What are the key regulatory changes on the horizon?
Kim Trautman: The new EU MDR, as well as its subsequent IVD regulation, are coming into effect in Europe in 2020 and 2022 respectively. I like to describe the changes as pertaining to five categories: clinical; usability; risk management; labelling; and post-market surveillance.
One of the key aspects of the new requirements for a risk management system, according to the third edition ISO 14971:2019 and Regulation (EU) 2017/745, is the newly defined technical documentation needed to include increased expectations for risk management data throughout the medical device life cycle. The new ISO14971:2019 can assist.
Risk management plays an instrumental role in complying with regulatory expectation for medical devices or in-vitro diagnostics. Risk management processes for maintaining and continually updating benefit and risk data start early in design and development to include clinical evaluation, through to active post-market surveillance.
What are the key regulatory compliance challenges that manufacturers face?
What manufacturers are finding is that they may not have the right data sets. Early in the design phase, people are often collecting information for a variety of regulatory purposes – they have to show safety, effectiveness and performance data. However, sometimes they don't have the foresight in their protocols to consider how they are going to be able to collect data in the post-market phase.
The other challenge is that this data is captured in several different places throughout the organisation, whether that is a big or a small manufacturer. Often those different data sources are owned by different parts of the company. Some data is owned by clinical, some by marketing, some by regulatory, some by quality, etc. Larger manufacturers may have more difficulty because the roles and responsibilities for how certain data is collected may be across different people.
It is very important to understand that in order to handle all the different data sources that provide information on benefit/risk and clinical performance, there must be planned and concerted integration – there has to be inter-department teams working together.
What services does NSF offer to help companies needing more guidance?
We are assisting our clients with gathering data, remediations by implementing process and procedural changes, and performing technical assistance in a variety of ways. We are running implementation workshops, since classroom training has already taken place. We also perform mock audits to ensure that processes and procedures meet the new requirements. We continue to assess for gaps in those processes; especially as it is related to integration across functional areas.
Many companies have been working on these new requirements for a couple of years. Clients have broken up work into different teams and groups to do certain tasks. Now it is a case of ensuring that all those different teams talk to each other. We go in and help them integrate those activities across the different silos.
Besides working directly with manufacturers to change and update their processes, we also continue to perform clinical evaluation reports. We do mock technical documentation review with remediation assistance, mock assessments of client's plan for regulatory compliance, and regulatory strategies for persons responsible for regualtory compliance (PRRC). We have teams in the US, UK, France and Germany, all working to assist our clients with these new regulatory expections and quality system updates.
