2022 is just a recommendation on the safe side.
Seems like good advice. I gave up following the EU after the EC caved on the deadline, so I was wondering if some sort of timeline had been announced. Based on the EC's initial failed effort, I would prioritize finding an NB above all else. Doesn't matter how complete your tech files are if you have no NB to review them.
Most of the CERs I've seen so far have been somewhere in the lowest grey areas, but still have been accepted. It did not improve much with revision 4 of the
MEDDEV 2.7/1.
Yeah, that's been my experience, and I've never heard anything different from anyone who ever picked up a CER that hadn't been prepared by someone with a background in both RA and clinical or scientific writing. There was a measurable effort within industry to get more appropriate people to write them when they went to Rev 4, but there were also many, many companies that did not make this effort.[/QUOTE]
You know, the main reason to create the MDR was that the NBs and competent authorities interpreted the MDD as gold standard that noone needs to fulfil completely, they have been very lenient.
I don't know the main reason for the MDR.
- At first I thought it was because the NBs were not holding companies to the standard the EC had expected when it released the MDD, which I think left a lot of room for interpretation/wiggling/waffling. I thought of it as the EC saying to the NBs, "Read our lips, this is how you do it."
- Later I thought it might also have been an effort to give the NBs a solid foundation on which to stand. They are profit-making enterprises. They are unlikely to hold a customer's feet to the fire unless a requirement is very, very clear, because that will just cost them business, when there will be other NBs interpreting the same requirement more to a manufacturer's liking. So, still the EC saying "Read our lips," but to the companies as much or more as to the NBs.
- Finally, watching how it played out on the first try, I wondered if it wasn't mostly an effort by some of the NBs to eliminate competition, meaning they were really the power behind it, not the EC. That would be a very viable hypothesis in the US, only it would be the bigger device companies trying to eliminate competition by getting FDA to raise the bar. I don't know much about EU politics, though.
In any case, whatever the motive, I and others hoped it would wash out a good number of the companies and devices that should never have been on the market in the first place. Could be they will apply the MDR more strictly than the MDD, but the EC caving on the deadline did not strike me as a promising sign.