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ISO 13485:2016, the Medical Device Regulation and the IVD Regulation - Are they aligned?

The medical device industry is undergoing a period of immense change. In 2016, there has been a new version of the ISO standard for the medical device industry, ISO 13485, as well as two new Regulations, for medical devices (including active implantable medical devices) and for in-vitro diagnostic devices. The changes require thorough understanding of the new requirements, and robust, efficient plans to ensure that all new requirements are met within the relevant transition periods.

ISO 13485 has a three year transition period, ending on 28th February, 2019.

The Medical Device Regulation (MDR) will have a three year transition period from the date of adoption.

The In Vitro Diagnostic Regulation (IVDR) will have a five year transition period from the date of adoption.

Meeting the requirements of ISO 13485:2016 can help manufacturers to meet the MDR and IVDR requirements for implementing a Quality Management System (QMS), with conformity to the accepted harmonized standard being an acceptable demonstration for the purposes of the Regulations. ISO 13485:2016 and the MDR and IVDR have specific requirements of their own for the QMS, which must be individually adhered to in order to receive certification.

For example, as well as an increased focus on risk management, verification and validation in the new standard, there has been better alignment between the requirements of the standard and the Regulations.

This webinar will discuss the areas of alignment between ISO 13485:2016 and the MDR and IVDR, allowing you to plan an efficient transition to ISO 13485:2016 and the new Regulations.


Stewart Brain is the QMS Certification Lead at BSI Medical Devices and has worked in the BSI Medical Devices Notified Body for 15 years. He has overall responsibility for the management of BSI's UKAS accredited ISO 13485 quality system certification programme. Prior to this he was the Global Head of Microbiology for 10 years where he had overall responsibility for the microbiology and sterilization assessment work carried out by BSI.

Linda Moon is an IVD Product Specialist in Healthcare at BSI. Her key roles are assessing clients to ISO13485, CMDCAS, IVD and MDD quality systems management and ISO 9001. Linda also delivers training courses: predominantly ISO13485, internal auditor and the IVD courses.