Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

My understanding has been that if the test is still valid and meets current standard requirements and the requirements of the MDR it would be ok and wouldn't need to be re-executed. If the testing is no longer valid under a recently revised version of a standard, it would need to be evaluated to determine if the testing should be re-done. 

Anything already on the market was manufactured and sold under a MDD certificate so I don't believe MDR requirements can apply to devices placed on the market before then.

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Allyson Swartz
Quality Engineer II
Coralville IA
United States
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Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

This message was posted by a user wishing to remain anonymous

Of course the test certificate is valid, but it may not be useful.

If you are placing a device on the market (e.g. offering it for sale), regardless of when it was actually manufactured, does it have safety according to the state of the art? This question is relevant under MDD and MDR.

If you tested in 2010 to EN 60601-1-2:2007, when it was harmonized, it offered a presumption of conformity to the EMC safety requirements. But on 31/12/2018, it ceased to offer that presumption of conformity. If you wanted to sell the device into the EU after that date, most likely you would have tested to the new harmonized standard, EN 60601-1-2:2015.

Under the MDR, same as MDD, you might have trouble explaining why testing to an old international standard would demonstrate safety as well as or better than testing to the current, presumably improved, standard.
Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

Hello, 

The presumption of conformity to the State of the Art comes from the MDD as well as MDR. However, this applies if the device continues to be offered for Sale in the EU post the transition date. If the device that was tested in 2010 is not longer offered for sale in the EU after the effective date of EU MDR, then that device can remain on the market until the end of its expected life - but cannot be offered for sale to new customers. 

On a separate note, in certain situations, you can offer a device CE marked per the MDD conformity assessment procedures for sale in the EU until May 2024, as long as you have a valid EC certificate for the duration of the transition period, i.e. until May 2024; AND you do not do any significant changes that require NB review during that period. Of course, this only applies to Class IIa or higher products that have an EC certificate - so Class I devices per MDD cannot avail of this "soft transition" since they did not require EC certification and were placed on market under the sole authority of the manufacturer. 

Hope this helps!

------------------------------
Manan Hathi RAC
Sr. Staff Regulatory Affairs Specialist
Flower Mound TX
United States
------------------------------

Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

First, some picky points.

I recommend not using the term "legacy device". It has multiple meanings and is creating confusion. A device could be in one of three states: full MDD, MDR Article 120, or full MDR. I recommend naming the states.

There is no grandfathering in the MDR implementation so it doesn't end.

The overall strategy is to determine the Annex I requirements that apply and then determine how you will demonstrate device conformity. The common approach is to use a standard. If the standard applies then the date of testing is not a concern; the test data does not expire because of the MDR date.

There is another potential issue however. Under the MDD, manufacturers made a separate declaration of conformity for each applicable directive or regulation. Under the MDR, there is a different system. The manufacturer makes one declaration of conformity for all applicable directives and regulations.

As an example, I'm working with a client for which the device requires MDR, the EMC directive, and the RoHS directive. Each requires a declaration, so we are combining them into one. Also, the two regulations have harmonized standards, so we are mindful of using them and ensure we can support their use with objective evidence.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

This message was posted by a user wishing to remain anonymous

Thank you everyone, your thoughts and insights are really appreciated. 

Dan, you said that under the MDR, unlike in the MDD, the manufacturer makes one declaration of conformity for all applicable directives and regulations. Where could I find this in the MDR text? Are we talking about a "can make" or "shall make" type of thing?
Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

See Article 19(2). It says, "a single EU declaration of conformity shall be drawn up". The single DoC is subject to translation requirements in Aticle 19(1).

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 29-Oct-2019 08:36
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Thank you everyone, your thoughts and insights are really appreciated.

Dan, you said that under the MDR, unlike in the MDD, the manufacturer makes one declaration of conformity for all applicable directives and regulations. Where could I find this in the MDR text? Are we talking about a "can make" or "shall make" type of thing?
Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.

This message was posted by a user wishing to remain anonymous

Got it Dan. A single declaration of conformity is applicable when devices are subject to other Union legislation (other than EU MDR) which also requires an EU declaration of conformity.
Original Message:
Sent: 29-Oct-2019 18:51
From: Dan O'Leary
Subject: EU MDR legacy devices compliance

See Article 19(2). It says, "a single EU declaration of conformity shall be drawn up". The single DoC is subject to translation requirements in Aticle 19(1).

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 29-Oct-2019 08:36
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Thank you everyone, your thoughts and insights are really appreciated.

Dan, you said that under the MDR, unlike in the MDD, the manufacturer makes one declaration of conformity for all applicable directives and regulations. Where could I find this in the MDR text? Are we talking about a "can make" or "shall make" type of thing?
Original Message:
Sent: 22-Oct-2019 05:00
From: Anonymous Member
Subject: EU MDR legacy devices compliance

This message was posted by a user wishing to remain anonymous

Hello,

Does the end of grandfathering for legacy devices under EU MDR mean that if a medical device has been tested let's say in 2010 for EMC and has been on the market ever since, the test needs to be made again to ensure EU MDR compliance, or is the 2010 test certificate still valid after 26.5.2020?

Does it make any difference if the device is no longer manufactured, but devices continue to be on the market after 26.5.2020?

I would really appreciate your comments on this.