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Informational From RAPS – UK NB Will Not Apply for EU MDR/IVDR

yodon

Staff member
Super Moderator
#2
Any idea if there's been any contingency planning? There's currently only 2 NBs designated. I saw in another article you posted that 10 more are in the 'final stages' of designation. That's clearly WAY SHORT of what's needed.
 
#4
I'm conflicted by this.

the viability of this is a serious concern - if more notified bodies don't step up then the system will fail, however it indicates to me that things have been a bit too lax in the past and the regulation/supervision of products needs to step up

Where should this be positioned? Should we increase oversight and regulation with the goal to improve product safety and efficacy at the cost of avaliability of products on the market?

I don't think the MDR is too much, but perhaps it is too fast?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
I don't think the MDR is too much, but perhaps it is too fast?
1. Yes.
2. When the MDR was initially created and approved too many things were left "to be done later". Estimates were optimistic rather than realistic.
3. Almost everyone (manufacturers, EU authorities, NBs etc.) were sleeping in the sun for at least a year after the MDR came into force (May 2017) while they should have been busy bees drom day 1.
 

QM_123

Starting to get Involved
#7
As I know currently there are more than 50 NBs designated for MDD. After 11 months MDR will enter into force but now there are only 2 NBs designated for MDR. How many NB will be desginated until May 2020, do you have foresight or prediction on this matter?
 

Rincewind

Involved In Discussions
#8
As I know currently there are more than 50 NBs designated for MDD. After 11 months MDR will enter into force but now there are only 2 NBs designated for MDR. How many NB will be desginated until May 2020, do you have foresight or prediction on this matter?
I have read they expect somewhere between 12 and 20 notified bodies for MDR by the end of the year.
MedTech Europe letter is suggesting 12 NBs.

https://www.medtecheurope.org/wp-co...n_MDR-implementation-status_15-April-2019.pdf
 

Attachments

#9
3. Almost everyone (manufacturers, EU authorities, NBs etc.) were sleeping in the sun for at least a year after the MDR came into force (Mat 2017) while they should have been busy bees drom day 1.
I don't disagree that everyone was slow to start, however I have said from when I read the initial proposal that I wasn't sure where all of the expertise was going to come from - NBs need more experts, manufacturers need experts, EC-reps need experts etc etc...We already have a situation where there are not enough technical experts to support the notified bodies under the MDD, this isn't going to disappear with the additional burden from MDR. It is not quick and easy to train people up to the level that is required
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#10
I just created another news, which will be published here in a while, it's a report from the EU Council, and, as always the report from the commissioner is that everything is working as planned.

I understand the concerns, but my view is that everything that is happening was already taken into account (you can read, for example, the 200+ pages of the REPORT ON THE IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES from 2012 and see that most of the things being discussed today were already noted) and thus, although some things need to be checked and revised, in general things are going ok.

In fact, my experience shows that the parts that are really not prepared are the manufacturers because they still do not understand the concept and scope of the new MdR (despite Medtech Europe saying that the manufacturer are "prepared").
 
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