SBS - The best value in QMS software

IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities?

#1
1. Legal mfg. location USA
2. Contract mfg. location China
3. Authorized Rep. location Germany
4. Notified body TUV

Now, the legal mfg. have EC certificate but it doesn't mention the contract mfg. site in the facilities list. So, is it possible to obtain an annex to the EC from the NB states the CM as one of the facilities?
Please support.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 3
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
G CE marking of MD and IVD set EU Medical Device Regulations 3
D List A IVD - Change to material supplier EU Medical Device Regulations 3
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
J IVD instrument as an accessory EU Medical Device Regulations 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J IVD CE transfer to another manufacturer EU Medical Device Regulations 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
M EU IVD Risk Determination of sample collection EU Medical Device Regulations 0
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
D RUOs in IVD products Other Medical Device and Orthopedic Related Topics 2
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
M IVD Registration - Use of Prospective Study Data Other Medical Device Regulations World-Wide 1
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
I IVD prototypes in EU market ISO 13485:2016 - Medical Device Quality Management Systems 2
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
M IVD - Generating clinical data for IVD’s in the EU EU Medical Device Regulations 2
K Validation of coating plate (IVD) CE Marking (Conformité Européene) / CB Scheme 3
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0
T MDD and IVD comparison Other Medical Device Regulations World-Wide 2
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
ernieto CE marked IVD - Does the "IVD" symbols needs to be in the IFUs? CE Marking (Conformité Européene) / CB Scheme 2
F IVD: Overlabeling in the EU? EU Medical Device Regulations 4
F EU IVD registrations - CFG or CFS - Differences EU Medical Device Regulations 1
N IVD Lot Numbers and Expiration Dates - 21 CFR 809.10 Other US Medical Device Regulations 3

Similar threads

Top Bottom