Virtual Medical Device Inspections and Audits: Here to Stay or a COVID-Era Blip?
Industry has a tendency to adapt quickly to changing market conditions, especially when money is involved. Government, not so much. When COVID hit the US in March 2020, in-person audits came to a screeching halt. Within months, when it became clear that the pandemic wasn’t disappearing anytime soon, medical device and IVD manufacturers pivoted and within a few months were conducting remote internal audits.
Still, regulators weren’t convinced about the benefits of this newfangled video technology thing. That’s finally beginning to change, or at least many in industry hope so.
FDA Sees Benefits in Doing Remote Medical Device Inspections
To be fair, FDA and European regulators had a lot on their plate dealing with emergency use authorizations during 2020. Much of their focus was aimed at getting more ventilators, treatments, and PPE safely on the market. FDA facility inspections took a back seat to pure pragmatism and necessity. Now, with the worst of the pandemic (hopefully) in the rear-view mirror, FDA is turning some attention to how to deal with a backlog of inspections that should have occurred in 2020 and into 2021. While no official program or guidance has been announced by FDA as of late February 2021, FDA does seem to be exploring the use of video meeting technology that has widely been used by industry for years.
In some areas FDA does seem to be testing remote technology to help do pre-assessments of regulatory risk. From their perspective, the goal is to get a baseline idea of a manufacturer’s compliance with FDA regulations so the backlog of future site inspections can be prioritized. This could be a good thing because it’s possible that a hybrid FDA inspection model may emerge in which the agency conducts remote desktop pre-assessments of compliance documentation and subsequently spends less time doing an onsite facility inspection. This would be more efficient for FDA and beneficial for manufacturers as well.
Despite the obvious efficiency benefits, it remains to be seen whether FDA will pursue this approach vigorously once the majority of people have been vaccinated and travel and in-person meetings are safe once again. It’s far more difficult for a large government agency to change course, and thus manufacturers should probably temper their expectations in this regard. However, given the FDA mandate to protect patient safety, they will certainly look for ways to do that using a risk-based approach, and remote auditing technology may help them inspect more medical device companies more efficiently.
European Commission Opens Door to Remote Audits…For Now
In Europe, the need to keep certification audits moving forward is driven by a specific deadline: May 26, 2021. That’s the date of application for the new Medical Device Regulation (EU MDR). Even before COVID hit, manufacturers were struggling to schedule recertification audits, but with the EU MDR date of application creeping ever closer, the European Commission issued a notice stating that European Notified Bodies will now be temporarily allowed to remotely audit their medical device and IVD clients and their suppliers. This comes on the heels of a December 2020 recommendation by the Medical Devices Coordination Group (MDCG 2020-17) to allow remote audits. Most Member States concurred with this recommendation after manufacturers and Notified Bodies pushed the issue, and the Commission finally agreed as well…with some caveats. Read this notice.
Going forward EU Notified Bodies may choose to offer remote audits but must:
1 – Limit their duration
No, they are not talking about the duration of the audit, but rather their frequency. The Commission clearly indicated that the ability to conduct remote audits is temporary and obviously brought on by extraordinary circumstances. As such, a “Notified Body’s decision on certification is limited to the time strictly necessary to allow for a proper on-site audit to take place as soon as possible.” This means that surveillance audits may happen at shorter intervals in the near term. You might be granted a remote audit in April and still have to get an onsite audit later in the year when most people have been vaccinated. Thus, don’t expect remote audits to become the “new normal.”
2 – Justify their use on a case-by-case basis
In short, remote audits are not automatic, and it’s not your call to demand a remote audit. The EC has clearly put the onus on Notified Bodies to evaluate each situation and document why an onsite audit is not possible. The EC states Notified Bodies should “not go beyond what is required to ensure continuous availability of safe and performant devices.” In doing so the Commission is clearly signaling that onsite audits are still very much preferred if practical, and if a remote audit is chosen, it must be justified in cases where “the inability to carry out such an on-site audit could prevent granting access or ensuring continued supply of devices to the market.” In some circumstances and conditions, such as the auditor is in the same country, region, or even city, then onsite audits may still proceed. What this ultimately means is that your Notified Body might not grant you a remote audit unless you can prove a potential disruption of supply or the circumstances make an onsite audit unsafe or impractical (example: auditor coming from another country or region). Start building your case.
This notice was issued on January 11, 2021, and it closes by “inviting” Member States (countries) to submit information on how they will comply with these “temporary extraordinary measures” along with an estimate of how long they will leave them in place. Like everything else related to COVID, the situation is fluid, so we recommend that you contact your Notified Body for more information.
How to Prepare for a Remote Medical Device Audit
Whether you are a participant in a remote internal audit or the subject of an audit or inspection by a regulator, there are certain things you really need to do to ensure that your virtual experience doesn’t turn into a live fiasco. You can read our excellent article on how to prepare for remote audit, but in summary here are some questions and issues you really need to consider:
- Are most of your RA/QA documents and records maintained digitally? Which are not?
- Do your employees have remote access to the systems where documents and records are stored electronically?
- Does your company have confidentiality policies that would limit your ability to share documents and records electronically, either as files or via online meetings?
- Will the scope of the audit require a review of your manufacturing operations in process or certain areas of your facility?
- How will you use video for certain aspects of the inspection? For example, are you going to use your iPhone to walk around the facility as the inspector asks questions?
- How are the cellular or Wi-Fi signals in various spots you might be during an audit? It may work great near your desk, but does it work when you walk out onto the plant floor?
- Do you have a checklist prepared that will allow you to make sure you’re prepared for all the different things that might come up during a remote audit?
- Have you considered who will be interviewed during the audit or how data will be securely shared?
These are just some of the myriad issues you really need to think about before participating in a remote virtual audit or inspection. As we have all experienced at one point or another, technological hiccups can quickly derail a meeting and fluster the participants. Take that stress out of the equation by doing a test run and preparing appropriately.
Want to Learn More?
Oriel STAT A MATRIX has been helping medical device and IVD companies since 1968. We have trained more than 130,000 auditors and helped hundreds of companies with ISO 13485, FDA QSR, MDSAP, and more. If you want to learn more about how to properly conduct a medical device audit, consider this remote audit training class. If you need someone to do those audits for you, our team is ready to help.