Regulatory Open Forum

Under the Article 120(3) transition the device must meet the MDD requirements. MDD Annex X requires clinical evaluation. MDD clinical evaluation could lead to MDD PMCF. See MEDDEV 2.7-1 Rev 4 and MEDDEV 2.12-2 Rev 2.

Use the MDD PMCF to update the MDR Article 86 PSUR.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

Hi Sam! (can we still call you Sam or should we call you Salvatore?)

Glad to help!  Many thanks for the positive feedback.  Indeed, proper interpretation of the EU MDR can be a real challenge.

Cartoon © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

The key intent of my EU MDR PMS relational diagram was to help bring acuity to the big picture so that we don't get disoriented while navigating the various twists and turns of EU MDR PMS, PMCF, and Clinical Evaluation.  Accordingly, the diagram also reveals the important functional bridges (i.e., risk management, vigilance, and corrective/preventive action) that link PMS and PMCF to the Clinical Evaluation process.  Yet the diagram isn't intended to explain all the inner detailed workings of PMS; indeed, a more focused workflow diagram is needed for that.

Toward that end, you are correct:  The EU MDR PMS Plans (specifying items such as, but not limited to, the organization's planned proactive and reactive PMS, the organization's PMS data monitoring and analysis, and the planned PMS Reports and/or PSURs) and the execution of those Plans are anchored within the PMS process shape.  But remember that the PMS Plan, PMS Reports, and PSURs leverage, and closely relate to, other parts of the QMS (such as risk management, vigilance, and corrective/preventive action).  These interrelationships can cause confusion about the official borders of the PMS process vs. the borders of such peripherals.  In fact, such peripherals are directly mentioned in the PMS Plan boilerplate of EU MDR Annex III.1.1, perhaps raising questions about whether the peripherals are part of PMS or separate from PMS.  As modeled in my PMS relational diagram, they are separate, yet critically related.  And though separate, the peripherals need to be adapted as necessary in order to assure they properly serve the particular needs of EU MDR PMS in addition to the needs for which the peripherals are already deployed.  That approach avoids unnecessary duplication of such peripheral elements, thereby keeping the PMS and QMS processes as nimble, and the overall QMS as centralized, as possible.

An important example of this are the segments of the PMS Plan pertaining to EU MDR Annex III.1.1(b) first to fifth indents (i.e., those specifying proactive and systematic data collection via appropriate methods and processes; those specifying indicators and threshold values for use in the continuous reassessment of the benefit-risk analysis and risk management; those specifying methods and tools to investigate and analyze complaints and market-related experience; and those specifying methods and protocols for managing certain events subject to trend reporting). This PMS data collection process should be woven into the organization's preexisting data collection infrastructure that is already (hopefully) established, for example pursuant to ISO 13485 clause 8.4 [and, for organizations operating in both the EU and the U.S., also pursuant to FDA 21 CFR 820.100(a)(1)].  In so doing, the EU MDR Annex III.1.1(a) PMS informational sources and elements to be analyzed simply become additional data sources/elements added to (or reiterated in) the organization's preexisting data analysis process rather than creating a new or secondary data analysis mechanism for EU MDR PMS.

The preexisting data analysis process with alert and action limits (i.e., with "suitable indicators and threshold values") established therein for the various data sources and elements (including but not limited to PMS data) should thus already contain a bridge to the corrective/preventive action mechanism (which should in turn already contain a corresponding link to the product recall / FSCA process).  Accordingly, such an arrangement intrinsically addresses the corresponding requirements in EU MDR Annex III.1.1(b) eighth and ninth indents, again showing how this strategy can integrate, streamline, and centralize the QMS rather than creating QMS redundancy and dispersion.

With such a strategy and tactics, the initiating PMS Plan simply becomes a corresponding standardized explanation/outline, including cross-references where appropriate to the various tailored parts of the QMS being leveraged, plus any supplemental specifics needed to assure customized surveillance for the subject device(s) and to address the remaining general requirements of EU MDR Annex III.1.1. This kind of integrative and seamless approach also caters well to the general obligations imposed by EU MDR Article 10(9) third paragraph indent (i) requiring the PMS system to be integrated into the organization's overall QMS.

