Procorre urges Medical Devices industry to prepare for new ISO13485:2016 International Standard and MDD & IVD ‘Recast’

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in less than three years’ time.

Over the last six months, Procorre, which manages the life cycle of Medical Devices projects across the globe, has seen demand surge for guidance on the new regulatory changes as manufacturers and third-party suppliers start preparing for the transition to the new standard.

The ISO Standard and MD & IVD regulations have been introduced to ‘facilitate global alignment of appropriate regulatory requirements for quality management systems 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.

James Alexander, Director of Global Life Sciences at Procorre, said:

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. We’re already seeing demand rise for guidance on the regulations from organisations that are starting the process now, and we’re encouraging others to do the same.

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

• Incorporation or expansion of a risk-based approach to safety and performance of the Medical Device or IVD throughout the whole product lifecycle
• Increased linkage with regulatory requirements, and in particular, regulatory documentation
• Harmonising software validation for applications for QMS, process control, and monitoring and measurement
• Emphasis on infrastructure for orderly handling, production of sterile medical devices and validation of sterile barrier properties
• The obligation to have a person responsible for regulatory compliance available within the organisation (often called a QP – Qualified Person)
• Consideration in design and development of usability, use of standards, verification and validation planning, design transfer and design records
• Emphasis on complaints, reporting to regulatory authorities and consideration of post-market surveillance and Post Marketing Clinical Follow-up (PMCF)
• Planning, documenting and implementing corrective action and preventive action without undue delay

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.

Paul Rowden, Senior Director at European Device Solutions Ltd, said:

These 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 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. Either way, we’re encouraging organisations to take heed of the deadlines and start preparing 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.