fbpx

Blog

no news = good news?

Regulatory Rabbit

Monday morning, another busy day in another busy week. Here I am at my desk again, first coffee of the day closeby while lining up my todos for the day and the week. Quickly checking the news on RAPS, LinkedIn, Nando. I’m not even checking properly, but merely screening through. Yup, I’m looking for something particular…

Q1 is drawing to a close and I’m itching to see our notified body’s designation confirmed. But they haven’t confirmed anything thus far, and that’s no good news. No news, in this case, seems to confirm rumours I’ve heard that spoke about… Q2.

And for now, I’m neglecting this as rumours, while a part of myself is slowly, carefully preparing my mental – and submission – state for the unspeakable that will lie before us if our NB designation should really coincide with or even take place after the MDR date of application.

Regulatory Rabbit

If I spoke about todos before, that is a tiny list compared to what there is in stock for our NB, hahaha. Ghosh, I have sooooo many questions and proposals for our NB once they are finally MDR-designated. So, couldn’t I just take these and ask another of the few notified bodies that are already designated? Well, I don’t really think so as, apart from lack of capacity, there may (and will be!) different approaches and interpretations. I need the opinion of our notified body. And because notified bodies don’t officially consult their customers, I know the process of drawing information from them will anyways be lengthy and complicated so the quicker we start, the better.

Regulatory Rabbit

But, still, no news… Which can lead to ridiculous situations sometimes. Like a few weeks ago, when I went through all these codes of the MDR, with MDNs here and MDTs there and stuffing CNDs in lieu of EMDN where they would fit, or rather as I saw fit, in an effort to get a glimpse of what our MDR future regarding certificates and audits might look like. What a chaos. lol. And a possibly futile exercise carried out according to orders from higher management. As, without any means of getting feedback from our NB, I’m not sure it helped the higher-ups to gain more clarity and it went into my files and folders to be discussed with the NB. With regards to the higher-ups, I’m inclined to believe it didn’t help them as I didn’t receive any further requests from them. Well, at least in that case, no news is definitely good news, hahaha.