In due course when it's time to prepare the EU MDR Article 85 PMS Report (for Class I devices) or Article 86 PSUR (for Class IIa, IIb, and III devices), then that exercise simply becomes one of compiling a summary(s) of the results and conclusions already periodically generated or initiated for the PMS data as part of the aforesaid routine ongoing data analysis process.  And Sam, I generally agree with your interpretation; specifically, that the PSUR for Class IIa, IIb and III devices is just a special type of PMS report.  But I would add that our use of the formal label "PMS Report" should strictly be in relation only to EU MDR Article 85 and Class I devices.

Finally, regarding links to post-market Eudamed submissions, Notified Body review, Competent Authority review, etc., remember that EU MDR Articles 86(2) and 92(1)(d) assert that Eudamed submission of PSURs is only required for class III devices or implantable devices.  In contrast, EU MDR Article 86(3) merely states that the PSURs for non-implantable class IIa and IIb devices must simply be made available for Notified Body review during conformity assessment and, upon request, to the Competent Authorities.  This indicates that Eudamed submission will not be required for non-implantable class IIa and IIb device PSURs.  And for class I devices, remember also that the EU MDR Article 85 PMS Reports are likewise subject to Competent Authority review upon request.  This comes by way of EU MDR Article 10(8) and the required integration of those Reports into the Technical Documentation per EU MDR Annex III.1.2.  Moreover, regarding EU MDR conformity assessment of class I non-sterile, non-measuring, and reusable devices, don't forget that, pursuant to EU MDR Article 52(7) second and third sentences, Notified Body involvement is required.  Therefore, by default, this makes class I non-sterile, class I non-measuring, and class I reusable device PMS Reports subject to Notified Body review in a way analogous to that required by EU MDR Article 86(3) for Class IIa and IIb devices.

Hope this helps.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

MEDDEV 2.12/2 rev2  section 6 briefly mentions the methods in the elements of the study. However is there any more guidance on this aspect?

Regards,

Rashmi

Hi Sam! (can we still call you Sam or should we call you Salvatore?)

Glad to help!  Many thanks for the positive feedback.  Indeed, proper interpretation of the EU MDR can be a real challenge.

Cartoon © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

The key intent of my EU MDR PMS relational diagram was to help bring acuity to the big picture so that we don't get disoriented while navigating the various twists and turns of EU MDR PMS, PMCF, and Clinical Evaluation.  Accordingly, the diagram also reveals the important functional bridges (i.e., risk management, vigilance, and corrective/preventive action) that link PMS and PMCF to the Clinical Evaluation process.  Yet the diagram isn't intended to explain all the inner detailed workings of PMS; indeed, a more focused workflow diagram is needed for that.

Toward that end, you are correct:  The EU MDR PMS Plans (specifying items such as, but not limited to, the organization's planned proactive and reactive PMS, the organization's PMS data monitoring and analysis, and the planned PMS Reports and/or PSURs) and the execution of those Plans are anchored within the PMS process shape.  But remember that the PMS Plan, PMS Reports, and PSURs leverage, and closely relate to, other parts of the QMS (such as risk management, vigilance, and corrective/preventive action).  These interrelationships can cause confusion about the official borders of the PMS process vs. the borders of such peripherals.  In fact, such peripherals are directly mentioned in the PMS Plan boilerplate of EU MDR Annex III.1.1, perhaps raising questions about whether the peripherals are part of PMS or separate from PMS.  As modeled in my PMS relational diagram, they are separate, yet critically related.  And though separate, the peripherals need to be adapted as necessary in order to assure they properly serve the particular needs of EU MDR PMS in addition to the needs for which the peripherals are already deployed.  That approach avoids unnecessary duplication of such peripheral elements, thereby keeping the PMS and QMS processes as nimble, and the overall QMS as centralized, as possible.

An important example of this are the segments of the PMS Plan pertaining to EU MDR Annex III.1.1(b) first to fifth indents (i.e., those specifying proactive and systematic data collection via appropriate methods and processes; those specifying indicators and threshold values for use in the continuous reassessment of the benefit-risk analysis and risk management; those specifying methods and tools to investigate and analyze complaints and market-related experience; and those specifying methods and protocols for managing certain events subject to trend reporting). This PMS data collection process should be woven into the organization's preexisting data collection infrastructure that is already (hopefully) established, for example pursuant to ISO 13485 clause 8.4 [and, for organizations operating in both the EU and the U.S., also pursuant to FDA 21 CFR 820.100(a)(1)].  In so doing, the EU MDR Annex III.1.1(a) PMS informational sources and elements to be analyzed simply become additional data sources/elements added to (or reiterated in) the organization's preexisting data analysis process rather than creating a new or secondary data analysis mechanism for EU MDR PMS.

