Regulatory Open Forum

Hello all, 

After re-reading articles in the IVDR, I'm probably bringing up a point that will spark a few mixed reactions concerning the DofA for IVDR products of those in the IVD field. 

In particular, the DofA for products that are currently outside List A / List B of Annex II of the IVD (other wise known as auto or self certified) products AND remain Class A under the IVDR.

The IVDR speaks principally of DofA for certificates (ie issued by Notified Bodies).... and there is no clear explication / positioning of auto / self certified devices (accessories) ... 
It's by far the majority of accessories & instruments (Rule 5) that remain in Class A.... 

The only point I consider covering more or less the self certified devices in the IVDR is the Article 110 §4, which says... 
"4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025". 

So one way of reading this is : 
"Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022" 
....
"may continue to be made available on the market or put into service until 27 May 2025"

In other words, devices that are compliant to the Directive (ie have a DofC), which obviously includes outside List A / B devices may continue to be made available on the market until 2025...
And of course it doesn't indicate for the duration of validity of the Declaration of Conformity... 
And yes I know this is not the opinion of many.... 

Many documents (including EU published ones & others ) have focused on devices having certificates issued by Notified Bodies & their associated timelines ... but nothing clearly indicates the IVDR text which says what is (or is not) possible for devices that are outside Annex A/B and remain in Class A under the IVDR. 
Which leaves an opening to discussion... 

I hope my description is clear... I'd appreciate feedback, not only opinions, but above all a clear link / association with the text in the IVDR.

Thanks in advance. 

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Hello Tim,

The entirety of Article 110 needs to be read and not just a sentence or two.  Basically if an organisation has a current IVDD certificate, this can be renewed for a transition period out to May 2024.  Those products which change classification under the IVDR need to be treated under the requirements of the regulation after May 2022.

Those products outside List A/List B or having no Notified Body review, e.g. no IVDD certificate, must have a CE Certificate to EU IVDR in order to place on the market after 26 May 2022.  This is the real issue and concern right now there are so many IVD products which need IVDR CE Certificates, review by a Notified Body, which are Class B, C, and D with only one year left.

Class A devices are self-declare, so they require no Notified Body intervention.  However, they still need to comply by 26 May 2022 compliance date - they would not fall under Article 110 because they have no IVDD certificate which can be renewed.  After 26 May 2022, Class A devices placed on the market need a QMS and Technical Documentation.  An inspection by a local Competent Authority could occur or a request for technical documentation made, so this should be available.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
------------------------------

Original Message:
Sent: 17-May-2021 04:50
From: Tim Lawton
Subject: IVDR transition provisions (for Class A)

Hello all,

After re-reading articles in the IVDR, I'm probably bringing up a point that will spark a few mixed reactions concerning the DofA for IVDR products of those in the IVD field.

In particular, the DofA for products that are currently outside List A / List B of Annex II of the IVD (other wise known as auto or self certified) products AND remain Class A under the IVDR.

The IVDR speaks principally of DofA for certificates (ie issued by Notified Bodies).... and there is no clear explication / positioning of auto / self certified devices (accessories) ...
It's by far the majority of accessories & instruments (Rule 5) that remain in Class A....

The only point I consider covering more or less the self certified devices in the IVDR is the Article 110 §4, which says...
"4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025".

So one way of reading this is :
"Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022"
....
"may continue to be made available on the market or put into service until 27 May 2025"

In other words, devices that are compliant to the Directive (ie have a DofC), which obviously includes outside List A / B devices may continue to be made available on the market until 2025...
And of course it doesn't indicate for the duration of validity of the Declaration of Conformity...
And yes I know this is not the opinion of many....

Many documents (including EU published ones & others ) have focused on devices having certificates issued by Notified Bodies & their associated timelines ... but nothing clearly indicates the IVDR text which says what is (or is not) possible for devices that are outside Annex A/B and remain in Class A under the IVDR.
Which leaves an opening to discussion...

I hope my description is clear... I'd appreciate feedback, not only opinions, but above all a clear link / association with the text in the IVDR.

Thanks in advance.

