Notified Body MDD Technical Audit of our Technical Construction File
We are a small (less than 18 people) firm manufacturing sterile disposable needle electrodes for electromyography and electroencephalography—very simple, not technically complex devices. Our needle and lead sets are MDD Class IIa devices.
Our notified body, BSI, is planning a on-site, technical audit of our Technical Construction File. This audit will be the third within a year; the previous two were a biological audit directed at our cleanroom and sterilization procedures, and a quality system audit reviewing our processes.
In 15 years of EU regulatory work, the only technical file audits I have ever had were always done by submission, never on-site. Has there been a change in NB guidance that has prompted this? Does anyone understand why this might be happening?