Following the IVDR article 78(2), throughout the product lifetime, we’re required to systematically gather, record, and analyze relevant data on the quality, performance, and safety of a device to draw necessary conclusions and to determine and implement and monitor any preventative and corrective actions.
Under article 78, it tells us that the PMS data is used to:
- Update Benefit Risk Determination & Improve Risk Management
- Update Design & Manufacturing Information, IFU & Regulatory Labelling
- Update Performance Evaluation
- Update Summary of Safety & Performance
- Identify need for Preventative, Corrective or Field Safety Corrective Action
- Identify Improvements to Usability, Performance & Safety
- Contribute to PMS of Other Devices
- Detect & Report Trends
Now, for many of you, a lot of these things in here will be very familiar. There are things here that we as an industry have done for a long time. Some of the items in here are also new. For example, updating the benefit risk determination and risk management is something that would normally happen under the ISO 14971 risk management.
Updating design and manufacturing information, labeling, IFUs, etc and identifying improvements to usability, performance, and safety are things that would normally be expected to happen under a current post market surveillance process.
Updating the need for corrective and preventative action and field safety corrective action would be functions of a CAPA process and a vigilance process. Detecting reports and trends are something that should be familiar to people under MDDEV 2.12-1 for many years.
But we also have some new items in here. For example, the performance evaluation is a new deliverable under IVDR, as is the summary of safety and performance. Then we have this specific requirement to contribute to the post market surveillance of the devices. Many companies will have already been doing that within a similar portfolio already, but it is a specific requirement under the regulation.
Moving on, I’d like to talk about PMS in the context of a transition from IVDD to IVDR. As we go through the transition of the technical file, a product from IVDD to IVDR, we will go through several sections.
Firstly, we’ll look at having an essential requirements checklist under Annex 1 of the IVD. That will require a detailed gap analysis to convert to the general safety and performance requirements and a checklist for that under IVDR.
Similarly, the structure of the technical file under IVDD is somewhat different from the structure of the technical documentation under IVDR. Therefore, there will need to be a rest of that to meet the IVDR requirements. In that review of the essential comments in terms of general safety performance requirements, additional technical and scientific data likely needs to be identified as needed to address gaps between the IVDD and the IVDR requirements.
That data is then going to end up in the performance evaluation report, which will become an input into both ANNEX I and ANNEX II under the technical documentation.
Looking into the post-market surveillance requirements. We had post-market surveillance under IVDD. Under IVDR, the post market surveillance process is prescribed in detail. A new process will be required to be developed and put in place in order to meet the requirements under IVDR for ANNEX III. Then in running that process, that will then have an impact upon the performance evaluation report. It will update the performance evaluation report, which we’ve talked about, is required to demonstrate compliance under the general safety performance requirements.
One of the questions we need to ask ourselves as we go through this process is, how good is our existing post-market surveillance and if it’s not at a sufficient level, do you need to run that process as an input to your performance evaluation for the first time? And if that’s the case, that means that all that process has to be in place and has to run in order to provide that input, which is important for scheduling a project.
We have new deliverables under IVDR for post-market surveillance requiring new procedures or updated procedures to create them. So, we need to create the procedures first, run the procedures, and produce those new deliverables.
Post Market Surveillance Procedures
- Post Market Surveillance Plan
- Post Market Performance Follow Up Plan
- Post Market Performance Follow Up Report
- Periodic Safety Update Report
- Summary of Safety & Performance
New deliverables under performance evaluation procedures, which is a new structure of work under the IVDR.
Performance Evaluation Procedures
- Performance Evaluation Plan
- Scientific Validity, Analytical Performance and Clinical Performance Reports
- Performance Evaluation Report
All of these reports will then be fed into a clinical evaluation report.