Notified Body Told to Pull Guidance on Remote Audits
The European Commission has ordered EU notified body TEAM-NB to withdraw a position paper it published on virtual audits, telling the firm it issued the paper without the proper authority.
“It appears that there are differences in the approach between National Competent Authorities concerning the implementation [of] the Commission Notice 2021/C 8/01 on remote audits under the Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR),” Team-NB said in a statement on its website.
“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. The application of remote audits under [the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR)] due to pandemic-related contact and travel restrictions may currently vary across member states depending on the governance provided by authorities,” the notified body said.