Important IVDR timelines

During a transition period some ivd devices (98/79/EC: legacy devices) may continue to be sold on the Union market. To benefit from this extended transition period, certain conditions have to be met (IVDR Art. 110) e.g.:

• • IVDD Declaration of Conformity signed before 2022-05-26. We understand that minor changes often need to be made to DoCs to keep them up to date with the product file; however, under the requirements of CIBG (Dutch Competent Authority) and other Authorities, the original DoC cannot be changed after the date of application of the IVDR (2022-05-26). All non-significant changes can be captured in an amendment to the Declaration of Conformity.
• • Involvement of a Notified Body;
• • Devices continue to comply with Directive 98/79/EC;
• • There are no significant changes in the design and intended purpose;
• • The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
• • The manufacturer has put in place a quality management system in accordance with IVDR Article 10(8);
• • Post-market surveillance, market surveillance, vigilance, and the registration of economic operators and of devices shall apply to devices, as set out in the IVDR.

You may continue to sell Directive compliant devices, if above conditions are met. To benefit from this extended transition period, the manufacturer has to draw up a manufacturer self-declaration, in which he states that the conditions are met.

• • Medtech Europe as published this template for self-declaration: Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860 – MedTech Europe
• • Additional guidance you may find here: Q&A Extension of the IVDR transitional periods
• • Optionally you may also request a NB-statement from your NB, according following template: Template for notified body confirmation letter