Class I Medical Device will be Class IIa after new MDD

R

Riskophil

#1
#1
Hi everyone,

we already know that with the upcoming version of the MDD some of our medical devices will be class IIa/b. What will the notified bodies do with these products? Will they have to certify them? How much time will we have for the certification? :confused:

Thanks and regards,

Phil
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
M

Marcelo

Inactive Registered Visitor
#2
#2
Re: Class I device will be IIa after new MDD

You will probably need to update your documentation, and probably will have the transition period to do that. Depending on the device and the route, you will also probably need a reassessment of the conformity route.
 
R

RobertvanBoxtel

Involved In Discussions
#3
#3
Re: Class I device will be IIa after new MDD

Hi Phil,

Still time left before the formal publication. And then Notified Bodies will have to be renotified, possibly through another joint audit of competent authorities. And then you NB will have to review and certify.
Best course for action:
1. Download the proposal text of the MDR, to be discussed tomorrow.
2. Look into Annex II on the technical file requirements
3. Update your files to these requriements.
4. Then, look into the QMS requirmeents as identified in Article 8 and related Annex VIII.
5. Upgrade your QMS.
6. Talk already with your current NB on including those products in their schedule 2018-2019.
 
Salisburysteve

Salisburysteve

Starting to get Involved
#4
#4
Hi,

If you only make Class I devices now then your QMS does not need a notified body. With the change to Class IIa/b then a notified body is required and if it wasn't already, your QMS should be ISO 13485 based.

You will also have to consider your routes to CE marking, see Article 11 in the present MDD.. I haven't got that far in the new one..

Regards,

Steve
 
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