EN ISO 15189 and its Role in the IVD Regulation

April 22, 2024

ISO 15189:2022 is the latest version of the international standard that specifies the quality management system requirements particular to medical laboratories.¹ It was developed by the International Organisation for Standardization (ISO) and can be used by medical laboratories in developing their quality management systems and assessing their own competence. The new version of the standard was published in 2022 and includes technical revisions. EN ISO 15189:2022 is now also referenced in the Official Journal of the European Union.

The standard and the changes made that will impact labs can be reviewed in the standard document.

Both The American National Standards Institute and the Institute for Biomedical Science have written useful blogs that illustrate the key changes.

As we are entering the next phase of the IVDR on 26th of May 2024, additional conditions need to be adhered to for the implementation of Article 5(5) of the IVDR addressing the use of laboratory developed tests in health institutions such as having a Quality Management System (QMS) in place and EN ISO 15189 compliancy.² Reassuringly, labs that are already EN ISO 15189 compliant have solid foundations in place to build upon to support transition to IVDR compliance.³

^*Article 5(5) a: transfer of devices

^** Article 5(5) b: QMS, Article 5(5) c: EN ISO 15189 compliance or where applicable, national provisions, Article 5(5) e: Information to competent authority, Article 5(5) f: Public declaration, Article 5(5) g: documentation Class D (member states may extend to class A, B or C), Article 5(5) h: Manufacturing in accordance with point g, Article 5(5) i: Review clinical experience

^*** Including Article 5(5) d: Justification for use

Whether you work in a haemato-oncology, immunology or transfusion and transplantation lab, BD have one physically integrated workflow that will enable you to flow forward. We offer a complete integrated clinical flow cytometry solution that simplifies and automates processes, with traceability and electronic audit trails, helping to drive compliance, automation, standardisation and quality. Within our IVDR compliant portfolio of reagents, benefit from a broad and continuously expanding selection of single-colour and multi-colour IVDR compliant reagents. This complete solution can help to keep moving forward on your journey to IVDR.

Learn more about our IVDR compliant solutions

Resources available to support you

IVDR Brochure

For further information on how the BD solution can simplify your path to IVDR please click here

BD portfolio

The Biomedical Alliance in Europe IVDR task force who bring together expert panels across the industry and advocate for diagnostic labs have also collated useful resources

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. January 2023

European Commission Fact Sheet. Helping the transition to the new rules on medical devices and in vitro diagnostics 2024.

European Commission Fact Sheet for healthcare professionals and health institutions. Medical devices: change of legislation. What you need to know. 2020.

References

ISO 15189:2022. Medical laboratories. Requirements for quality and competence. https://www.iso.org/standard/76677.html
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Dombrink et al. Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force. HemaSphere (2022) 6:6(e724).

This document highlights only a few elements for consideration. Please refer to the complete IVDR (EU) 2017/746 document for full details.