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The revised version of the widely used ISO 13485 Medical Device Quality Management System standard has been released on 25 February 2016

Posted on 07.04.2016

Besides the EU, it provides compliance in Canada, Japan, Australia for quality management systems of medical device manufacturers. The standard is also one of the pillars of the Medical Device Single Audit Program run by International Medical Device Regulators Forum.

The updated version of the standard is expected to be harmonized under the three European Medical Device Directives.

CEN/Cenelec is going to propose a 3-year transition (until 31 March 2019) when offering the standard for harmonization to the Commission (which should happen by early May 2016).

Manufacturers need to plan their transitioning incorporating the novelties of the updated standard into their QM system.

Some of the biggest changes between the 2003 and 2016 version include:

  • Incorporation of risk-based approaches beyond manufacturing. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements;
  • Increased bond with regulatory requirements, particularly for regulatory documentation;
  • Broadened application of the standard by including all organizations involved in the life cycle of the product (from development, production, storage, distribution/supply chain, installation to maintenance/ services of medical devices);
  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard;
  • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices;
  • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records;
  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance; and
  • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay

For a more comprehensive comparison of the 2003 and 2016 versions, please consult the Annex A of the published ISO 13485:2016 standard.