Virtual Audits under EU MDR – What You Need to Know

Virtual Audits under EU MDR – What You Need to Know


January 05, 2021


Veronika | Co-Founder & COO

With the COVID-19 pandemic and the consequent travel restrictions and remote working conditions faced by millions, medical device manufacturers are still expected to comply with quality system regulations and standards. This, of course, includes audits by Notified Bodies


The following article outlines why virtual audits have become necessary, how they work, what additional documentation medical device manufacturers can refer to and how manufacturers and Notified Bodies perceive the matter.

Why Remote Audits? 

Even under the extraordinary conditions we currently face around the globe, the availability of safe medical devices on the market must be guaranteed, as must the prevention of potential device shortages, which could be life-threatening for some patients. 


Therefore, in April 2020, the European Commission’s Medical Device Coordination Group (MDCG) announced that it would allow Notified Bodies to run “remote” or “virtual” audits in the face of the pandemic under specific circumstances. It is recommended that Notified Bodies decide whether a manufacturer is eligible on a case-by-case basis. 


In December 2020, the group published a Questions & Answers document with further information related to MDCG 2020-04. 


In January 2021, the European Commission published a further Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to Notified Bodies’ audits performed in the context of quality management system assessment. This notice focuses on legal requirements, the exceptional circumstances created by the COVID-19 pandemic and further considerations by the Commission.

How do Remote Audits work?

If a remote audit is permitted according to MDCG guidance, a Notified Body may make use of the technical means at their disposal to conduct a remote assessment. Among other things, Notified Bodies can conduct remote audits to:



Remote audits should be carried out using the most advanced available technologies while adhering to legislation on information security and data protection. Furthermore, when it comes to existing and new critical suppliers or subcontractors, remote audits under the Directives may be conducted using the principles and guidance outlined in MDCG 2020-4.


Some exceptions where remote audits should be avoided include:


Source: MDCG 2020-4


Furthermore, the full list of COVID-19 devices deemed essential by the European Commission, such as Personal Protective Equipment (PPE) or mechanical ventilators, can be found here


According to Martin Witte of TÜV SÜD, his Notified Body hasn’t seen a great difference when it comes to virtual audits, particularly in cases where there is already a well-established system already in place. Some limitations occur with regard to production, where any remote activities and inspections are, of course, limited. Other than that, however, remote audits for TÜV SÜD have gone quite smoothly so far. 


Nonetheless, the fact that Notified Bodies cannot carry out initial EU MDR audits in a remote setup is a huge obstacle according to Martin Witte. In these cases, they cannot rely on previous assessments, and must do everything on-site for the initial audit. So any current MDR projects are blocked by this.


Typical activities carried out during a remote audit

According to a recent survey by Team Notified Bodies, here are some of the main activities conducted by auditors: 



How are Remote Audits Perceived by Manufacturers and Notified Bodies?

Both manufacturers and Notified Bodies have expressed their support for remote audits in light of the pandemic and travel restrictions. In June 2020, MedTech Europe, the European trade association for the medical technology industry, published a position paper on “the need for ‘virtual audits’ under the Medical Device and In Vitro Diagnostic Regulations in the context of a pandemic, such as COVID-19”.


They urged the European Commission and Member States to publish guidance clarifying that, instead of on-site audits, Notified Bodies should be able to conduct audits under the EU MDR and IVDR in a virtual setting by using available technologies. They also stated that the scope of these virtual audits should not only be limited to COVID-19 related devices alone. 


According to MedTech Europe, remote audits would support manufacturers in their efforts to provide breakthrough technologies and solutions to patients while complying with current legislations. If clear guidelines and a clear risk-based approach are followed, remote audits can take place in a manner that maintains patient safety and device performance. 


Furthermore, the survey conducted by Team NB in October 2020 among 37 Notified Bodies shed some additional light on the authorities’ experiences when conducting virtual audits. Here are some of the results: 




While remote audits have their limitations, they represent a huge step forward for the healthcare industry and overall seem to be working quite well in the areas where they are permitted. 


COVID-19 has been a clear wake-up call for healthcare, showing that many processes are in dire need of a digital makeover. Virtual audits are an important component of this new digital era for MedTech companies and Notified Bodies, and could even prove useful once the travel restrictions have ended. 


The lack of Notified Bodies was already causing bottlenecks and now with COVID-19, actors are further blocked. With the EU MDR postponement, manufacturers won some time, but they should try to avoid backlogs mounting up before the new May 2021 deadline. It is also advisable to not work based on MDD or AIMDD, since these certificates will only be valid for three years and matters will be even more expensive for high-risk devices. 


Need to collect data on your medical devices in order to comply with the EU MDR? Contact us for a free demo or software trial

Veronika | Co-Founder & COO

Veronika | Co-Founder & COO


Passionate about digital health, sports, networking, and traveling. On a mission to excite healthcare professionals about the power of digital technologies to save time and money.

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