Sampling of Class IIb Implantables under EU MDR - Assessments to the EU MDR

Chrisx

Involved In Discussions
#1
I'm trying to budget for the upcoming assessments to the EU MDR. I understand that no devices will be grandfathered under the new MDR. However, does this mean all technical files have to be re-assessed under the new MDR? Reading article 52 clause 4, class IIb devices that are a suture, staple, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connnectors, would have a sample assessment of the technical documentation from each generic device group. I am assuming that generic device group equates to GMDN code as it was under the MDD. If it is some other type of class IIb implant, then all technical documentation has to be assessed. Do I have this correct?
 
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chris1price

Trusted Information Resource
#3
Hi
Firstly, you are correct, there is no grandfathering under the new regulation.

Article 52, Para 4 says.....

"Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.

However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4Annex IX shall apply for every device."
(My emphasis)

So I believe you are correct, other than the devices specified, all Class 2b implantables will have their technical documentation assessed.

I would strongly recommend talking to your NB as soon as possible about this and getting confirmation of their reading of the MDR and their plans. There could be a long queue wating for assessment and a limited number of assessors. 3 years transition is not a lot of time!

Chris
 

Chrisx

Involved In Discussions
#4
Thanks for the advice. I agree working with the notified body to establish a sampling plan at an early stage will be important. Nobody knows when the notified bodies will be notified to the MDR. There are rumors of 18-months. For sure, we don't really have 3-years. The sooner we start the better.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Nobody knows when the notified bodies will be notified to the MDR. There are rumors of 18-months.
It's not a rumour. It's the result of calculating the minimal timeline based on known requirements and limitations. I'm not sure but I think BSI explained it in one of their white papers, or something...

There won't be any NBs notified for MDR in the next 1.5 years.
 
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