• News announcement
• 14 septiembre 2022

MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)

• News announcement
• 14 septiembre 2022

MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)

• News announcement
• 10 agosto 2022

MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies

• News announcement
• 5 agosto 2022

Call for EU reference laboratories sent to Member States

• News announcement
• 5 agosto 2022

Call for EU reference laboratories sent to Member States

Benchmarks for high-risk diagnostics

• News announcement
• 21 junio 2022

Setting the scene for EU reference labs for high-risk diagnostics

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU

• News announcement
• 24 mayo 2022

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

• News announcement
• 26 mayo 2021

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

Events

Publications