News about GMP/cGMP


US experts call for early preparation for European MDR, IVDR and what about 21 CFR 820?

At the International Conference on Medical Device Standards and Regulations in Arlington VA, hosted by the AAMI (Association for Advancement of Medical Instrumentation), experts discussed the upcoming regulatory changes occurring with the new European regulations on medical devices (MDs) and in vitro diagnostics (IVDs). They urged the companies to prepare for these changes because it is likely that the medical device industry needs to invest a lot of time and resources to prepare for and comply with the upcoming requirements when it comes to trading goods with the European industry or manufacturing in the EU.

AAMI is a US-based non-profit organisation with a community of approximately 7,000 experts examining the development, management and use of safe and effective health technology.

What was discussed?

Some of the major changes that will come from the European regulations on medical devices and in vitro diagnostics are the greater role of notified bodies (NBs), the risk-based classifications as well as an intensified clinical evidence definition.

In preparation for IVDR, Ian Purdy from Haemonetics, a blood and plasma supplier, says: “No matter what numbers you look at, there’s going to be a lot less NBs.” According to him, one solution for the industry is to select and have a continually available NB. He also explained that communicating to senior management may be useful. It should be clarified that an investment in training for personnel that is in contact with regulatory compliance is very important. He also urged the companies to gather as much data as possible. “Fix this now because every bit of data that comes in is going to help you over time.”
Especially when it comes to the "no grandfathering” rule, meaning that all existing devices need to comply with the new regulations by the end of the transition phase in 2020 for MDs and 2022 for IVDs, this could be really helpful.

What about 21 CFR 820?

Not only AAMI is calling their members to plan ahead. The US FDA is also addressing the topic. The AAMI published a press release on its website which summarised a speech of Keisha Thomas, FDA, held at the International Conference on Medical Device Standards and Regulations Conference in Arlington:

The Food and Drug Administration shows a strong interest in changing its quality system requirements for medical device manufacturers and utilise the International Organisation for Standardization (ISO) updated quality management standard, 13485:2016... An initial gap analysis between 21 CFR 820 and ISO 13485:2016 is already performed and a technical information report will be compiled."

So, does this mean that the Quality System Regulation 21 CFR 820 could be going away? Maybe and maybe not. Keisha Thomas said:

I don’t have the full-on answer … about whether 820 will be absorbed and how these two will integrate or if there will be an integration at all. What I will tell you is that we see the utility in the move toward global harmonization, and we are exploring all options in considering how we can do that. You will have to stay tuned for a final decision because one has not come out from the agency yet, but it will be coming out in the late spring in a very public notification.

One thing Thomas was certain about was that there would not be a “dual quality management set of requirements“. "The agency is not at all interested in managing multiple quality management system requirements,” she said.


AAMI, Press Release