Regulatory Open Forum

All,

I have a "legacy device," class IIb, as defined in MDCG 2021-25. 

The device has yet to be placed on market in the EU or even advertised, this is due to the business element of the company I am at. Additonally, I have procedures for all the transnational provisions in Article 120. Due to no devices being placed on market or advertised none of those processes have been utilized. Given this information would you expect to the company to have a PMCF plan drawn up or just procedures on how to create a PMCF plan? The same question can apply to the other processes in the Article 120 transitional provisions.

Thank you for any insight provided.

All,

I have a "legacy device," class IIb, as defined in MDCG 2021-25. 

The device has yet to be placed on market in the EU or even advertised, this is due to the business element of the company I am at. Additonally, I have procedures for all the transnational provisions in Article 120. Due to no devices being placed on market or advertised none of those processes have been utilized. Given this information would you expect to the company to have a PMCF plan drawn up or just procedures on how to create a PMCF plan? The same question can apply to the other processes in the Article 120 transitional provisions.

Thank you for any insight provided.

In order for the EU MDR Article 120 legacy device MDD certificate to remain valid, all of the applicable conditions upon which issuance of that MDD certificate was based shall be maintained regardless of whether devices have yet been placed on the market.  For example regarding the context of your particular question, Annex III requires a PMCF Plan (where not eligible for the EU MDR's general waiver opportunity) as a condition for maintenance of the validity of the legacy MDD certificate.  In other words, said PMCF Plan (and overarching PMS Plan) is generally required to be drawn up and ready for execution as a condition of maintaining the validity of the legacy MDD certificate.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 27-Feb-2023 17:27
From: Anonymous Member
Subject: EU MDR PMCF and Legacy Devices

This message was posted by a user wishing to remain anonymous

All,

I have a "legacy device," class IIb, as defined in MDCG 2021-25. 

The device has yet to be placed on market in the EU or even advertised, this is due to the business element of the company I am at. Additonally, I have procedures for all the transnational provisions in Article 120. Due to no devices being placed on market or advertised none of those processes have been utilized. Given this information would you expect to the company to have a PMCF plan drawn up or just procedures on how to create a PMCF plan? The same question can apply to the other processes in the Article 120 transitional provisions.

Thank you for any insight provided.

Forgot to mention.  It is my understanding that, as a general rule, the planned/required PSUR shall also be drawn up at the required time.  If, at such time, no devices were yet placed on the market, then the PSUR simply states in the corresponding sections that there are yet no PMS / PMCF data collected for the marketing of the subject device because no subject devices have yet been placed on the market.

However, be aware that part of the PMS plan upon which the legacy MDD certificate is contingent requires collection and analysis of PMS data not just on the marketing of the subject device.  Specifically, the PMS plan also requires collection and analysis of data from specialist or technical literature, databases and/or registers, and publicly available information about similar medical devices.  Be sure you have suitably addressed those required PMS aspects even if you haven't yet marketed the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 28-Feb-2023 15:30
From: Kevin Randall
Subject: EU MDR PMCF and Legacy Devices

In order for the EU MDR Article 120 legacy device MDD certificate to remain valid, all of the applicable conditions upon which issuance of that MDD certificate was based shall be maintained regardless of whether devices have yet been placed on the market.  For example regarding the context of your particular question, Annex III requires a PMCF Plan (where not eligible for the EU MDR's general waiver opportunity) as a condition for maintenance of the validity of the legacy MDD certificate.  In other words, said PMCF Plan (and overarching PMS Plan) is generally required to be drawn up and ready for execution as a condition of maintaining the validity of the legacy MDD certificate.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 27-Feb-2023 17:27
From: Anonymous Member
Subject: EU MDR PMCF and Legacy Devices

This message was posted by a user wishing to remain anonymous

All,

I have a "legacy device," class IIb, as defined in MDCG 2021-25. 

The device has yet to be placed on market in the EU or even advertised, this is due to the business element of the company I am at. Additonally, I have procedures for all the transnational provisions in Article 120. Due to no devices being placed on market or advertised none of those processes have been utilized. Given this information would you expect to the company to have a PMCF plan drawn up or just procedures on how to create a PMCF plan? The same question can apply to the other processes in the Article 120 transitional provisions.

Thank you for any insight provided.

Forgot to mention.  It is my understanding that, as a general rule, the planned/required PSUR shall also be drawn up at the required time.  If, at such time, no devices were yet placed on the market, then the PSUR simply states in the corresponding sections that there are yet no PMS / PMCF data collected for the marketing of the subject device because no subject devices have yet been placed on the market.

However, be aware that part of the PMS plan upon which the legacy MDD certificate is contingent requires collection and analysis of PMS data not just on the marketing of the subject device.  Specifically, the PMS plan also requires collection and analysis of data from specialist or technical literature, databases and/or registers, and publicly available information about similar medical devices.  Be sure you have suitably addressed those required PMS aspects even if you haven't yet marketed the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 28-Feb-2023 15:30
From: Kevin Randall
Subject: EU MDR PMCF and Legacy Devices

In order for the EU MDR Article 120 legacy device MDD certificate to remain valid, all of the applicable conditions upon which issuance of that MDD certificate was based shall be maintained regardless of whether devices have yet been placed on the market.  For example regarding the context of your particular question, Annex III requires a PMCF Plan (where not eligible for the EU MDR's general waiver opportunity) as a condition for maintenance of the validity of the legacy MDD certificate.  In other words, said PMCF Plan (and overarching PMS Plan) is generally required to be drawn up and ready for execution as a condition of maintaining the validity of the legacy MDD certificate.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 27-Feb-2023 17:27
From: Anonymous Member
Subject: EU MDR PMCF and Legacy Devices

This message was posted by a user wishing to remain anonymous

All,

I have a "legacy device," class IIb, as defined in MDCG 2021-25. 

The device has yet to be placed on market in the EU or even advertised, this is due to the business element of the company I am at. Additonally, I have procedures for all the transnational provisions in Article 120. Due to no devices being placed on market or advertised none of those processes have been utilized. Given this information would you expect to the company to have a PMCF plan drawn up or just procedures on how to create a PMCF plan? The same question can apply to the other processes in the Article 120 transitional provisions.

Thank you for any insight provided.

All,

I have a "legacy device," class IIb, as defined in MDCG 2021-25. 

The device has yet to be placed on market in the EU or even advertised, this is due to the business element of the company I am at. Additonally, I have procedures for all the transnational provisions in Article 120. Due to no devices being placed on market or advertised none of those processes have been utilized. Given this information would you expect to the company to have a PMCF plan drawn up or just procedures on how to create a PMCF plan? The same question can apply to the other processes in the Article 120 transitional provisions.

Thank you for any insight provided.