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Role of economic operators (EO) post the EU MDR Date of application in May 2020

#1
I am a little confused about the role of economic operators (EO) post the EU MDR Date of application in May 2020. Is it expected for the EO to take on and start performing all the additional (new) obligations and MDR responsibilities immediately after May 2020 even if they are only involved with legacy MDD-certified devices or are they only supposed to comply with the EUDAMED registration until the devices they are dealing with are MDR-certified?
For example, do all manufacturers have to have a PRRC by May 2020 or only until when they get devices certified to MDR?
 

Marcelo

Inactive Registered Visitor
#2
You only need to comply with the MDR if you are under the MDR. If you are under the directives, you need to comply with the directives. The only exemption is that, even if you are under the directives, the requirements of PMS and registration of devices and Eos of the MDR apply at the date of application.

It's more or less like this (adapted from question 17 of the CAMD Transition Sub Group - FAQ – MDR Transitional provisions):

If under the MDD after DOA -

+ comply with MDD

- (minus) MDD PMD requirement

+ MDR PMS requirements
Post market surveillance (PMS)
(see Art. 83-86, 92 MDR including Annex III but without the PMS having to be an integral part of the QMS)

Market surveillance
(see Art. 93 – 100 MDR, but device standards to be met = Directives)

Vigilance
(see Art- 87-92 MDR).

+ MDR device and EO registration requirements
Registration of economic operators and of devices
(see Art. 31 MDR and Art. 29 MDR)
 
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