The Medical Device Regulation (Regulation EU 2017/745), or MDR if you like abbreviations, is still planned to come into application on 26 May 2021 (check out the article on the MDR implementation timeline I wrote a few weeks ago). Given the exceptional circumstances caused by the global COVID-19 pandemic, the European Commission has released a notice on 11 January to make provision for remote audits on a temporary basis. In this brief article, I will briefly explain this Commission notice.
The first section of the notice is the legal requirements of the MDR. As I've explained in previous articles, the MDR is a legal document applicable at the Union level (this means that all European Union countries are affected) and that is applicable for various entities, including notified bodies (NBs). The MDR requires that medical device manufacturers put in place a quality management system (QMS) before placing any device on the market (see Article 52 and Section 2.3 of Annex IX of MDR). The QMS is then assessed by a third party, such as an NB, through surveillance audits and conformity assessments. Typically, surveillance audits are undertaken at the manufacturer's premises, or "on-site", on a periodic basis (e.g. every 12 months). The MDR requires that NBs be monitored by national authorities to ensure continuous compliance (see Article 44 of MDR). Furthermore, these national authorities may take the necessary penal actions when they have sufficient proof that the NBs are failing to meet the MDR requirements (see Article 46 and Article 113 of MDR).
Since surveillance audits require the NB to be present at the manufacturer's premises, it is hopefully clear that the majority of NBs would be failing to meet this requirement alone, given the various COVID-19 restrictions that prohibit non-essential movement and gatherings. The next section breaks down the effect of COVID-19 in applying the MDR for audits.
The exceptional circumstances in the context of the COVID-19 pandemic
The second section of the notice highlights the implications of COVID-19 for on-site audits. Various stakeholders have made it known to the European Commission that COVID-19 restrictions had made it impossible/impractical to perform on-site audits. In addition to this, the short-term forecast of the pandemic means that new measures have to be put in place temporarily to ensure that surveillance audits continue to take place, in light of the fast-approaching 26 May 2021 deadline.
Considerations by the Commission
The European Commission has ultimately decided to recall the requirements imposed by the MDR to punish NBs that fail to perform on-site audits at manufacturers' premises. This decision, of course, is made due to the following key factors: the unforeseen and exceptional COVID-19 circumstances; the increased need to ensure safe medical devices are placed on the market, especially if those devices are critical to the management of COVID-19 and; remote audits performed under the Medical Devices Directives have demonstrated an adequate degree of safety and reliability. However, this recall of requirements is not permanent and is by no means a free pass. Remote audits are a temporary alternative that the Commission will monitor regularly until on-site audits are possible again.
It was only a matter of time that such a notice would be established. Over the course of the approximately past 12 months, we have seen the world shift to "working from home" and remote business operations. It is, therefore, no surprise, at least not for me, that MDR remote audits are now possible. This big decision is welcomed and certainly serves as a glimmer of hope to what has been a quite confusing transition from the Medical Devices Directives. I probably sound like a broken record by now, but this notice brings to light the thoughts that I have been presenting regarding digitizing your QMS. My take is that remote audits will eventually be an acceptable permanent form of conformity assessment. This means that your documentation system has to be smart, fast, and effective. The success of these audits will rely partly on how easily your auditor can access and navigate through your technical documentation. While you may not be worried about MDR, for now, it's important to stay on top of things and make your QMS as effective and smart as possible.
Infomed Consulting would love to support you in making your system more effective. Contact us for more information.