Medical Device Manufacturers Urged to Prepare for New ISO13485:2016 and MDR & IVDR 'Recast' Deadlines

  • International Standard for Medical Device quality management revised for the first time since 2003
  • Manufacturers and third-party suppliers have less than three years to ensure products comply with both MD and IVD ‘Regulations’
  • Non-compliant products will be refused access to key markets including EU and US

Manufacturers and third-party suppliers of Medical Devices (MD) and In-Vitro Diagnostic devices (IVD) are being urged to prepare for the new ISO13485:2016 International Standard and MDD & IVDD ‘Recast’ which becomes mandatory in less than three years’ time.

The new ISO Standard and MD & IVD regulations have been introduced to ‘facilitate global alignment of appropriate regulatory requirements for Quality Management Systems (QMS) applicable to organisations involved in the whole life-cycle of a Medical Device’ (International Organisation for Standardisation - ISO). Both will reinforce safety and consistency throughout the medical profession and create a harmonised way for manufacturers to achieve the industry-recognised CE Marking approvals.

Products that do not comply with the new ISO13485:2016 Standard and MD & IVD regulations ahead of the fast-approaching deadline (28 February 2019) are likely to be refused access to key markets including the EU and US, which combined are worth $183.4 billion.

While the three year transition period seems to give plenty of time to introduce the necessary changes, the extent and implications of the changes are significant and it is expected to take between six and eighteen months to fully upgrade each manufacturers’ Quality Management Systems (QMS) and Technical Construction Files.

The revisions to the existing ISO Standard and regulations place greater emphasis on QMS and device usability.

However, the changes will significantly increase the administrative burden on organisations upgrading or replacing their MD or IVD devices, and it will take considerable time to revisit all Technical Construction Files and QMS documentation for devices currently on the market. Manufacturers and third-party suppliers also need to be aware that the changes will be different according to which sector they work in, so they’ll need to factor this into their planning.

We’re already seeing a significant rise in demand for guidance from those businesses already taking steps to get their houses in order, but we’re urging other organisations to take heed of the upcoming deadline and start their preparations in a timely and detailed way. Furthermore, most Notified Bodies are ‘imposing’ ongoing upgrades of their clients’ documentation throughout the whole three year transition period.

Procorre is working in partnership with European Device Solutions Ltd to help businesses transition their products to the new ISO13485:2016 and MD & IVD ‘Recast’ regulations. Businesses requiring guidance on the registration process for the whole CE marking process should visit our Medical Devices page.

Alternatively, download the White Paper for more information on the new ISO13485:2016 Standard and MD & IVD ‘Recast’ regulations: 

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