As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document, implement, maintain, keep up to date and continually improve a quality management system (QMS)”. Setting up a QMS is not precisely an easy task, and it requires the commitment of top management and the assignation of plenty of resources. Because of that, we have created here a helpful article to support manufacturers understanding QMS requirements in compliance with the EU regulations and ISO 13485.
Where to start? MDR and IVDR requirements
Starting with the basics, the QMS is a structured system that documents processes and responsibilities for planning and executing quality objectives and policies. A QMS allows organisations to coordinate and direct their activities to meet regulatory and customer requirements and continuously improve their effectiveness and efficiency.
The implementation and maintenance of a QMS are requisites to place medical devices and in vitro diagnostic medical devices (IVDs) in the EU market according to the MDR (EU Medical Device Regulation 2017/745) and IVDR (EU IVD Regulation 2017/746) respectively. Articles 10 and Annexes IX of each regulation list the minimum aspects that the QMS should address. In addition, manufacturers can rely on the internationally recognised standard ISO 13485:2016 to set up their QMS. Following it, though not mandatory, will ensure compliance with the QMS requisites outlined in the MDR and IVDR.
Certifying your QMS: the role of Accredited Certification Bodies and EU Notified Bodies
ISO 13485 certification can only be certified by Accredited Certification Bodies. The list of approved certified bodies for ISO certificates, including ISO 13485, can be found on the International Accreditation Forum (IAF) website.
Manufacturers looking to CE-mark their product in the EU may require the involvement of a designated notified body depending on the risk classification of the device. In such cases, the notified body will be responsible for assessing and (re-)certifying manufacturer’s conformity with EU regulations. The conformity assessment procedure generally includes the audit of both the Technical Documentation and the QMS; for this reason, designated notified bodies are also accredited certification bodies for ISO 13485.
For manufacturers that first want to place their device in the EU market, it might be a good strategy to select a body that is accredited for both ISO 13485 (accredited certification body) and conformity assessment with the MDR/IVDR (notified body). The list of designated notified bodies is available in the NANDO database
ISO 13485 is the principal and most international QMS standard for the medical device industry, being followed worldwide, including in Europe. Its latest and current version is ISO 13485:2016, which has been harmonised by the European Commission (EN ISO 13485:2016). The standard is not mandatory, but compliance is highly recommended and creates a presumption of conformity with EU regulations.
How can AKRN help?
AKRN support medical device manufacturers and other organisations in developing and implementing a QMS under ISO 13485:2016 and compliant with EU regulations. Our services include:
- Development of QMS documentation according to ISO 13485:2016
- Full implementation of QMS according to ISO 13485:2016
- Internal audits according to ISO 13485:2016
- Gap assessments with prior ISO 13485 versions and EU requirements
- Assistance in resolving gaps identified.
Contact us and let us guide you through this path to achieve all your goals!
About the authors
Albert Negrete Hurtado, Ph.D. Regulatory Affairs Scientist
Ariadna Navarro Aragall, Ph.D. Associate Director Quality & Regulatory Affairs