Notified Body MDD Technical Audit of our Technical Construction File

[CYoungmann]

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?

[MIREGMGR]

I wouldn't venture a guess without more knowledge of the situation.

What does your NB say in response to those same questions?

[rob73]

Funny we are just the opposite, our technical file audits (up until last year) were always on site, now we send them the our NB.
As miregmgr suggested, ask them what is going on.
Rob