CE Marking requirements - A Medical device with different config sold under same name

#1
Hello,

I am new to QA/RA. Our device is classified as Class IIa(MDD) and Class 1 510(k) exempt (FDA).We are planning to produce next generation of our product early next year. Existing configuration is expected to be live until end of next year.
Already we are in the Design phase for configuration 2.

I would like to know the following:

MDD(EU)
Is it required to list the two configuration in CE Certificate in order to sell both the device configuration (without changing the trade name)? If yes, is that possible via a normal notification of change to Notified Body or do we have to follow a new submission process?

U.S FDA
Can we maintain separate DHF and DMR per configuration type?
Our current DHF is incomplete and we plan not to fix it as that particular configuration will soon be phased out.

Looking forward to your valuable suggestions.

Regards,
S.Rajesh
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Z Direct Part Marking (DPM) requirements for Class II Medical Devices Manufacturing and Related Processes 0
N CE Marking Requirements for Class I Medical Devices EU Medical Device Regulations 2
R Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
J Marking (Labeling) Requirements on Medical Equipment per IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A CE Marking and Packaging Requirements for Class I Sterilized Medical Devices EU Medical Device Regulations 8
A CE Marking - Annex II Requirements for Class IIa Medical Device EU Medical Device Regulations 5
C Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements EU Medical Device Regulations 7
I CE Marking Medical Devices - Country Requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
J CE Marking Requirements and IEC 60617 - Electrical Schematics Symbols CE Marking (Conformité Européene) / CB Scheme 1
L Canada Electrical Equipment Marking Language Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Natural Rubber / Latex Product CE Marking - Requirements EU Medical Device Regulations 3
I UDI requirements vs Japanese Barcode Marking guideline Japan Medical Device Regulations 1
E ASTM D3951 Part Marking Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F Marking Requirements on Drawings (Prints) Document Control Systems, Procedures, Forms and Templates 1
F Softening Standard Test Requirements for CE Marking Other Medical Device Related Standards 4
M Content Requirements for a Declaration of Conformity (CE Marking) CE Marking (Conformité Européene) / CB Scheme 1
A Toy Company Doesn't Conform With CE Marking Requirements CE Marking (Conformité Européene) / CB Scheme 9
R Power Input Marking requirements in IEC 60601 and IEC 60950 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C FAA/PMA Part Marking Requirements Federal Aviation Administration (FAA) Standards and Requirements 2
D CSA Marking Requirements - IEC 60601-1 and CSA 622.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
I MDD: CE Marking Labeling Requirements - Two questions... CE Marking (Conformité Européene) / CB Scheme 7
O Understanding Requirements for CE Marking and Test Requirements CE Marking (Conformité Européene) / CB Scheme 12
D RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T Requirements for marking Laboratory Equipment Electrical Products Manufacturing and Related Processes 3
S CE Marking Requirements for a Product built from Embedded Kit Parts CE Marking (Conformité Européene) / CB Scheme 11
S Advice Please regarding CE Marking requirements for Printing Press CE Marking (Conformité Européene) / CB Scheme 4
ScottK Requirements for CE Marking a component to go into an assembly (PED) CE Marking (Conformité Européene) / CB Scheme 2
N CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc. EU Medical Device Regulations 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
G CE marking of MD and IVD set EU Medical Device Regulations 3
M CE marking for NON-EU EU Medical Device Regulations 0
NDesouza Getting Rid of Part Marking Errors Benchmarking 39
S CE marking for a product upgrade CE Marking (Conformité Européene) / CB Scheme 0
P CE Marking UK Membership CE Marking (Conformité Européene) / CB Scheme 1
J Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals CE Marking (Conformité Européene) / CB Scheme 4
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
A EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Clinical investigations of medical devices - not for CE marking EU Medical Device Regulations 0
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
Ed Panek Is Shelf Life Change a significant change? CE Marking CE Marking (Conformité Européene) / CB Scheme 7
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5

Similar threads

Top Bottom