I think there are definitely circumstances where the affixing of the CE mark can be after installation, for example where a device needs to be assembled and tested at the user site. While the device may have been assembled and tested at the manufacturing site, it may need to be disassembled for shipment, then reassembled and functionally tested at the user site before it can be demonstrated to meet the ERs of the Directive.
It should be understood that the post-installation functional check is the final activity necessary before the device can be 'put into service' (as defined in the MDD:
"'putting into service' means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose"). Only at this point can the CE mark be applied to the device to confirm that it is ready to be put into service. It would be useful for the Work Instruction for the installation to clearly explain why the CE label cannot be applied prior to this final installation check, however.
See also MDD Artlicle 2: "Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose."
In addition, the 2016 EU Blue Guide (Section 2.5) explains that:
"The need to demonstrate compliance of products at the moment of putting into service, and – if applicable – that they are correctly installed, maintained and used for the intended purpose, should be limited to products:• which have not been placed on the market prior to their putting into service or which can be used only after an assembly, an installation or other manipulation has been carried out."
I believe this therefore clears the way for the CE mark to be affixed only after an assembly and succesful functional check at the user site for specific types of medical device.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com------------------------------
Original Message:
Sent: 08-Dec-2017 18:56
From: Elizabeth Goldstein
Subject: Affixing CE Mark during installation
Hi Anonymous,
I would agree with the anonymous responder:
I assume the activities you describe are taking place in an EU country. When a CE marked device is placed on the market, the labelling is required to be compliant with the relevant EU directives. If you don't apply the CE mark until after it is placed on the market, then technically the product is non compliant at the time it is imported into the EU.
(This is per the MDD, which states that "Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.")
Also labelling procedures are typically part of a controlled quality system activity performed within the manufacturer's facility. If the "labelling" step you perform is not controlled by the mfr's QMS then the NB may have an issue with that too.
(I would add that labeling is part of the product and the labeling process is considered manufacturing, so should be conducted/applied in a controlled manner.
ISO 13485 - 7.5.1 states that "Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specifications. As appropriate, production controls shall include but are not limited to: e) implementation of deinfed operations for labeling and packaging.")
I am curious though - what is the reason for wanting to apply the CE mark at the point of use?
------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
California
United States
Original Message:
Sent: 08-Dec-2017 14:34
From: Anonymous Member
Subject: Affixing CE Mark during installation
This message was posted by a user wishing to remain anonymous
I assume the activities you describe are taking place in an EU country. When a CE marked device is placed on the market, the labelling is required to be compliant with the relevant EU directives. If you don't apply the CE mark until after it is placed on the market, then technically the product is non compliant at the time it is imported into the EU.
Also labelling procedures are typically part of a controlled quality system activity performed within the manufacturer's facility. If the "labelling" step you perform is not controlled by the mfr's QMS then the NB may have an issue with that too.
Original Message:
Sent: 07-Dec-2017 15:46
From: Anonymous Member
Subject: Affixing CE Mark during installation
This message was posted by a user wishing to remain anonymous
Does anyone see a problem affixing CE mark to a CE-certified medical device in EU after successful acceptance testing of the installed device in the customer's site (hospital/clinic)? I am fighting my NB on this. Thanks.