The European Commission's Medical Device Coordination Group is allowing notified bodies to perform remote audits during the coronavirus outbreak, according to a guidance posted Wednesday.
The MDCG detailed how notified bodies can run audits while quarantine orders and travel restrictions are stopping them from conducting site visits.
- The pandemic-oriented guidance the day after the Council of the European Union responded to the Commission's proposed delay of the Medical Device Regulation. The Council’s planned amendments to the proposal clear up the confusion over whether the delay applies to all aspects of MDR.
Travel restrictions across the EU are stopping notified bodies from performing the on-site assessments central to their work. Recognizing that threat to the supply of medical devices, MDCG, an advisory group consisting of member state officials and industry players, laid out temporary measures notified bodies can take to work around the restrictions.
In some circumstances, notified bodies may perform remote audits. That option is open to notified bodies that have to carry out surveillance and recertification audits under the device directives, as well as when a manufacturer has filed a change notification or switched to a different notified body.
MDCG developed the guidance primarily to help notified bodies designated under the outgoing device directives. However, the advisory group said the flexibility provided in the guidance may apply to MDR and IVDR “in the event that the availability of devices is affected by COVID-19 restrictions.”
If an audit falls within the scope of the guidance, a notified body can leverage technology to perform a remote assessment. The guidance permits the off-site assessment of documents and records, and use of results from audits run under the Medical Device Single Audit Program, an initiative involving FDA and other regulators outside of the EU.
MDCG expects notified bodies to assess how to make use of the flexibilities provided by the guidance on a case-by-case basis. In doing so, notified bodies should consider the risks of each case, for example by factoring in their experience of the manufacturer and its compliance record.
The group is still developing guidance on the operational implementation of the principles.
Details of the flexibilities available to notified bodies emerged a day after the Council advanced the planned delay of the MDR date of application. Having received the proposal from the European Commission on April 3, the Council filed its response April 7.
The Council’s proposed changes clear up uncertainty created by the Commission’s submission. In its proposal, the Commission left the May 26, 2020, deadline in place in a part of the legislation about Class I devices. The Council is proposing to change the date to May 26, 2021, in line with the delay applied elsewhere in the document, thereby eliminating concerns that Class I devices would become subject to certain transition requirements starting next month.
With the Council supporting the delay, the proposal will now move to the European Parliament. The Parliament is expected to hold a vote on the amended legislation on April 16.