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Hi Tim, 

Art. 110.2 says that Notified Body certificates, issued under the Directive, remain valid until May 2024. This means that the manufacturer can still continue to manufacture batches of products and place them on the market in compliance with the IVD Directive after May 2022 and until May 2024 (or until the expiry of the certificate, whatever comes first). 
With respect to devices without Notified Body certificate, Art. 110.4 says that devices that have been placed on the market prior to May 2022 may continue to be made available on the market until May 2025 (if the expiry date of the product allows). The key here is "have been placed on the market". There is guidance on what that exactly means but it essentially means that the devices must have been imported into the EU (if manufactured ex-EU) or have changed ownership (if manufactured in the EU). Those devices can be further sold down the supply chain to distributors, users, ...  until May 2025. That applies to devices that will be in Class A under the IVDR and higher classified products alike.
The difference with art. 110.2 is that the manufacturer cannot manufacture and place on the market devices after May 2022 without complying to the IVDR. Even though there is no need for a Notified Body certificate, there are plenty of new requirements in the IVDR that also apply to Class A and would require manufacturers to take action. Competent authorities may check on manufacturers as part of their market surveillance activities, indeed. 
Art. 110.2 extends the transition period for manufacturing, releasing devices and placing them on the market beyond May 2022. Art. 110.4 only extends the transition period of the devices that have been been manufactured and placed on the market before May 2022. (Batches of) devices, manufactured after May 2022 must be manufactured in compliance with the IVDR.

------------------------------
Dirk Stynen PhD
President
QARAD
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu
------------------------------

Original Message:
Sent: 18-May-2021 05:23
From: Richard Vincins
Subject: IVDR transition provisions (for Class A)

Hello Tim,

The entirety of Article 110 needs to be read and not just a sentence or two.  Basically if an organisation has a current IVDD certificate, this can be renewed for a transition period out to May 2024.  Those products which change classification under the IVDR need to be treated under the requirements of the regulation after May 2022.

Those products outside List A/List B or having no Notified Body review, e.g. no IVDD certificate, must have a CE Certificate to EU IVDR in order to place on the market after 26 May 2022.  This is the real issue and concern right now there are so many IVD products which need IVDR CE Certificates, review by a Notified Body, which are Class B, C, and D with only one year left.

Class A devices are self-declare, so they require no Notified Body intervention.  However, they still need to comply by 26 May 2022 compliance date - they would not fall under Article 110 because they have no IVDD certificate which can be renewed.  After 26 May 2022, Class A devices placed on the market need a QMS and Technical Documentation.  An inspection by a local Competent Authority could occur or a request for technical documentation made, so this should be available.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 17-May-2021 04:50
From: Tim Lawton
Subject: IVDR transition provisions (for Class A)

Hello all,

After re-reading articles in the IVDR, I'm probably bringing up a point that will spark a few mixed reactions concerning the DofA for IVDR products of those in the IVD field.

In particular, the DofA for products that are currently outside List A / List B of Annex II of the IVD (other wise known as auto or self certified) products AND remain Class A under the IVDR.

The IVDR speaks principally of DofA for certificates (ie issued by Notified Bodies).... and there is no clear explication / positioning of auto / self certified devices (accessories) ...
It's by far the majority of accessories & instruments (Rule 5) that remain in Class A....

The only point I consider covering more or less the self certified devices in the IVDR is the Article 110 §4, which says...
"4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025".

So one way of reading this is :
"Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022"
....
"may continue to be made available on the market or put into service until 27 May 2025"

In other words, devices that are compliant to the Directive (ie have a DofC), which obviously includes outside List A / B devices may continue to be made available on the market until 2025...
And of course it doesn't indicate for the duration of validity of the Declaration of Conformity...
And yes I know this is not the opinion of many....

Many documents (including EU published ones & others ) have focused on devices having certificates issued by Notified Bodies & their associated timelines ... but nothing clearly indicates the IVDR text which says what is (or is not) possible for devices that are outside Annex A/B and remain in Class A under the IVDR.
Which leaves an opening to discussion...

I hope my description is clear... I'd appreciate feedback, not only opinions, but above all a clear link / association with the text in the IVDR.

Thanks in advance.

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Dirk,

Thank you for the explanation of "placing on the market" because indeed that is really important to understand that point - as example product being in inventory at a distributor up to an expiration date.  That is very helpful clarification based on my short response.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
------------------------------

Original Message:
Sent: 18-May-2021 07:42
From: Dirk Stynen
Subject: IVDR transition provisions (for Class A)

Hi Tim,

Art. 110.2 says that Notified Body certificates, issued under the Directive, remain valid until May 2024. This means that the manufacturer can still continue to manufacture batches of products and place them on the market in compliance with the IVD Directive after May 2022 and until May 2024 (or until the expiry of the certificate, whatever comes first).
With respect to devices without Notified Body certificate, Art. 110.4 says that devices that have been placed on the market prior to May 2022 may continue to be made available on the market until May 2025 (if the expiry date of the product allows). The key here is "have been placed on the market". There is guidance on what that exactly means but it essentially means that the devices must have been imported into the EU (if manufactured ex-EU) or have changed ownership (if manufactured in the EU). Those devices can be further sold down the supply chain to distributors, users, ...  until May 2025. That applies to devices that will be in Class A under the IVDR and higher classified products alike.
The difference with art. 110.2 is that the manufacturer cannot manufacture and place on the market devices after May 2022 without complying to the IVDR. Even though there is no need for a Notified Body certificate, there are plenty of new requirements in the IVDR that also apply to Class A and would require manufacturers to take action. Competent authorities may check on manufacturers as part of their market surveillance activities, indeed.
Art. 110.2 extends the transition period for manufacturing, releasing devices and placing them on the market beyond May 2022. Art. 110.4 only extends the transition period of the devices that have been been manufactured and placed on the market before May 2022. (Batches of) devices, manufactured after May 2022 must be manufactured in compliance with the IVDR.

