30 May 2023

General conditions the extension of the transition period

• Compliance with Directive 90/385/EEC or Directive 93/42/EEC.
• No significant changes in terms of design and intended use.
• No unacceptable risk to the health or safety of patients, users or third parties.
• 26 May 2024: implementation of a quality management system.
• 26 May 2024: application for certification.
• 26 September 2024: Notified Body and Manufacturer have signed agreement.

Devices with certificate or declaration of conformity issued before 26 May 2021

• 31 December 2027: high risk devices, i.e. Class III and Class IIb implantable devices, with exceptions.
• 31 December 2028: medium and low risk devices, i.e. Class IIb, Class IIa and Im, Is and Ir.
• 26 May 2026: custom Class III implantable devices.

Medical Devices with certificate or declaration of conformity expired before 20 March 2023

• Signature of the agreement between Manufacturer and Notified Body for MDR certification.
• Granting of an exemption by the Competent Authority to the Manufacturer.