The preexisting data analysis process with alert and action limits (i.e., with "suitable indicators and threshold values") established therein for the various data sources and elements (including but not limited to PMS data) should thus already contain a bridge to the corrective/preventive action mechanism (which should in turn already contain a corresponding link to the product recall / FSCA process).  Accordingly, such an arrangement intrinsically addresses the corresponding requirements in EU MDR Annex III.1.1(b) eighth and ninth indents, again showing how this strategy can integrate, streamline, and centralize the QMS rather than creating QMS redundancy and dispersion.

With such a strategy and tactics, the initiating PMS Plan simply becomes a corresponding standardized explanation/outline, including cross-references where appropriate to the various tailored parts of the QMS being leveraged, plus any supplemental specifics needed to assure customized surveillance for the subject device(s) and to address the remaining general requirements of EU MDR Annex III.1.1. This kind of integrative and seamless approach also caters well to the general obligations imposed by EU MDR Article 10(9) third paragraph indent (i) requiring the PMS system to be integrated into the organization's overall QMS.

In due course when it's time to prepare the EU MDR Article 85 PMS Report (for Class I devices) or Article 86 PSUR (for Class IIa, IIb, and III devices), then that exercise simply becomes one of compiling a summary(s) of the results and conclusions already periodically generated or initiated for the PMS data as part of the aforesaid routine ongoing data analysis process.  And Sam, I generally agree with your interpretation; specifically, that the PSUR for Class IIa, IIb and III devices is just a special type of PMS report.  But I would add that our use of the formal label "PMS Report" should strictly be in relation only to EU MDR Article 85 and Class I devices.

Finally, regarding links to post-market Eudamed submissions, Notified Body review, Competent Authority review, etc., remember that EU MDR Articles 86(2) and 92(1)(d) assert that Eudamed submission of PSURs is only required for class III devices or implantable devices.  In contrast, EU MDR Article 86(3) merely states that the PSURs for non-implantable class IIa and IIb devices must simply be made available for Notified Body review during conformity assessment and, upon request, to the Competent Authorities.  This indicates that Eudamed submission will not be required for non-implantable class IIa and IIb device PSURs.  And for class I devices, remember also that the EU MDR Article 85 PMS Reports are likewise subject to Competent Authority review upon request.  This comes by way of EU MDR Article 10(8) and the required integration of those Reports into the Technical Documentation per EU MDR Annex III.1.2.  Moreover, regarding EU MDR conformity assessment of class I non-sterile, non-measuring, and reusable devices, don't forget that, pursuant to EU MDR Article 52(7) second and third sentences, Notified Body involvement is required.  Therefore, by default, this makes class I non-sterile, class I non-measuring, and class I reusable device PMS Reports subject to Notified Body review in a way analogous to that required by EU MDR Article 86(3) for Class IIa and IIb devices.

Hope this helps.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

MEDDEV 2.12/2 rev2  section 6 briefly mentions the methods in the elements of the study. However is there any more guidance on this aspect?

Regards,

Rashmi

Hi Sam! (can we still call you Sam or should we call you Salvatore?)

Glad to help!  Many thanks for the positive feedback.  Indeed, proper interpretation of the EU MDR can be a real challenge.

Cartoon © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

The key intent of my EU MDR PMS relational diagram was to help bring acuity to the big picture so that we don't get disoriented while navigating the various twists and turns of EU MDR PMS, PMCF, and Clinical Evaluation.  Accordingly, the diagram also reveals the important functional bridges (i.e., risk management, vigilance, and corrective/preventive action) that link PMS and PMCF to the Clinical Evaluation process.  Yet the diagram isn't intended to explain all the inner detailed workings of PMS; indeed, a more focused workflow diagram is needed for that.