------------------------------
Dirk Stynen PhD
President
QARAD
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu

Original Message:
Sent: 18-May-2021 05:23
From: Richard Vincins
Subject: IVDR transition provisions (for Class A)

Hello Tim,

The entirety of Article 110 needs to be read and not just a sentence or two.  Basically if an organisation has a current IVDD certificate, this can be renewed for a transition period out to May 2024.  Those products which change classification under the IVDR need to be treated under the requirements of the regulation after May 2022.

Those products outside List A/List B or having no Notified Body review, e.g. no IVDD certificate, must have a CE Certificate to EU IVDR in order to place on the market after 26 May 2022.  This is the real issue and concern right now there are so many IVD products which need IVDR CE Certificates, review by a Notified Body, which are Class B, C, and D with only one year left.

Class A devices are self-declare, so they require no Notified Body intervention.  However, they still need to comply by 26 May 2022 compliance date - they would not fall under Article 110 because they have no IVDD certificate which can be renewed.  After 26 May 2022, Class A devices placed on the market need a QMS and Technical Documentation.  An inspection by a local Competent Authority could occur or a request for technical documentation made, so this should be available.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 17-May-2021 04:50
From: Tim Lawton
Subject: IVDR transition provisions (for Class A)

Hello all,

After re-reading articles in the IVDR, I'm probably bringing up a point that will spark a few mixed reactions concerning the DofA for IVDR products of those in the IVD field.

In particular, the DofA for products that are currently outside List A / List B of Annex II of the IVD (other wise known as auto or self certified) products AND remain Class A under the IVDR.

The IVDR speaks principally of DofA for certificates (ie issued by Notified Bodies).... and there is no clear explication / positioning of auto / self certified devices (accessories) ...
It's by far the majority of accessories & instruments (Rule 5) that remain in Class A....

The only point I consider covering more or less the self certified devices in the IVDR is the Article 110 §4, which says...
"4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025".

So one way of reading this is :
"Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022"
....
"may continue to be made available on the market or put into service until 27 May 2025"

In other words, devices that are compliant to the Directive (ie have a DofC), which obviously includes outside List A / B devices may continue to be made available on the market until 2025...
And of course it doesn't indicate for the duration of validity of the Declaration of Conformity...
And yes I know this is not the opinion of many....

Many documents (including EU published ones & others ) have focused on devices having certificates issued by Notified Bodies & their associated timelines ... but nothing clearly indicates the IVDR text which says what is (or is not) possible for devices that are outside Annex A/B and remain in Class A under the IVDR.
Which leaves an opening to discussion...

I hope my description is clear... I'd appreciate feedback, not only opinions, but above all a clear link / association with the text in the IVDR.

Thanks in advance.

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Hi Tim,

I understand this is also explained im the FAQ - IVDR Transitional provisions from CAMD
https://ec.europa.eu/growth/content/faq-%E2%80%93-ivdr-transitional-provisions_en
Page 11 - Question 16: What is the so called "sell off" provision (Art. 110 para 4 IVDR) about?
Answer from the FAQ:
"It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor.
After May 27, 2025 these devices may not be made available/put into service (= deadline). If such devices are still within the supply chain by this date - i.e. have not reached the final user as being ready for use (e.g. the hospital) - they are not "marketable" any more.
This provision is thus primarily dealing with the "making available" of IVDD compliant devices once they have been placed on the market, e.g. within the supply chain. It does not apply to the "placing on the market" of these devices by the MFR.
Please also note, that this provision is not intended to apply to second hand sales (see recital 3). This means, once a device has been made available to the final user (e.g. the hospital) as being ready for use, the further making available of this device is not subject to/covered by the IVDR."

I understand that Art. 110 §4 would not apply to manufacturers based in the EU, but would apply to the rest of the supply chain in EU.

Any other opinions?

Thanks and Kind Regards,
Claudia 



------------------------------
Claudia Solimeo Meneghisse RAC, PhD
Senior Regulatory Affairs Manager
Tecan Schweiz AG
Männedorf
Switzerland
------------------------------

Original Message:
Sent: 17-May-2021 04:50
From: Tim Lawton
Subject: IVDR transition provisions (for Class A)

Hello all,

After re-reading articles in the IVDR, I'm probably bringing up a point that will spark a few mixed reactions concerning the DofA for IVDR products of those in the IVD field.

