Importing medical devices to EU, Germany

M

michaelpui

#1
We are buying office.
Right now, we want to import suction unit (Class IIb) from other country to EU (mainly in Germany).
the manufacturer provided the cert of CE0123 and 13485 to us already.

Case I: import under our own brand
we know we should be the "manufacturer" under medical device directive if the device sold by us under our own name, but not produced by us.

in this way, could we just import to Germany?
what is the regulatory requirement for the relabeling /repacking of OEM product with our own brand name & selling distributing the same in various EU countries?

Case II: import under the manufacturer's brand
We are not the manufacturer now, so could we just import to EU? what is the regulatory requirement here?

Any help with this is greatly appreciated! :thanx:
 
Elsmar Forum Sponsor

somashekar

Staff member
Admin
#2
So you are based in the EU.
Case I: import under our own brand
Get an OBL CE from a NB. Preferable is the 0123 NB itself. Register the device in Germany and Import and market. The labeling and packing in your name can also be done by the OEM.
Case II: import under the manufacturer's brand
Has manufacturer registered the device in Germany. Import and market.
Look at other regulations concerning to imports.
See into DIMDI
 
Last edited:
M

michaelpui

#3
Thank you for your help !! :agree:

YES, we are based in EU!

Case I: import under our own brand
Get an OBL CE from a NB. Preferable is the 0123 NB itself.
-> so we apply for OBL by TUV SUD (0123) and they issue OBL CE cert (another 0123 CE cert) to us with our company name, right?

Register the device in Germany and Import and market.
-> registered by the national competent authorities?

Case II: import under the manufacturer's brand
Has manufacturer registered the device in Germany. Import and market.
-> the manufacturer provided us CE0123 which has EC representative in Germany already. is it ok?

Look at other regulations concerning to imports.
-> we think the following standards related
CE0123 (Directive 93/42/EEC on MDD, Annex V)
EN 13485
EN 980
EN 1041
EN ISO10993-1
YY 0636.1
EN ISO14971
EN 60601-1-2

:thanx:
 

pkost

Trusted Information Resource
#4
As manufacturer in Germany you will have to notify the German competent authority that you are a manufacturer of medical devices. From recollection you have to appoint and inform the CA of a safety officer (see ? 30 MPG) - I'm not sure on the qualifications/competence required for this role
 
M

michaelpui

#5
Thanks! :thanx::thanx:

if we stick at Case II, then my company should not the manufacturer accordingly to MDD.
in this way, should we just import the medical device with CE0123 to Germany simply?
 
W

wrodnigg

#6
In case II you only treade with medical devices which are CE-marked by the manufacturer.

Just make sure, that there is a valid CE certificate and a current declaration of conformity. You can order the products from the manufacturer and sell the im Germany.

But: you must not alter the labelling or instructions for use of the medical device.
 
M

michaelpui

#7
Thanks
So for case ll
valid CE cert mean CE0123, right?

And
We have to keep the manufacturer's brand name to Germany
 
Thread starter Similar threads Forum Replies Date
S Importing Medical devices class I in EU Other Medical Device and Orthopedic Related Topics 5
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
I Importing Medical Devices into the USA from Germany (Drop Shipments) US Food and Drug Administration (FDA) 2
amjadrana Importing Medical Devices with Computers as part of the device in Turkey Other ISO and International Standards and European Regulations 1
O Importing a Medical Device into the US from abroad 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
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 a Demo Medical Device into the US US Food and Drug Administration (FDA) 3
J Importing a Finished Medical Device from China (tooth whitener w/ peroxide) China Medical Device Regulations 2
Q FDA Registration and Importing Medical Device Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Class I Medical Device Importing for OEM Requirements EU Medical Device Regulations 3
G Importing Medical Device Software to India - Diagnostic Imaging Application Other Medical Device Regulations World-Wide 8
D Medical Device Regulations - Importing to Singapore - Orthodontic brackets Other Medical Device Regulations World-Wide 5
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
D Importing a general wellness low risk product Other US Medical Device Regulations 3
I Importing prototype without CE (dos and don'ts ) EU Medical Device Regulations 11
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
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
N Importing Diagnostic kit from US, UK Other Medical Device Regulations World-Wide 5
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
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
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
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
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JoCam Accessories for medical devices EU Medical Device Regulations 5
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
M Prescription Form - Medical Devices US Food and Drug Administration (FDA) 0
XRAY_3121 Drop Shipping Legend Medical Devices Other Medical Device Related Standards 0
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Jessesun The application of ozone sterilization in medical treatment US Food and Drug Administration (FDA) 0
A Production line for medical devices Other Medical Device Related Standards 1
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom