Dive Brief:

• Team-NB has withdrawn its position paper on the implementation of remote audits in the European Union in light of country-to-country variation in acceptance of the approach.

• The European Commission appeared to open the door to remote audits in January. However, the publication also implicitly revealed resistance in some member states to the approach and reiterated that national authorities are responsible for notified bodies.

• The European trade group for notified bodies had shared a position paper intended to inform a harmonized approach last month but was unable to finalize the text in the face of continued divergence between member states. A Commission medical device group met last week but is yet to disclose a solution.

Dive Insight:

Early last month, Team-NB said the Commission and national authorities were working to achieve a harmonized approach to the implementation of the notice that opened the door to remote audits in January. Such an approach would enable notified bodies to perform remote audits under the incoming device and in-vitro diagnostic regulations when COVID-19 prevented in-person visits. 

However, while Team-NB has sounded the alarm over the effects of the pandemic on preparations for the incoming regulations, there remains resistance to the remote audits.

“It appears that there are differences in the approach between National Competent Authorities. Therefore, at this time, Team-NB is unfortunately unable to finalize and publish its aligned position on the uniform implementation of such remote audits by Notified Bodies," Team-NB wrote. "The application of remote audits under MDR and IVDR due to pandemic-related contact and travel restrictions may currently vary across Member States depending on the governance provided by authorities.” 

Signs of differences in approaches to remote audits between EU countries were apparent in the text released by the Commission in January. After discussing the topic at two meetings late last year, the Medical Device Coordination Group and “the vast majority of the Member States” recognized the potential need for remote audits in exceptional circumstances, the Commission said. The statement implies a minority of countries still opposed remote audits at that time.

The opposition has now manifested in the withdrawal of the Team-NB position paper. MDCG met with stakeholders to discuss topics including notified bodies under the incoming regulations but, as it stands, there are no public signs of progress.

The device coordination group is scheduled to meet with stakeholders in late May.