Guidance

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.

These are legally non-binding guidance documents, whose main purpose is ensuring uniformity in the application of the regulations

• Annex XVI products
• Borderline and Classification
• Class I Devices
• Clinical investigation and evaluation
• COVID-19
• Custom-Made Devices
• EUDAMED
• European Medical Device Nomenclature (EMDN)
• Implant cards
• In-house devices
• Authorised Representatives, Importers, Distributors
• In Vitro Diagnostic medical devices (IVD)
• New technologies
• Notified bodies
• Person responsible for regulatory compliance (PRRC)
• Post-Market Surveillance and Vigilance (PMSV)
• Standards
• Unique Device Identifier (UDI)
• Other topics
• Other guidance documents

Latest updates

• News announcement
• 26 July 2024

• 1 min read

• News announcement
• 9 July 2024

• 1 min read

• News announcement
• 22 February 2024

• 3 min read

• News announcement
• 6 December 2023

• 1 min read