[co-author: Silvia López Arnao]
On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and Regulation 2017/746 of the of 5 April 2017 on in vitro diagnostic medical devices (IVDR) may be performed. The European Commission recalls that this is a temporary extraordinary measure motivated by the unprecedented circumstances that the medical devices industry is experiencing due to COVID-19. The possibility of conducting remote audits will, therefore, be assessed on a case-by-case basis and will only be allowed until on-site audits are again possible.
Background for the Notice
The European Commission’s Notice follows the high demand by EU Member States, notified bodies, and other stakeholders on the possibility to conduct remote audits under the MDR and IVDR. The Medical Devices Coordination Group (MDCG) had already discussed in its meetings in October and December 2020 the potential risks related to inability for notified bodies to carry out conformity assessment activities in the context of COVID-19 circumstances.
The Notice provides that the current epidemiological indicators for COVID-19 in the EU and around the world justify the adoption of temporary extraordinary measures in specific cases when the impossibility for notified bodies to conduct on-site audits could raise the risk of shortages of vital medical devices.
Considerations raised by the European Commission
The European Commission provides the following considerations for the conduct of remote audits for assessments performed under the MDR and IVDR:
- They must be limited in duration, this means that any notified body’s decision on certification is limited to the time strictly necessary to allow for a proper on-site audit to take place as soon as possible;
- They must be identified and justified on a case-by-case basis, and the individual circumstances must be documented and duly substantiated by the notified body; and
- They must 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.
The national authorities responsible for notified bodies are the ones which must ensure that these considerations are duly followed by notified bodies. They must ensure that notified bodies always perform a careful review of the manufacturer’s technical documentation relating to the status and operations concerning the audits and devices in question.
When considering the possibility of conducting remote audits, notified bodies must take into account the activities carried out at the site to be audited, the manufacturer’s quality management system and, where applicable, the level of compliance from previous audits. Following this review, a risk analysis must be conducted by the notified bodies. All the results of the assessment must be documented and duly substantiated.
Exceptional scope of the remote audits
The European Commission reminds that this measure shall remain extraordinary, and therefore used during a limited period of time until on-site audits are again possible.
The European Commission provides that it will closely and regularly monitor the situation related to the implementation of the Medical Devices Regulations, including in particular the provisions on conformity assessment. For this purpose, it invites EU Member States to systematically notify the use of temporary extraordinary measures and submit information about:
- measures taken by individual notified bodies to perform conformity assessment not in compliance with the on-site requirements for audits, also in case of surveillance assessment, including information to justify the use of such measures; and
- the period of time for which certificates issued by notified bodies following the abovementioned will be affected by non-compliant procedures concerning audits not performed on-site.
This Notice is a long-awaited decision that will have direct implications for manufacturers which are ready to transition to the MDR or IVDR but were unable to go through a conformity assessment due to the inability of their their notified bodies to conduct on site quality management system audit. However, decision to conduct remote audits will be taken on a case by case basis and it will be important for manufacturers to appropriately justify their request to the notified body. Our team would be pleased to assist with the preparation and justification of these requests.