Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
I have a question about when a new MDR certificate for legacy MDD devices would be required. 

Assuming we have a valid Full Quality Assurance certificate and Design Examination certificate issued under the MDD for a shoulder implant, and they expire several years after May 2020. If we submit an MDR application for a new shoulder implant device, would this require all of our shoulder implants to be fully MDR compliant (e.g. obtain a MDR certificate) immediately, or would we still be able to use the full grace period under Article 120?

This question arises because we know that we are not able to have multiple notified bodies for the same device type, so would the same logic apply to make it impermissible to have the same device type under both the MDD and MDR?

We've asked the same question to our notified body. We do not yet have an answer regarding whether we'll be able to MDR certify an entire family at once with one product being our representative. We were told that if we audit all product lines at once to MDR, unless we hold both an MDD technical file and an MDR technical file, we would be putting all products in potential jeopardy.

------------------------------
Denise Kelly RAC
Senior Regulatory Affairs Specialist
[Guilford] CT
United States
------------------------------

Original Message:
Sent: 05-Nov-2019 14:38
From: Anonymous Member
Subject: EU MDR Transition for Legacy Devices

This message was posted by a user wishing to remain anonymous

Hello,
I have a question about when a new MDR certificate for legacy MDD devices would be required.

Assuming we have a valid Full Quality Assurance certificate and Design Examination certificate issued under the MDD for a shoulder implant, and they expire several years after May 2020. If we submit an MDR application for a new shoulder implant device, would this require all of our shoulder implants to be fully MDR compliant (e.g. obtain a MDR certificate) immediately, or would we still be able to use the full grace period under Article 120?

This question arises because we know that we are not able to have multiple notified bodies for the same device type, so would the same logic apply to make it impermissible to have the same device type under both the MDD and MDR?

In this case, you need to look at Annex IX. Unless you NB has an MDR designation, they are forbidden to answer MDR questions.

Annex IX defines the approach. In summary I believe it is:

Class I devices – N/A

Class IIa devices – Sample the technical documentation on a representative basis

Class IIb devices (except implantable devices) Sample the technical documentation on a representative basis

Class IIb implantable devices – Review the technical documentation for each device

Class III – Review the technical documentation for each device

These rules apply to both the initial audit and the surveillance audits.

I don't see anything in the MDR that says the Annex IX sampling plans for an initial audit must include all MDD or MDR Article 120. From this I infer that technical file sampling for MDR Article 120 devices is independent of technical file sampling for MDR only devices (including the initial audit).

For MDR Article 120 devices, the MDD NB performs the surveillance following the MDD sampling plan.

The basis for the sampling plans in the MDR is not the same as the basis for the sampling plans in MDD, so it would be a technical mistake to combine them.

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

Original Message:
Sent: 07-Nov-2019 09:35
From: Denise Kelly
Subject: EU MDR Transition for Legacy Devices

We've asked the same question to our notified body. We do not yet have an answer regarding whether we'll be able to MDR certify an entire family at once with one product being our representative. We were told that if we audit all product lines at once to MDR, unless we hold both an MDD technical file and an MDR technical file, we would be putting all products in potential jeopardy.

------------------------------
Denise Kelly RAC
Senior Regulatory Affairs Specialist
[Guilford] CT
United States

Original Message:
Sent: 05-Nov-2019 14:38
From: Anonymous Member
Subject: EU MDR Transition for Legacy Devices

This message was posted by a user wishing to remain anonymous

Hello,
I have a question about when a new MDR certificate for legacy MDD devices would be required.

Assuming we have a valid Full Quality Assurance certificate and Design Examination certificate issued under the MDD for a shoulder implant, and they expire several years after May 2020. If we submit an MDR application for a new shoulder implant device, would this require all of our shoulder implants to be fully MDR compliant (e.g. obtain a MDR certificate) immediately, or would we still be able to use the full grace period under Article 120?

This question arises because we know that we are not able to have multiple notified bodies for the same device type, so would the same logic apply to make it impermissible to have the same device type under both the MDD and MDR?

Original Message------

In this case, you need to look at Annex IX. Unless you NB has an MDR designation, they are forbidden to answer MDR questions.

Annex IX defines the approach. In summary I believe it is:

Class I devices – N/A

Class IIa devices – Sample the technical documentation on a representative basis

Class IIb devices (except implantable devices) Sample the technical documentation on a representative basis

Class IIb implantable devices – Review the technical documentation for each device

Class III – Review the technical documentation for each device

These rules apply to both the initial audit and the surveillance audits.

I don't see anything in the MDR that says the Annex IX sampling plans for an initial audit must include all MDD or MDR Article 120. From this I infer that technical file sampling for MDR Article 120 devices is independent of technical file sampling for MDR only devices (including the initial audit).

For MDR Article 120 devices, the MDD NB performs the surveillance following the MDD sampling plan.

The basis for the sampling plans in the MDR is not the same as the basis for the sampling plans in MDD, so it would be a technical mistake to combine them.

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

First, you need to be very clear about what you mean by a legacy product. MDCG 2019-5 says that legacy devices are devices on the market under EU-MDR Article 120, but cautions the term "legacy devices" might have different meanings.

I think it is best to avoid the term "legacy devices" and state the status explicitly: MDD only, MDR Article 120, or MDR only.

Second, having valid certificates under the MDD is necessary but not sufficient for MDR Article 120.

The question, as I understand it, is that you like to have a new device that is MDR only, and other, similar, devices that are MDR Article 120.

I don't see anything in the MDR that prevents a manufacturer from having some devices that are MDR only and some similar devices that are MDR Article 120.

Following Article 52(3) and (4), the NB reviews the technical document for each Class III or Class IIb implantable device. They do not sample, so there is no reason to define a group for sampling, thereby requiring all similar devices to have the same status.

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

Original Message:
Sent: 05-Nov-2019 14:38
From: Anonymous Member
Subject: EU MDR Transition for Legacy Devices

This message was posted by a user wishing to remain anonymous

Hello,
I have a question about when a new MDR certificate for legacy MDD devices would be required.

Assuming we have a valid Full Quality Assurance certificate and Design Examination certificate issued under the MDD for a shoulder implant, and they expire several years after May 2020. If we submit an MDR application for a new shoulder implant device, would this require all of our shoulder implants to be fully MDR compliant (e.g. obtain a MDR certificate) immediately, or would we still be able to use the full grace period under Article 120?

This question arises because we know that we are not able to have multiple notified bodies for the same device type, so would the same logic apply to make it impermissible to have the same device type under both the MDD and MDR?