDAMED…
FDA Issues Technical Amendments to Align with QMSR
The U.S. Food and Drug Administration (FDA) has published a final rule implementing technical amendments across…
EU Confirms EUDAMED Functionality and 2026 Deadline
The European Commission has officially confirmed that several key electronic systems within the European Database on Medical Devices (EUDAMED) are…
FDA Regulatory Inspections and Audits
Preparing for regulatory authority (e.g. US FDA) inspections and Notified Body audits (for CE Marking) is a critical, ongoing process…
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