Importing prototype without CE (dos and don'ts )

#1
We want to import a non-CE prototype of our successor (MDD Class I) from our mother company (manufacturer in Japan) into the UK to some tests with it .

Can someone tell me what are the dos and don'ts for this?

1. Are there special requirements for the import ?
2. Can we use the device in our office ?
3. With or without patients ?
4. At what level we need MHRA approval and/or IRB?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
1. Are there special requirements for the import ?
You can't import a finished medical device without CE Marking into the EU, unless it's a device for clinical investigation.

2. Can we use the device in our office ?
For a clinical investigation device, only in the define sites for the investigation.

3. With or without patients ?
For a clinical investigation device, in patients, obviously.

4. At what level we need MHRA approval and/or IRB?
Before importing. You need to draw up a CE marking for the device, contact MHRA and follow it's procedure, have it's "approval"then you can import the device.
 
#3
As you are, effectively, not 'placing the device on the market' you may be able to import the product. This demands that you and your 'parent company' are part of the same economic entity.

It would also be a good idea to label the device very prominently (before shipping) along the lines of 'Caution: this medical device is not CE marked and must not be marketed or put into service'. See Article 4, paragraph 3 of the MDD.
 

Marcelo

Inactive Registered Visitor
#4
As you are, effectively, not 'placing the device on the market' you may be able to import the product. This demands that you and your 'parent company' are part of the same economic entity.

It would also be a good idea to label the device very prominently (before shipping) along the lines of 'Caution: this medical device is not CE marked and must not be marketed or put into service'. See Article 4, paragraph 3 of the MDD.
I'm not sure if you mentioned Article 4, paragraph 3 only for the label, but in general it's not applicable to internal prototypes, only for medical devices (finished) that are shown. We can argue that these can include prototypes (who would know the difference?) but it's clearly not the intention of the paragraph.

Regarding the OP, unfortunately, there's no clear mention of prototypes in the directives, and manufacturers often thinks that prototypes do not need any oversight, which is not true. We may argue that initial prototypes (internal, not to be used in humans) will not comply with the regulations, but a prototype to be used in humans (usually near-finished or finished), which seems to be the case of the OP, you need to comply with the regulations, and as I mentioned, you need for it to be an investigational device.

As you need to comply with the regulation, this goes back to my previous comment, the device which does not have CE Marking (in the way to complying with the regulation, it may not have the mark itself, as Annex VII mentions) cannot be brought into Europe.

So you may not have to apply the CE Mark, but you have to comply with the CE Marking Directive. Maybe this makes things more clear.
 

Mark Meer

Trusted Information Resource
#5
You can't import a finished medical device without CE Marking into the EU, unless it's a device for clinical investigation.
...
Regarding the OP, unfortunately, there's no clear mention of prototypes in the directives, and manufacturers often thinks that prototypes do not need any oversight, which is not true. We may argue that initial prototypes (internal, not to be used in humans) will not comply with the regulations, but a prototype to be used in humans (usually near-finished or finished), which seems to be the case of the OP, you need to comply with the regulations, and as I mentioned, you need for it to be an investigational device.
Hi Marcelo,
What about Article 21 (3) of the MDR?:

At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.
Does this not imply the import of a non-CE marked devices for demonstration purposes? And if for "demonstration", this seems to imply that it is acceptable to use on humans for this purpose, no?

Not certain what the parameters are here, aside from obviously no sales or distribution. Do you know if there is any guidance that elaborates on this particular clause?
 

Marcelo

Inactive Registered Visitor
#6
Hi Marcelo,
What about Article 21 (3) of the MDR?:



Does this not imply the import of a non-CE marked devices for demonstration purposes? And if for "demonstration", this seems to imply that it is acceptable to use on humans for this purpose, no?

Not certain what the parameters are here, aside from obviously no sales or distribution. Do you know if there is any guidance that elaborates on this particular clause?
No, "demonstration" here is for showing, not using. The general idea (which is more easy to understand than my comments above) is that you cannot use a device in humans if it does not comply with the regulations. Usually regulations enables this by requiring that the device is not put into market or made available (but please note that these latter terms are not standardized worldwide).
 

Mark Meer

Trusted Information Resource
#7
No, "demonstration" here is for showing, not using. The general idea (which is more easy to understand than my comments above) is that you cannot use a device in humans if it does not comply with the regulations. Usually regulations enables this by requiring that the device is not put into market or made available (but please note that these latter terms are not standardized worldwide).
If this is the case, it's curious that they would have separated terms "presentation" (which I'd interpret as "showing"), versus "demonstration" (which I'd interpret as demonstrating the device in action). In many (most?) cases it'd be very difficult to properly demonstrate a device without involving a subject at some level.

