News about medical devices

MDCG 2019-11 rev.1: What the New Version Changes for Medical and IVD Software

Medical devices regulation

MDCG 2019-11 rev.1: What the New Version Changes for Medical and IVD Software

New MDCG 2025-4 Guidance: Requirements for Medical Device Software Apps on Online Platforms

Medical devices regulation

New MDCG 2025-4 Guidance: Requirements for Medical Device Software Apps on Online Platforms

EUDAMED: Upcoming Obligations for Medical Device Manufacturers

Medical devices regulation

EUDAMED: Upcoming Obligations for Medical Device Manufacturers

EUDAMED v3.11.0 - What medical device manufacturers should know

Medical devices regulation

EUDAMED v3.11.0 - What medical device manufacturers should know

ISO 14971, ISO/TR 24971, IEC 60812 and IEC 61025: how to choose the right risk analysis methods for medical devices

Medical devices regulation

ISO 14971, ISO/TR 24971, IEC 60812 and IEC 61025: how to choose the right risk analysis methods for medical devices

🇪🇺 EMDN Update 2025: What Medical Device Manufacturers Need to Know

Medical devices regulation

🇪🇺 EMDN Update 2025: What Medical Device Manufacturers Need to Know

MDCG 2023-3 Rev.2: What Changes in Vigilance for MDs and IVDs in 2025?

Medical devices regulation

MDCG 2023-3 Rev.2: What Changes in Vigilance for MDs and IVDs in 2025?

Publication of Clinical Investigation Reports: The MDCG 2024-15 Guide Explained

Medical devices regulation

Publication of Clinical Investigation Reports: The MDCG 2024-15 Guide Explained

MDCG 2024-14: Making Sense of Master UDI-DI for Contact Lenses

Medical devices regulation

MDCG 2024-14: Making Sense of Master UDI-DI for Contact Lenses

MDCG 2023-3 Rev.1: New Vigilance Requirements for Medical Device and IVD Manufacturers

Medical devices regulation

MDCG 2023-3 Rev.1: New Vigilance Requirements for Medical Device and IVD Manufacturers

Q&A on Amendment 2024/1860 to MDR/IVDR: New Transparency and Safety Obligations for Medical Device Manufacturers

Medical devices regulation

Q&A on Amendment 2024/1860 to MDR/IVDR: New Transparency and Safety Obligations for Medical Device Manufacturers

MDCG 2022-5 revision 1 Guide: Clarification and Requirements for the Compliance of Medical Devices and Medicinal Products in Europe

Medical devices regulation

MDCG 2022-5 revision 1 Guide: Clarification and Requirements for the Compliance of Medical Devices and Medicinal Products in Europe

MDCG Guide 2024-13: What Medical Device Manufacturers Need to Know About Ethylene Oxide Sterilization

Medical devices regulation

MDCG Guide 2024-13: What Medical Device Manufacturers Need to Know About Ethylene Oxide Sterilization

Revision of the MDCG 2021-25 Guide: What Medical Device Manufacturers need to know

Medical devices regulation

Revision of the MDCG 2021-25 Guide: What Medical Device Manufacturers need to know

MDCG 2024-12: What It Means for Manufacturers in the Medical Device Industry

Medical devices regulation

MDCG 2024-12: What It Means for Manufacturers in the Medical Device Industry

New MDCG 2024-11 Guidance

Medical devices regulation

New MDCG 2024-11 Guidance

Complete Guide to MDR Codes: How to Use MDA, MDN, MDS, and MDT Codes for Medical Device Compliance

Medical devices regulation

Complete Guide to MDR Codes: How to Use MDA, MDN, MDS, and MDT Codes for Medical Device Compliance

MDR Documentation: Avoid Common Mistakes and Follow Best Practices

Medical devices regulation

MDR Documentation: Avoid Common Mistakes and Follow Best Practices

Annexes II and III of the MDR: How to Create a Technical File to Obtain CE Marking for Your Medical Devices

Medical devices regulation

Annexes II and III of the MDR: How to Create a Technical File to Obtain CE Marking for Your Medical Devices

New Regulation (UE) 2024/1860

Medical devices regulation

New Regulation (UE) 2024/1860