Beyond Conception

In our last article, we discussed the confusing situation regarding remote audits and the strategies that manufacturers can follow in order to qualify for this type of inspection under the MDR. In this article we focus on analysing Notified Bodies’ experience while conducting remote audits under the MDD and giving you practical advice for successfully going through it and try to devise the future of remote audits.

Read our previous article here.‍

What do Notified Bodies think about remote audits?

In October 2020, the European Association Medical Devices of Notified Bodies (Team – NB) conducted a survey [1] where they showed that overall, the first remote audit experiences had been successful. They recognized that there are pros and cons to this approach, but in general their attitude has remained favourable.

Similarly, on another survey [8] made public by the end of last year they alerted of the great number of MDD and AIMD certificates that will expire in 2024. This number is greater than the sum of the certificates that will expire the previous three years, and does not even take into account new potential submissions. This means that a large amount of workload looms on the horizon for them, and they believe that remote audits can contribute to mitigate this problem.

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MDD and AIMD Certificates expiring in the following years

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Which are the main obstacles encountered by the Notified Bodies during remote audits?

Since the advantages of remote audits are clear for all of us (i.e, save up time and money, ease of involvement of more actors) I would like to focus on the challenges that lie in this new audit format and in some strategies to overcome them.

Surprisingly enough, the problems that Notified Bodies encountered most often are also the ones that are the easiest to remedy, namely:

→ Poor network connection (#1)

→ Manufacturer with limited IT skills (#2)

→ Excessive time in obtaining responses (#3).

These obstacles are easy to clear, as long as you are aware of them. Amidst the greatest pandemic the humanity has suffered in the last century, you should already be heading towards digitalisation, so this means problems #1 and #2 are probably under control. If you have not embarked in the process of digitalising your business yet, the perspective of remote audits may be the nudge you were waiting for. For problem #3, there are a number of solutions available. First, you can prepare in advance and scan documents that you foresee that may be requested during the audit. An alternative option is to invest in a document camera. These are non-expensive devices that can cut down on time spent scanning and sending documents to the auditor and ensure an easy-to-read content along the way.

If you are reading this article from outside Europe, it is very likely you need to consider another obstacle in the way: time difference. There is not much manufacturers can do about that, aside from reaching out to their Notified Body early on and negotiating the audit plan in advance.

By the way, do not be fooled into thinking that just because the audit will not be carried out on your premises you will be able to get away with it more easily. Notified bodies have reported to raise a similar number of non-conformities during these audits.

Number of non-conformities raised by Notiied Bodies during remote audits.

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The future of remote audits

As we have already discussed, there is a large number of certificates that will be in need of renewal soon. Extending this extraordinary measure in time would certainly help to mitigate the problem, as they make a more efficient use of the auditors’ time. Nevertheless, but not all actors have taken the same position. Some Member States are still reluctant to accept remote audits. In fact, in Commission Notice (2021/C8/01) it is implied that there is no unanimity on the decision:

As result, the potential need, in exceptional circumstances, to take temporary extraordinary measures, including remote audits, was recognised by the MDCG and supported by the vast majority of the Member States.

Likewise, the document also establishes that these measures shall “not go beyond what is required to ensure continuous availability of safe and performant devices, when concrete obstacles to complete conformity assessments on-site have been created by COVID-19 circumstances”.

Another indication of the tensions that this alternative to in-person visits has created became evident when Team NB recognized last February that they were unable to “finalize and publish its aligned position on the uniform implementation of such remote audits by Notified Bodies". Team-NB also wrote "The application of remote audits under MDR and IVDR due to pandemic-related contact and travel restrictions may currently vary across Member States depending on the governance provided by authorities”.

Eventhough it is clear that there is not a single position within the Member States, the doubts on the ability of the Notified Bodies to cope up with the high number of submissions in the near future and the current incidence rates in most EU countries still lead us to think that remote audits will be indispensable for the months and maybe years to come.

Do not hesitate to contact us at if you need assistance.

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