Importing prototype without CE (dos and don'ts )

Ajit Basrur

Staff member
Admin
#11
You can't import a finished medical device without CE Marking into the EU, unless it's a device for clinical investigation.


For a clinical investigation device, only in the define sites for the investigation.


For a clinical investigation device, in patients, obviously.


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.
Marcelo, could you provide me the weblink for this information? Thanks!
 
Elsmar Forum Sponsor

SKM.Sunil

Involved In Discussions
#12
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?

Yes, you can import a prototype to your own company only. You have to clear standard customs. This device is not meant to be placed in the market. I would rather suggest go with parts and assemble it in you premise in EU. You can fulfil all requirements in a legal way. :horse:
 
Thread starter Similar threads Forum Replies Date
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) 13
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
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
G Prototype Manufacturing Equipment - Validate or not to validate? Quality Manager and Management Related Issues 2
P Can Data gathered from Prototype Units be used in Submissions for CE Marking? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom