The impact of the new standard will have an impact on operating processes and will require more transparency relating to data management across most types of medical devices. ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard.
The standard is regarded by most global regulators as mandatory for the development and sale of medical devices. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. The latest standard was revised in 2016, and medical device companies have until March 1, 2019 to implement the full set of requirements.
In addition to the ISO standard revision there have been a set of new regulations from the European Union and from the U.S. Food and Drug Administration in the past two years. This leads to a complicated regulatory landscape.
The key aspects that medical device companies need to take account of include greater focus on product safety and performance. This extends to clinical evaluation and post-market clinical follow-up. It also requires improved traceability of devices through the supply chain.
Also included is the requirement for risk-based approaches beyond product realization; requirements for software validation for different software applications; and requirements relating to verification and validation planning, design transfer and design records.
Interviewed by MD&DI about the raft of changes, Andrew Tummon, who is the director of global clinical affairs at Integra LifeSciences Corporation, said: “By 2020, the device industry must show clinical evidence for the effectiveness and safety of both new and existing products—this means new clinical trials. The EU previously required a clinical evaluation report and literature review for many products. These reports involve the assessment and analysis of clinical data pertaining to the medical device to verify its clinical safety and performance.”
The impact will be, according to Tummon that companies will go through the difficult princess of working out which existing products are worth continuing to invest in. This is due to an anticipated increase in the scope and number of clinical studies.
For smaller medical device manufacturers, it is probable they will need to seek increased funding, given that many studies cost multi-million dollars. A further way to ease the impact is to move away from legacy paper-based systems and adopt new forms of technology, like cloud computing which permit data sharing.
