CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing

Thread Attachment browser
V

vardag

Registered
#1
#1
Hello,

We are an IVD company that is doing Virtual Manufacturing. We are now registering with EU from Ireland for CE Mark. Would we have to register under the old Directive MDD or the new IVDR Regulation (EU) 2017(746). I have downloaded the form and it only has option of selecting only Directive (IVD 98/79/EC) . Please guide us.
 

Attachments

12 questions to ask before buying a QMS
Elsmar Forum Sponsor
Watchcat

Watchcat

Trusted Information Resource
#2
#2
I'm not sure I understand your situation. I'm not familiar with EU registration. I am familiar with CE certification, aka CE Marking.

Are you trying to register your company as an IVD manufacturer? Or are you trying to secure CE certification for one or more of your IVD products?
 
V

vardag

Registered
#3
#3
Watchcat said:
I'm not sure I understand your situation. I'm not familiar with EU registration. I am familiar with CE certification, aka CE Marking.

Are you trying to register your company as an IVD manufacturer? Or are you trying to secure CE certification for one or more of your IVD products?
Click to expand...
We are doing both but plz. give guidance on CE Mark
 
Watchcat

Watchcat

Trusted Information Resource
#4
#4
Here are a couple of links that may help you:

Where are Notified Bodies with their application to the EU IVDR 2017/746?

EU IVDR Regulatory Changes: Overview of Requirements in 2017/746

As far as I know, no NB has yet been designated under the IVDR, so you still can't secure certifcates under the IVDR, only under the IVDD. When you do, you will want to be sure that you understand exactly what those certificates will allow you to do going forward. A lot of the MDD/MDR crowd is now in full panic, because only two NBs have been designated under the MDR and their critical dates are coming up much sooner than those for IVD manufacturers, and so far the EC is standing fast on its timelines. There are currently as many rumors as facts floating around the internet.

If you are going to try to DIY this, you are going to have to do a ton of reading, not just rely on guidance in forums like this. If RA isn't your primary area of expertise/responsibility, the DIY approach probably won't end well for your company. Sadly, things may not end well for a lot of companies, no matter what they do. No amount of expertise will get you a certificate if there are no NBs available to issue them.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
G UVC sterilizer CE Mark CE Marking (Conformité Européene) / CB Scheme 4
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
A CE Mark and PMCF study EU Medical Device Regulations 3
T CE mark start date for a device EU Medical Device Regulations 7
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
S CE Mark - Classification Confusion EU Medical Device Regulations 12
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 17
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
A CE mark - Measuring Instruments Directive confusion! CE Marking (Conformité Européene) / CB Scheme 0
S CE mark on a medical device - Textile product CE Marking (Conformité Européene) / CB Scheme 2
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
S Can we still manufacture whilst awaiting return of our CE Mark? Other Medical Device Related Standards 1
J EC REP information and CE Mark - Component of a system that is not a medical device EU Medical Device Regulations 2
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
B Do CE Mark associations exist? CE Marking (Conformité Européene) / CB Scheme 1
E EU Class 1s CE Mark Regulatory Pathway EU Medical Device Regulations 9
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
Ronen E RIP Mark Hollis 1955-2019 Coffee Break and Water Cooler Discussions 0
M CE mark validity after Brexit, 29th March '19 EU Medical Device Regulations 6
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
A CE Mark PPE Category III for our customers residing in the EU CE Marking (Conformité Européene) / CB Scheme 1
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
D US Made class I CE Mark product for export only to EU Other US Medical Device Regulations 4
M ISO 13485 Required for CE Mark on Class I product CE Marking (Conformité Européene) / CB Scheme 1
O Private label issues For EU - Customer does not have CE Mark CE Marking (Conformité Européene) / CB Scheme 7
C Addition of Design & Manufacture - CE Mark Reissue? EU Medical Device Regulations 1
I IEC 60601 and the UL mark 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D CE Mark with same NB (Notified Body)? CE Marking (Conformité Européene) / CB Scheme 4
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
E IVD Vials - If we CE Mark a kit's package, do we also have to CE Mark the vials? CE Marking (Conformité Européene) / CB Scheme 4
R ISO 13485 Certification and then CE Mark? EU Medical Device Regulations 8
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6

Similar threads

Top Bottom