Hello everyone,
note that ROHS does not call for the intervention of a notified body to verfy the conformity assessment procedure - i.e. a NB does not have a role to play with your ROHS TF. The ROHS TF and DoC need to be available for Competent Authorities but not to NBs
Medical devices need to comply with all applicable regulations in the EU before they are placed on the market (in EU), and the CE mark cannot be affixed unless
all applicable conformity assessment procedures have been completed. For an active device these could inlcude: MDD, ROHS and RED (radio equipment directive). Whether a notified body intervention is required is normally specified in the appplicable conformity assessment annex.
Thus, I would say that you can submit your MDD TF before the ROHS TF and DoC are completed. However, you want to be sure that compliance to ROHS will not lead to design changes that will affect the MDD TF. Both have to be completed and the DoCs signed before products are placed on the EU market.
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Andrea Sparti
Regulatory Affairs Manager
Bienne
Switzerland
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Original Message:
Sent: 01-May-2018 18:26
From: Anonymous Member
Subject: Does RoHS Tech File have to be complete to start CE Tech File review by NB
This message was posted by a user wishing to remain anonymous
Hello everyone,
I don't have an answer for Reka's question but want to clarify an additional item related to the original question posted to this thread...
For a Class-1 device: Does the RoHS TF have to be complete before the CE TF can be considered as completed with a Declaration of Conformance statement? In other words, can the DoC for the CE TF be written with a promissory commitment that RoHS TF will be completed prior to shipment?
Thanks
Original Message:
Sent: 13-Dec-2017 10:00
From: KATHERIN HARRIS
Subject: Does RoHS Tech File have to be complete to start CE Tech File review by NB
We recently did the same with BSI. They agreed to review the TF until we had our RoHs information ready. It took awhile but we did eventually get it in. I suppose it depends on your reviewer but they seem pretty ameniable to that if you give appropriate justification.
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KATHERIN HARRIS
Seno Medical Instruments
SAN ANTONIO TX
United States
Original Message:
Sent: 13-Dec-2017 08:13
From: Eric Bannon
Subject: Does RoHS Tech File have to be complete to start CE Tech File review by NB
Hello Ryan,
I have used BSI and had the RoHS information in the technical file when it got submitted for review. If you do not have that currently, I would draft a letter detailing your current status for the NB and provide assurance on completion. They may accept the file for initial review.
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Eric Bannon
Newburyport MA
United States
Original Message:
Sent: 12-Dec-2017 10:01
From: Anonymous Member
Subject: Does RoHS Tech File have to be complete to start CE Tech File review by NB
This message was posted by a user wishing to remain anonymous
Hello everyone,
we are trying to look at ways of getting our device CE Tech File to our NB as soon as possible so that the review of the CE TF is started while the RoHS TF is still going through its development. Does the RoHS TF have to be complete for the NB start the CE TF review?
What rationale did you use to defend this approach with your NB?
It is understood that we will not export to member countries until after RoHS (and REACH) compliance are also complete.
Thanks