[co-author: Vicky Vlontzou]
As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices legislation has been significantly affected. The MDCG has, therefore, prepared a guidance which outlines the temporary extraordinary measures to be followed by notified bodies during the pandemic to permit the continued certification of medical devices and assist in the prevention of potential medical device shortages. The guidance is immediately applicable.
The guidance provides that notified bodies may introduce temporary alternative extraordinary measures in place of on-site conformity assessment audits that have been impacted by COVID-19 restrictions. The guidance intends to cover the following audits performed by notified bodies as part of medical devices conformity assessments:
- Surveillance audits under the medical devices Directives;
- Audits conducted for re-certification purposes under the medical devices Directives;
- Cases where a manufacturer submits a change notification to a notified body that would typically require on-site audit verification;
- Cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body for the conformity assessment of the same device(s).
The guidance provides that in general initial certification audits or audits to extend the scope of certification should not be performed using these temporary extraordinary measures. However, the guidance suggests that exceptions may apply to medical devices which are essential to ensure medical care during the COVID-19 pandemic.
Although the guidance only applies to medical device Directives, its principles may also apply to the medical devices Regulation (EU) 745/2017 and the in vitro diagnostic medical devices Regulation (EU) 746/2017 in the event that the availability of devices is affected by COVID-19 restrictions.
The guidance proposes the following principles and arrangements when implementing alternative extraordinary measures on on-sites audits:
- Postponement of on-site surveillance audits under the Directives in line with the documented procedures of the notified body for force majeure;
- Replacement of on-site audits by remote audits in accordance with information security and data protection legislation;
- Assessment of all relevant and required documents/records off-site by the notified body;
- Taking into account existing recent results from the Medical Devices Audit Program (MDSAP) audits or other appropriate audits, in lieu of Directive audits where available;
- Considering public international guidance on how to use information and communication technologies such as those issued by the International Accreditation Forum (IAF).
The guidance further provides eligibility criteria for implementing temporary alternative extraordinary measures such as possessing the appropriate technological tools. Those tools include web conferences with document sharing and web cams for audits of production lines.
The possibility to implement those measures to on-site audits should be documented and assessed by notified bodies on a case-by-case basis and performed using a risk-based approach.
Designating authorities may request to observe such remote audits.
If your company could fall within the scope of these temporary alternative extraordinary measures, we would recommend that you immediately contact your notified body to discuss the application of this guidance.