The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (MDCG 2020-4).
This document provides more details on the operational and practical implementation of the principles outlined in the guidance document MDCG 2020-4 and must be read in conjunction with it.
As mentioned in the MDCG guidance in April this year, although it applies to the medical device Directives only, the principles in this guidance may apply for Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) in the event that the availability of devices is affected by COVID-19 restrictions.
Below some of the Questions & Answers from the new MDCG document :
Is it possible to conduct remote audits in order to extend the scope of certification?
In order to ensure medical care and to prevent the shortages of products on the market, audits to extend the scope of certification under the Directives may be performed using the principles and guidance outlined in MDCG 2020-4. This also requires the notified body to perform a case-by-case assessment, justified and documented as outlined in section 5 of the guidance.
What devices are considered “clinically necessary during the period of COVID-19 restrictions”?
A list of essential medical equipment related to the COVID-19 pandemic has been developed by the Commission jointly with the Member States and agreed by the MDCG. The list is published at Commission’s website and may be subject to future updates, if needed. Devices listed can be considered “clinically necessary during the period of Covid-19 restrictions”.
Can unannounced audits be conducted remotely?
The postponement of the MDR date of application by one year was adopted by the EU co-legislators in order to alleviate pressure to all actors involved, including notified bodies, deferring the date of repeal of the Directives. In addition, MDCG 2020-4 was endorsed by the MDCG in order to allow notified bodies to perform alternative extraordinary measures and arrangements to on-site audits, including remote audits, in the context of COVID-19 pandemic in order to support the continued supply of medical devices on the market. Although the conduct of unannounced audits is outside the scope of MDCG 2020-4, from a risk-based approach, it is recognised that these audits may be postponed and that the recommendations in Article 2(c) and Annex III of Commission Recommendation 2013/473 may not be followed during the period of the pandemic.
Is any special preparation on the notified body or manufacturer’s side necessary in advance of conducting a remote audit?
Once the remote audit has been announced, the notified body should agree with the company to be audited the electronic system that will be used to conduct the remote audit and the staff members needed to be during the audit. Moreover, the notified body may request the company to provide access to, or, send in advance all of the documents related to the audit, in order to be assessed by the notified body in advance. Both the notified body and the manufacturer should verify the ICT agreed upon to ensure that the remote audit can be carried out properly, see question 3.1 of this document. In addition they may have a videocamera system to allow the notified body to watch their facilities if necessary. The use of videocameras would require a risk assessment on a case-by-case basis. The manufacturer should ensure the availability of relevant documents and records during the remote audit and that their system gives the possibility to share the documents with the notified body.
Does the notified body have to retain all documentation submitted by the manufacturer for later review, or can it be properly disposed of and notified to the manufacturer?
With regard to remote audits conducted in line with MDCG 2020-4, it is the expectation that the notified body ensures that documentation records are sufficient to provide a discernible audit trail for quality management system audits and that such records should be available to relevant authorities. As with any audit, evidence gathered during the audit should be appropriately recorded and where considered necessary, copies of relevant documentation should be retained. Documentation should be treated in confidence as per legislative requirements.