The IVDR date of application is here, are you ready?
IVDR Implementation timeline
Today introduces the (EU) 2017/746 (IVDR) date of application bring in a new age of regulation for the precision medicine industry. From 26th May 2022, IVDR will implement a change in existing in vitro and companion diagnostic medical devices having to comply with new standards and regulations. ARC have been working closely with EU national competent authorities to obtain clarification on key points within the IVDR.
26th May 2022 - IVDR Date of Application, new and existing CE-marked IVDs with substantial changes will need to comply with the requirements of the IVDR. Performance studies will need to comply with the requirements of Articles 55 to 77, Annex XIII and Annex XIV as applicable. Existing CE-marked IVDs will need to adhere to the post-market surveillance, market surveillance, vigilance and registration of economic operators under the IVDR.
26th May 2024- Majority of Article 5.5 (In-House Exemption) (b),(c),(e) to (i) comes into force. Noting the following requirements:
(b) Requiring that organisations establish, document, implement, maintain, keep up to date and continually improve a Quality Management System that is proportionate to the risk class and type of device.
(c) Ensuring compliance with EN ISO 15189 or other national provisions.
(e) For organisations to provide information to a competent authorities if requested.
(f) Publicly available declaration of conformity
(g) Stricter requirements for class D IVDs.
(h) Devices are manufactured in accordance with (g)
(i) Ensuring that organisations evaluate the experience gained from clinical use and taking any necessary corrective actions if required.
26th May 2025 - The end of transitional period applies for self certified Class D In-Vitro devices.
27th May 2025 - Certificates for IVDD devices issued by notified bodies may no longer be valid.
26th May 2026 - The end of transitional period for self certified Class C In-Vitro and companion diagnostic devices.
26th May 2027 - The end of transitional period for self certified Class B and Class A sterile In-Vitro diagnostic devices.
26th May 2028 - The fulfilment of Article 5.5(d) comes into force where Health Institutions need to provide justification that patient groups specific needs cannot be met at the appropriate level of performance by an equivalent device available on the market.
Keep up to date on IVDR developments
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Article written by ARC Insights
May 26, 2023
ARC Insights offers a mix of industry specific content with the aim to keep its readers informed, educated, and up to date with the latest developments, trends, and expert knowledge in the FiH translational medicine space.
