Regulatory Open Forum

Hello All,

I have received conflicting information on the IVDR enforcement dates for NEW IVDs.  I'd like some clarity.  Under IVDD, we self-certify all of our production.  Under IVDR, most of our products will be Class B and therefore require Notified Body.   If we would like to CE-mark a new IVD next year, can we following the IVDD method of self-certifying?  Can we continue to self-certify until the 2022 deadline for compliance with IVDR. 

I have been told by our Authorized Representative that we can self-certify until 2022 but I have heard from other sources that starting May 2018, we can no longer self-certify.

Any clarity and information is greatly appreciated!

Thanks,
Joy

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Joy Pelfrey
Director of RA/QA
Norman OK
United States
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This message was posted by a user wishing to remain anonymous

Hello Joy,

Here's some clarification on IVDR timelines - 

- IVDR will be applicable from 26 May 2022. 
- IVDD certs will be valid from 26 May 2017 - 25 May 2022, meaning that IVDD certs can be issued as per current regulations during this period. 
- IVDD certs will no longer be valid from 25 May 2024. However, the devices under IVDD can remain available on the market until 25 May 2025 (which I'd say is the STOP sign for all IVDD devices). 

Hence, my understanding would be that devices can be CE marked as per current regulations until 25 May 2022 (if your project plan allows). I'd recommend interpreting Art. 113 in detail which provides clarification on timelines. 

Hope this helps!
Original Message:
Sent: 24-Oct-2017 10:46
From: Joy Pelfrey
Subject: IVDR enforcement dates

Hello All,

I have received conflicting information on the IVDR enforcement dates for NEW IVDs.  I'd like some clarity.  Under IVDD, we self-certify all of our production.  Under IVDR, most of our products will be Class B and therefore require Notified Body.   If we would like to CE-mark a new IVD next year, can we following the IVDD method of self-certifying?  Can we continue to self-certify until the 2022 deadline for compliance with IVDR.

I have been told by our Authorized Representative that we can self-certify until 2022 but I have heard from other sources that starting May 2018, we can no longer self-certify.

Any clarity and information is greatly appreciated!

Thanks,
Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

I've recast your questions so they fit into the framework of the regulation. Also, these dates are for the IVDR. The corresponding dates for the MDR are different.

 

What is the last date a company may put the CE Mark on a new product under the IVDD?

This is the date of application from Article 113 as May 26, 2022.

 

What is the first date a company may put the CE Mark on a new product under the IVDR?

Technically, it is the date of Entry into Force from Article 113 as May 26, 2017.

Practically, if the device requires a Notified Body it will be much later, since there are no Notified Bodies for the IVDR. A company cannot apply to be a Notified Body before Nov. 26, 2017. It will take 6 to 9 months for the first one to complete the process.

 

How long can a manufacturer keep a device on the market under the IVDD before it must come under the IVDR?

Certificates issued by Notified Bodies in accordance under the IVDR before May 25, 2017 are valid until the end of the certificate.  However, if the certificate is to Annex VI, it is void on May 27, 2024. [Article 110(2)]

 

Devices lawfully placed on the market under the IVDD (without an NB) before May 26, 2022 may stay on the market until May 27, 2025. [Article 110(4)]

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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 24-Oct-2017 10:46
From: Joy Pelfrey
Subject: IVDR enforcement dates

Hello All,

I have received conflicting information on the IVDR enforcement dates for NEW IVDs.  I'd like some clarity.  Under IVDD, we self-certify all of our production.  Under IVDR, most of our products will be Class B and therefore require Notified Body.   If we would like to CE-mark a new IVD next year, can we following the IVDD method of self-certifying?  Can we continue to self-certify until the 2022 deadline for compliance with IVDR.

I have been told by our Authorized Representative that we can self-certify until 2022 but I have heard from other sources that starting May 2018, we can no longer self-certify.

Any clarity and information is greatly appreciated!

Thanks,
Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Hi Joy,

My understanding is that you currently self-declare under the IVDD without Notified Body intervention and under the IVDR your devices will up-classified to class B requiring Notified Body certificates.

I understand that you will still have the option to continue to self-declare for CE Marking under the IVDD until May 2022. Because you do not have current Notified Body issued CE Marking certificates there is no further transition period and you must comply with IVDR class B requirements from May 2022 (must have a Notified Body certificate in place).

Note a lot of IVD manufacturers are in the same boat and it is anticipated there could be significant backlogs in Notified Body capacity towards May 2022, so, I would plan on transitioning much earlier than 2022. It is also possible that the market gets sensitive to the new requirements and purchasers/tenders start requiring products meeting the latest regulatory requirements (IVDR).    
 
Hope this helps.

Paul

------------------------------
Paul Brooks
Executive Director
RAPS
Rockville MD
United States
------------------------------

Original Message:
Sent: 24-Oct-2017 10:46
From: Joy Pelfrey
Subject: IVDR enforcement dates

Hello All,

I have received conflicting information on the IVDR enforcement dates for NEW IVDs.  I'd like some clarity.  Under IVDD, we self-certify all of our production.  Under IVDR, most of our products will be Class B and therefore require Notified Body.   If we would like to CE-mark a new IVD next year, can we following the IVDD method of self-certifying?  Can we continue to self-certify until the 2022 deadline for compliance with IVDR.

I have been told by our Authorized Representative that we can self-certify until 2022 but I have heard from other sources that starting May 2018, we can no longer self-certify.

Any clarity and information is greatly appreciated!

Thanks,
Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Thank you everyone for the clarification!  This helps tremendously.

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------

Original Message:
Sent: 25-Oct-2017 16:36
From: Paul Brooks
Subject: IVDR enforcement dates

Hi Joy,

My understanding is that you currently self-declare under the IVDD without Notified Body intervention and under the IVDR your devices will up-classified to class B requiring Notified Body certificates.

I understand that you will still have the option to continue to self-declare for CE Marking under the IVDD until May 2022. Because you do not have current Notified Body issued CE Marking certificates there is no further transition period and you must comply with IVDR class B requirements from May 2022 (must have a Notified Body certificate in place).

Note a lot of IVD manufacturers are in the same boat and it is anticipated there could be significant backlogs in Notified Body capacity towards May 2022, so, I would plan on transitioning much earlier than 2022. It is also possible that the market gets sensitive to the new requirements and purchasers/tenders start requiring products meeting the latest regulatory requirements (IVDR).

Hope this helps.

Paul

------------------------------
Paul Brooks
Executive Director
RAPS
Rockville MD
United States

Original Message:
Sent: 24-Oct-2017 10:46
From: Joy Pelfrey
Subject: IVDR enforcement dates

Hello All,

I have received conflicting information on the IVDR enforcement dates for NEW IVDs.  I'd like some clarity.  Under IVDD, we self-certify all of our production.  Under IVDR, most of our products will be Class B and therefore require Notified Body.   If we would like to CE-mark a new IVD next year, can we following the IVDD method of self-certifying?  Can we continue to self-certify until the 2022 deadline for compliance with IVDR.

I have been told by our Authorized Representative that we can self-certify until 2022 but I have heard from other sources that starting May 2018, we can no longer self-certify.

Any clarity and information is greatly appreciated!

Thanks,
Joy

------------------------------
Joy Pelfrey
Director of RA/QA
Norman OK
United States
------------------------------