Toward that end, you are correct:  The EU MDR PMS Plans (specifying items such as, but not limited to, the organization's planned proactive and reactive PMS, the organization's PMS data monitoring and analysis, and the planned PMS Reports and/or PSURs) and the execution of those Plans are anchored within the PMS process shape.  But remember that the PMS Plan, PMS Reports, and PSURs leverage, and closely relate to, other parts of the QMS (such as risk management, vigilance, and corrective/preventive action).  These interrelationships can cause confusion about the official borders of the PMS process vs. the borders of such peripherals.  In fact, such peripherals are directly mentioned in the PMS Plan boilerplate of EU MDR Annex III.1.1, perhaps raising questions about whether the peripherals are part of PMS or separate from PMS.  As modeled in my PMS relational diagram, they are separate, yet critically related.  And though separate, the peripherals need to be adapted as necessary in order to assure they properly serve the particular needs of EU MDR PMS in addition to the needs for which the peripherals are already deployed.  That approach avoids unnecessary duplication of such peripheral elements, thereby keeping the PMS and QMS processes as nimble, and the overall QMS as centralized, as possible.

An important example of this are the segments of the PMS Plan pertaining to EU MDR Annex III.1.1(b) first to fifth indents (i.e., those specifying proactive and systematic data collection via appropriate methods and processes; those specifying indicators and threshold values for use in the continuous reassessment of the benefit-risk analysis and risk management; those specifying methods and tools to investigate and analyze complaints and market-related experience; and those specifying methods and protocols for managing certain events subject to trend reporting). This PMS data collection process should be woven into the organization's preexisting data collection infrastructure that is already (hopefully) established, for example pursuant to ISO 13485 clause 8.4 [and, for organizations operating in both the EU and the U.S., also pursuant to FDA 21 CFR 820.100(a)(1)].  In so doing, the EU MDR Annex III.1.1(a) PMS informational sources and elements to be analyzed simply become additional data sources/elements added to (or reiterated in) the organization's preexisting data analysis process rather than creating a new or secondary data analysis mechanism for EU MDR PMS.

The preexisting data analysis process with alert and action limits (i.e., with "suitable indicators and threshold values") established therein for the various data sources and elements (including but not limited to PMS data) should thus already contain a bridge to the corrective/preventive action mechanism (which should in turn already contain a corresponding link to the product recall / FSCA process).  Accordingly, such an arrangement intrinsically addresses the corresponding requirements in EU MDR Annex III.1.1(b) eighth and ninth indents, again showing how this strategy can integrate, streamline, and centralize the QMS rather than creating QMS redundancy and dispersion.

With such a strategy and tactics, the initiating PMS Plan simply becomes a corresponding standardized explanation/outline, including cross-references where appropriate to the various tailored parts of the QMS being leveraged, plus any supplemental specifics needed to assure customized surveillance for the subject device(s) and to address the remaining general requirements of EU MDR Annex III.1.1. This kind of integrative and seamless approach also caters well to the general obligations imposed by EU MDR Article 10(9) third paragraph indent (i) requiring the PMS system to be integrated into the organization's overall QMS.

In due course when it's time to prepare the EU MDR Article 85 PMS Report (for Class I devices) or Article 86 PSUR (for Class IIa, IIb, and III devices), then that exercise simply becomes one of compiling a summary(s) of the results and conclusions already periodically generated or initiated for the PMS data as part of the aforesaid routine ongoing data analysis process.  And Sam, I generally agree with your interpretation; specifically, that the PSUR for Class IIa, IIb and III devices is just a special type of PMS report.  But I would add that our use of the formal label "PMS Report" should strictly be in relation only to EU MDR Article 85 and Class I devices.

Finally, regarding links to post-market Eudamed submissions, Notified Body review, Competent Authority review, etc., remember that EU MDR Articles 86(2) and 92(1)(d) assert that Eudamed submission of PSURs is only required for class III devices or implantable devices.  In contrast, EU MDR Article 86(3) merely states that the PSURs for non-implantable class IIa and IIb devices must simply be made available for Notified Body review during conformity assessment and, upon request, to the Competent Authorities.  This indicates that Eudamed submission will not be required for non-implantable class IIa and IIb device PSURs.  And for class I devices, remember also that the EU MDR Article 85 PMS Reports are likewise subject to Competent Authority review upon request.  This comes by way of EU MDR Article 10(8) and the required integration of those Reports into the Technical Documentation per EU MDR Annex III.1.2.  Moreover, regarding EU MDR conformity assessment of class I non-sterile, non-measuring, and reusable devices, don't forget that, pursuant to EU MDR Article 52(7) second and third sentences, Notified Body involvement is required.  Therefore, by default, this makes class I non-sterile, class I non-measuring, and class I reusable device PMS Reports subject to Notified Body review in a way analogous to that required by EU MDR Article 86(3) for Class IIa and IIb devices.

