Notified bodies report success — and some drawbacks — using remote audits

Regulatory NewsRegulatory News | 04 August 2021 |  By 

Remote audits conducted by notified bodies have been successful in ensuring that medical device manufacturers are complying with the EU’s Medical Device Regulation and In Vitro Diagnostics Regulation, according to a recently conducted survey of 46 notified bodies, with remote audits uncovering roughly the same number of deficiencies as onsite audits.
The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB), located in Liège, Belgium, to gauge notified body assessment of the success remote audits. The survey was returned by 88% of the 52 notified bodies who received it via EUSurvey, the survey tool of the European Commission (EC).
More than 33,000 audit days were covered by the survey, with just 337 related to regulations. The remainder of the audit days related to directives.
Almost all respondents called remote audits “generally,” “very,” or “moderately” successful; only three deemed them “generally unsuccessful” in monitoring compliance with the regulations.
These responses are on par with a similar TEAM NB survey conducted in late 2020; at that time, 75% of the notified bodies reported success using remote auditing.
The majority of respondents (86%) in the most recent survey said the outcomes of remote assessments were “more or less equivalent” in identifying non-conformities compared to on-site audits.
Notified bodies cited some of the benefits of remote audits, including less need for travel and   allowing for a “tight focus.” These audits are also an effective tool for auditing non-physical processes like software and the quality management system, as well as verifying the quality of the records. Respondents also said that remote audits are “more successful with established customers.”
However, respondents also found some drawbacks with remote audits. Disadvantages were primarily related to the nature of electronic teleconferencing, with respondents citing issues that arise with significant time differences and faulty internet connections. Respondents also pointed out that video access to a facility is no replacement for the level of inspection that’s possible with human eyes onsite and noted lack of spontaneity in reacting to issues detected.
Respondents also say that some provisions in the MDR and IVDR regulations are not amenable to remote audits. These include clauses relating to auditing the infrastructure, the work environment, contamination control, product and service provisions, monitoring and measuring equipment and handling nonconforming product.
Notified bodies also report that a majority of remote audits (58%) have not been witnessed by an accreditation body or a designating authority. For those that have been witnessed, auditors have been “praised for good preparation and time keeping,” while others said more auditing time was needed. Some also commented that “the observers' presence seems to be less noticeable and therefore less intimidating to the audit team and the auditee.”
The European Commission’s Medical Device Coordination Group (MDCG) released a questions and answers document in December 2020 clarifying expectations for notified bodies looking to conduct remote audit of medical device manufacturers during the COVID-19 pandemic. (RELATED: MDCG clarifies remote audit expectations for notified bodies, Regulatory Focus, 4 December 2020)
Notified body survey on remote audits


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