Putting a new IVD on the market during the transition period


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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?
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Sarah Stec

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.



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.



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.


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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.

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