Putting a new IVD on the market during the transition period

nickie

Starting to get Involved
#1
Hypothetical question from my Managing Director! If we were to put a new IVD on the market for professional use that we are currently able to self certify, but that would need the input from a NB once the new regulations are in place, can we still self certify during the five year transition period, or do we have to be compliant with the new regulations from when they become law and involve a NB?
 
Elsmar Forum Sponsor
S

Sarah Stec

#2
Tl;dr: You could place them on the market now, but that doesn't mean you don't have any work to do now.

You may want to be careful about a couple things (incomplete list):

- The end dates of the various transition periods: different provisions of the IVDR will be enforced before the final deadline, so you may want to double-check these provisions to ensure you maintain compliance.

- Certification transition dates: It's my understanding you would need your EC Certificate in hand on the application date to continue selling (i.e. be audited by a notified body before the application date so that you can fix any issues and possibly get your certificate before the application date). Getting caught in the scramble at the end and possibly losing some time on the market while you wait for your audits to be done/certificates to come in could be stressful. :2cents:

Moral of the story: if you do want to go this route, you may want to plan it out so that your transition to the new IVDR is as seamless as possible. So, even if you can be self-certify now, it's probably a good idea to start building your IVDR-compliant systems and documents now so you can be ready to go.

:bigwave:
 
H

HeatherC-S

#3
I was on the assumption that the transition period would still be true for putting a new device on the market. Our IVD wont be ready until June so we were working on the basis that we could still self-certify. However, I spoke to a consultant at Emergo a couple of days ago and was informed that this wasn't the case and we would need to get it done by May BEFORE the new IVDR comes into force.
 
M

missjenny

#4
Heather,

Did the Emergo Consultant provide you with a reference or a basis for that claim? I am asking because I was under the same assumption that you are allowed to place new devices out on the market under the old directive during the transition period.
 

chris1price

Trusted Information Resource
#5
I agree with Jenny, I thought self-certificatoins were valid until the end of the transition period, irrespective of when they are generated. I did pull out the latest IVD-R text, I can't find anywhere where it says so in writing. It describes the transition for normal certificates, but not self-certification.

However, I believe as soon as the transition ends, all self-cerification would be invalid. At that time you would have to find a NB and have then perform the nescessary Technical File reviews before you could apply a new CE Mark and continue selling.

If anyone knows for sure, I'd also like to know the reference.

Chris
 
Thread starter Similar threads Forum Replies Date
Watchcat When to begin putting together postmarket production QMS for a mobile app? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
2 GDT of datums - Putting Datum C on a drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
R Putting a Supplier on Probation Supplier Quality Assurance and other Supplier Issues 12
M Putting the CE Mark on Product Brochures and Posters CE Marking (Conformité Européene) / CB Scheme 12
M Putting Quality Management Together - Getting People to see Quality as a System Quality Manager and Management Related Issues 12
S Putting Data Macros in a Form Fields - Access 2010 Quality Assurance and Compliance Software Tools and Solutions 5
N Putting SOPs in place in preparation for ISO certification - where to start? Service Industry Specific Topics 5
M Putting First Pieces with Masters - Need opinions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
1 Putting Quality in place before shipping product Quality Manager and Management Related Issues 18
R Registrar Auditor putting more emphasis on training? ISO9001:2008 General Auditing Discussions 8
K Putting a regulated device on the market without the proper ISO Certs and CE Marking EU Medical Device Regulations 9
N Combining two time series graphs and putting a break line between them Using Minitab Software 5
G Manufacturing Aide - Putting a "Manufacturing Aide or note" on a customer print? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Industry Week is putting on a Free Lean Accounting webcast Lean in Manufacturing and Service Industries 0
Marc Putting the Cat Out - Love Your Cat Funny Stuff - Jokes and Humour 8
Q Key Quality Metrics - Manufacturing - Putting together a scorecard Quality Tools, Improvement and Analysis 27
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 0
S Registration of IVD in South Africa Other Medical Device Regulations World-Wide 2
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
R RUO and IVD Medical Device and FDA Regulations and Standards News 1
M UDI IVD - before submission? US Food and Drug Administration (FDA) 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
BusyBee IVD components supplied in bulk CE Marking (Conformité Européene) / CB Scheme 1
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
M Labeling IVD Class III Medical Device and FDA Regulations and Standards News 0
R IVD Label Change China Medical Device Regulations 1
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
D IVD Accuracy and Precision Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 1
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 0
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
S CE Marking components within IVD CE Marking (Conformité Européene) / CB Scheme 0
B IVD - GSPR checklist Other Medical Device Related Standards 0
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
T CE-IVD mark on packaging EU Medical Device Regulations 1
A Is computing Hardware part of the IVD CE Marking (Conformité Européene) / CB Scheme 3
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
Y Handbook recommended lightcycler for IVD Risk Management Principles and Generic Guidelines 1
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 5
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0

Similar threads

Top Bottom