Is this a matter of interpretation of the text of the regulation, or is there actually some official guidance available? (not that I don't trust your expertise ;))
 

Marcelo

Inactive Registered Visitor
#8
The usual name for this, including in other languages as far as I know, is demonstration at trade show. I've never seen the term being used as "showing at a trade show". But again, AFAIK, this does not imply use in humans.
 

Ronen E

Problem Solver
Moderator
#10
In many (most?) cases it'd be very difficult to properly demonstrate a device without involving a subject at some level.
Maybe many, not most IMO. If you'd consider the entire range of medical devices you'd realize that in most cases some level of demonstration (which I take to include some level of action or simulated use) is quite possible without a human subject.

Besides, please note that the Article's text uses both the terms "demonstration" and "presentation" in relation to the sign that must be provided, and that the actual requirement relates to "the showing of".
 
Thread starter Similar threads Forum Replies Date
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 0
D Importing a general wellness low risk product Other US Medical Device Regulations 3
S Importing Medical devices class I in EU Other Medical Device and Orthopedic Related Topics 5
O Importing a Medical Device into the US from abroad 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
M Importing a Registered Class II Device, the Applying Our Label - Need New 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F Mexico Medical Device Importing and Servicing Other Medical Device Regulations World-Wide 2
ScottK Importing medical device for use in fit testing of packaging Other US Medical Device Regulations 3
M Importing medical devices to EU, Germany EU Medical Device Regulations 6
M Importing a Demo Medical Device into the US US Food and Drug Administration (FDA) 3
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
J Importing a Finished Medical Device from China (tooth whitener w/ peroxide) China Medical Device Regulations 2
O Importing Data via Script - Assign Column as Text (Minitab) Using Minitab Software 3
W What Information is provided when Importing Products into USA US Food and Drug Administration (FDA) 1
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
S Importing a DC motor to UK that is less than 50VDC CE Marking (Conformité Européene) / CB Scheme 11
P Requirements for Importing Hydrocolloid Bandages into the US from China Other US Medical Device Regulations 2
Q FDA Registration and Importing Medical Device Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
N Importing Diagnostic kit from US, UK Other Medical Device Regulations World-Wide 5
B Class I Medical Device Importing for OEM Requirements EU Medical Device Regulations 3
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
M Importing Material before the 510(k) is Approved 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Importing CE marked Syringes Into the US Other US Medical Device Regulations 2
I Importing Medical Devices into the USA from Germany (Drop Shipments) US Food and Drug Administration (FDA) 2
D Importing Class II Male Latex Condoms From China to US Other US Medical Device Regulations 2
L Importing exempt Class I device from non-registered manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Importing Breathalyzers into the USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Stijloor Importing Address Books (Thunderbird and Outlook Express) into Windows Live Mail After Work and Weekend Discussion Topics 3
G Importing Medical Device Software to India - Diagnostic Imaging Application Other Medical Device Regulations World-Wide 8
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
S Exporting then re-Importing 510(k) device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Regulations for importing an IVD diagnostic test in India Other Medical Device Regulations World-Wide 16
bio_subbu CDSCO?s checklist on importing non-critical IVD products in India Other Medical Device Regulations World-Wide 1
amjadrana Importing Medical Devices with Computers as part of the device in Turkey Other ISO and International Standards and European Regulations 1
D Medical Device Regulations - Importing to Singapore - Orthodontic brackets Other Medical Device Regulations World-Wide 5
D How to obtain NOC from DCGI (Drug Controller General of India) for importing drugs Manufacturing and Related Processes 6
G Portocal II - Importing procedures Calibration and Metrology Software and Hardware 2
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
V Prototype for chemical supplier IATF 16949 - Automotive Quality Systems Standard 0
A Prototype control plan FMEA and Control Plans 2
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
I R&D prototype documents need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Help develop sampling plan for prototype samples (medical devices) Statistical Analysis Tools, Techniques and SPC 7
H Reliable Prototype PCB service manufacturer Manufacturing and Related Processes 3
B IATF 16949 clause 8.3.4.3 Prototype programme IATF 16949 - Automotive Quality Systems Standard 0
C AS9100 7.3 - Prototype Design Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Customer wants a PPAP/PSW on some Prototype Parts APQP and PPAP 6
4 ISO9001:2008 Prototype Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R FAI Prototype Drawing Revision Levels AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4

Similar threads

Top Bottom