MDCG 2022-6 guidance on Significant Changes to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a few weeks ago.
IVD legacy: what are the “significant changes”?
First, it is important to clarify that legacy IVDs are all those devices covered by a valid certificate in accordance with Directive 98/79/EC (IVDD) and which, according to Article 110 (3) may continue to be legally placed on the market after 26 May 2022 provided that no significant changes are made in the design and intended use of the devices.
This “Period of Grace” does not apply to those CE marked IVD devices which do not require the intervention of a Certified Body (non-sterile IVD class A) and which therefore must demonstrate their fully compliance with the IVDR starting from 26 May 2022.
In its essence, MDCG Guideline 2022-6 provides valuable help in the interpretation and verification of the “significant changes” pursuant to Article 110.3 of IVDR (EU) 2017/746.
“Significant changes” refer to product or process changes that impact the design and intended use of the device. The significant changes, pursuant to art.110 must be communicated to the Notified Body and entail the forfeiture of the IVDD Period of Grace certificate with the consequent need to issue an IVDR certificate.
To help manufacturers understand if a change can be considered as significant, the MDCG 2022-6 provides several flow charts that take into account changes to the device in many applications (intended use, design, software, formulation and sterilisation).
Other harmonised IVDR standards published
The European Commission, with the Commission Implementing Decision (EU) 2022/729 of last 11 May 2022, has formalized other harmonised standards IVDR (EU) 2017/746 for In Vitro Diagnostic Medical Devices.
Standards for quality management and risk management have now been added to the harmonised IVDR standards already published in July 2021 and January 2022:
- EN ISO 13485:2016, with amendment A11:2021 and rectification AC:2018
Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes (ISO 13485:2016)
- EN ISO 14971:2019, with amendment A11:2021
Medical Devices – Application of Medical Device Risk Management (ISO 14971:2019)
The harmonized IVDR standards are effective from the publication and their application to the device (and presence in the documentation) is required by the Notified Body in the IVDR certification phase.
Do you need support to comply with IVDR (EU) 2017/746?
Through our strategic-regulatory consulting services, Thema professionals can support you in fulfilling the requirements of the Medical-Diagnostic Devices in Vitro Regulation.
IVDR Emergency Kit is also available: it provides templates and standard technical documents to comply, mainly acting independently, with the main obligations of the IVDR.
Contact our Customer Service for more information!