Not often in the past few years we have started a week with good news from the EU Commission but, much to our surprise, last week was one of those. An official notice was published to give the much-awaited green light to remote audits also for MDR assessments.
Early last year, the EU member states in the MDCG group had opened this possibility for audits under the directives and MDCG 2020-4 together with MDCG 2020-17 describe when and how these could be conducted. Now the COVID-19 situation has given the Commission the final push to accept this approach even for MDR and even for initial assessments.
The conditions required are largely the same, but with an important addition. Notified Bodies must conduct a risk assessment and provide a case-by-case justification for conducting the audit remotely. The reason for avoiding an onsite assessment will have to be related to the current pandemic and the duration of the period without onsite audits will have to be limited. In addition to all this, the Commission clarifies that Notified Bodies are permitted to derogate from the rule in order “to ensure continuous availability of safe and performant medical devices” and to “help prevent the risk of shortages” of devices. Meaning that for devices that can be placed on the market in the grace period based on MDD/AIMDD certificates, there will be little chance to provide a valid justification. On the other hand, if a sudden significant change is required to such a product, the MDR remote audit might be more realistic.
So, what should you practically do if you want your MDR audit to go ahead, despite the restrictions, as a remote audit? As always, different Notified Bodies are likely to have different processes in place, therefore there is not a standardised approach we can suggest. However, being proactive is always the most effective strategy and our recommendation is to get in touch with your Notified Body and formally present your case and your request. Do not ask what you should do but explain why the onsite audit is not possible, why you believe a remote audit does not introduce significant risks and why the audit should go ahead in order to guarantee availability of devices on the market. Basically, give them all the relevant information for conducting their risk assessment and justifying their decision. And if you need support for this, the wide team of Qserve consultants is here to help.
The publication of this notice is very good news for multiple reasons. First of all, it allows many initial MDR assessments to begin or be completed. It also makes Notified Bodies more efficient, at least for the (hopefully) short pandemic period. Although remote audits present some practical challenges, they certainly allow a more efficient use of the auditors’ time by cutting completely any travel time and this, by own admission of Notified Bodies, has been a significant advantage in 2020. And we all know how Notified Bodies’ capacity is and will be a key factor from now till at least 2024.
It is also good news because it means that the practice of remote audits, tested in 2020, has been effective, has not caused any serious concerns and has provided a good level of safety.
But when we talk about the MDR there is always a dark side. In this case not a particularly bad one, but bad enough to keep us on our toes. Within a document focused on remote audits, the Commission has added something interesting and slightly off-topic. A confirmation of their inability to foresee whether Notified Bodies will be able to cope with the amount of work that will be landing on their desks in the next few years. Although we all know this will be a problem, it is frankly quite eye-opening reading this clear and honest confirmation that the situation is not under control. If we want to keep an optimistic approach, we could say that at least it is the confirmation that the Commission is not in denial and is open to resort to some “extraordinary temporary measures” if needs be.
Not all good news but at least some good news…and in this period of MDR transition and pandemic it is probably the best we can hope for.