In particular, the DofA for products that are currently outside List A / List B of Annex II of the IVD (other wise known as auto or self certified) products AND remain Class A under the IVDR.

The IVDR speaks principally of DofA for certificates (ie issued by Notified Bodies).... and there is no clear explication / positioning of auto / self certified devices (accessories) ...
It's by far the majority of accessories & instruments (Rule 5) that remain in Class A....

The only point I consider covering more or less the self certified devices in the IVDR is the Article 110 §4, which says...
"4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025".

So one way of reading this is :
"Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022"
....
"may continue to be made available on the market or put into service until 27 May 2025"

In other words, devices that are compliant to the Directive (ie have a DofC), which obviously includes outside List A / B devices may continue to be made available on the market until 2025...
And of course it doesn't indicate for the duration of validity of the Declaration of Conformity...
And yes I know this is not the opinion of many....

Many documents (including EU published ones & others ) have focused on devices having certificates issued by Notified Bodies & their associated timelines ... but nothing clearly indicates the IVDR text which says what is (or is not) possible for devices that are outside Annex A/B and remain in Class A under the IVDR.
Which leaves an opening to discussion...

I hope my description is clear... I'd appreciate feedback, not only opinions, but above all a clear link / association with the text in the IVDR.

Thanks in advance.

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Thanks for the great clarifications & much appreciated - its certainly going to be an interesting time for many ivd & ivd accessory manufacturers... 

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Original Message:
Sent: 18-May-2021 15:42
From: Claudia Solimeo Meneghisse
Subject: IVDR transition provisions (for Class A)

Hi Tim,

I understand this is also explained im the FAQ - IVDR Transitional provisions from CAMD
https://ec.europa.eu/growth/content/faq-%E2%80%93-ivdr-transitional-provisions_en
Page 11 - Question 16: What is the so called "sell off" provision (Art. 110 para 4 IVDR) about?
Answer from the FAQ:
"It is intended to limit the time during which IVDD compliant devices, that have already been placed on the market (either before the DoA or by virtue of Art. 110 para 3 after the DoA), may be made available e.g. by a distributor.
After May 27, 2025 these devices may not be made available/put into service (= deadline). If such devices are still within the supply chain by this date - i.e. have not reached the final user as being ready for use (e.g. the hospital) - they are not "marketable" any more.
This provision is thus primarily dealing with the "making available" of IVDD compliant devices once they have been placed on the market, e.g. within the supply chain. It does not apply to the "placing on the market" of these devices by the MFR.
Please also note, that this provision is not intended to apply to second hand sales (see recital 3). This means, once a device has been made available to the final user (e.g. the hospital) as being ready for use, the further making available of this device is not subject to/covered by the IVDR."

I understand that Art. 110 §4 would not apply to manufacturers based in the EU, but would apply to the rest of the supply chain in EU.

Any other opinions?

Thanks and Kind Regards,
Claudia



------------------------------
Claudia Solimeo Meneghisse RAC, PhD
Senior Regulatory Affairs Manager
Tecan Schweiz AG
Männedorf
Switzerland

Original Message:
Sent: 17-May-2021 04:50
From: Tim Lawton
Subject: IVDR transition provisions (for Class A)

Hello all,

After re-reading articles in the IVDR, I'm probably bringing up a point that will spark a few mixed reactions concerning the DofA for IVDR products of those in the IVD field.

In particular, the DofA for products that are currently outside List A / List B of Annex II of the IVD (other wise known as auto or self certified) products AND remain Class A under the IVDR.

The IVDR speaks principally of DofA for certificates (ie issued by Notified Bodies).... and there is no clear explication / positioning of auto / self certified devices (accessories) ...
It's by far the majority of accessories & instruments (Rule 5) that remain in Class A....

The only point I consider covering more or less the self certified devices in the IVDR is the Article 110 §4, which says...
"4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025".

So one way of reading this is :
"Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022"
....
"may continue to be made available on the market or put into service until 27 May 2025"

In other words, devices that are compliant to the Directive (ie have a DofC), which obviously includes outside List A / B devices may continue to be made available on the market until 2025...
And of course it doesn't indicate for the duration of validity of the Declaration of Conformity...
And yes I know this is not the opinion of many....

Many documents (including EU published ones & others ) have focused on devices having certificates issued by Notified Bodies & their associated timelines ... but nothing clearly indicates the IVDR text which says what is (or is not) possible for devices that are outside Annex A/B and remain in Class A under the IVDR.
Which leaves an opening to discussion...

I hope my description is clear... I'd appreciate feedback, not only opinions, but above all a clear link / association with the text in the IVDR.

Thanks in advance.

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------