Hope this helps.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

Hi Rashmi,

My apologies for losing track of your question.  When tackling PMCF under the EU MDR, I still recommend employing the principles embodied in MEDDEV 2.12/2 for the design and control or waiver [see EU MDR Annex III.1.1(b) final indent] of PMCF.  This is because the basic principles and intent for PMCF as embodied by MEDDEV 2.12/2 (see lines 177 - 189) are the same as those integrated into the EU MDR (see Annex XIV Part B sec. 5).  Therefore, whether for the MDD or the MDR, I recommend that PMCF studies can follow various methodologies such as, but not limited to:

• extended follow-up of patients that were previously enrolled in premarket investigations;
• a new clinical investigation (yet still for the CE-marked device and for the same intended use and indications within the scope of the conformity assessment supporting the CE marking);
• a review of data derived from a device registry; or
• a review of relevant retrospective data from patients previously exposed to the device.

In the PMCF plan (if PMCF is not waived by the PMS Plan), be sure to suitably address in one way or another (i.e., commensurate with risk and complexity of the device) the following:

• define how the data is analyzed and conclusion(s) drawn.
• study population
• inclusion/exclusion criteria
• rational and justification of the chosen study design including use of controls/ control groups
• the selection of sites and investigators
• study objectives and related study endpoints and statistical considerations;
• the number of subjects involved;
• the duration of patient follow-up;
• the data to be collected;
• the analysis plan (to be performed by someone with appropriate expertise) including any interim reporting where appropriate to ensure continuous risk management based on clinical data
• procedures/criteria for early study termination;
• ethical considerations;
• methods of quality control for study execution and data management to assure compliance with the clinical investigation or study plan.

Hi Rashmi,

My apologies for losing track of your question.  When tackling PMCF under the EU MDR, I still recommend employing the principles embodied in MEDDEV 2.12/2 for the design and control or waiver [see EU MDR Annex III.1.1(b) final indent] of PMCF.  This is because the basic principles and intent for PMCF as embodied by MEDDEV 2.12/2 (see lines 177 - 189) are the same as those integrated into the EU MDR (see Annex XIV Part B sec. 5).  Therefore, whether for the MDD or the MDR, I recommend that PMCF studies can follow various methodologies such as, but not limited to:

• extended follow-up of patients that were previously enrolled in premarket investigations;
• a new clinical investigation (yet still for the CE-marked device and for the same intended use and indications within the scope of the conformity assessment supporting the CE marking);
• a review of data derived from a device registry; or
• a review of relevant retrospective data from patients previously exposed to the device.

In the PMCF plan (if PMCF is not waived by the PMS Plan), be sure to suitably address in one way or another (i.e., commensurate with risk and complexity of the device) the following:

• define how the data is analyzed and conclusion(s) drawn.
• study population
• inclusion/exclusion criteria
• rational and justification of the chosen study design including use of controls/ control groups
• the selection of sites and investigators
• study objectives and related study endpoints and statistical considerations;
• the number of subjects involved;
• the duration of patient follow-up;
• the data to be collected;
• the analysis plan (to be performed by someone with appropriate expertise) including any interim reporting where appropriate to ensure continuous risk management based on clinical data
• procedures/criteria for early study termination;
• ethical considerations;
• methods of quality control for study execution and data management to assure compliance with the clinical investigation or study plan.

Great question Rashmi!  As you probably know, MEDDEV 2.12/2 (for the MDD, not the MDR) established a European historical framework and precedent for waiver of PMCF.  Indeed, I have successfully leveraged such waivers repeatedly with NBs under the MDD without objection.  Fast forwarding to the EU MDR era, you may remember my prior Forum explanations of how the EU MDR considers PMCF to be part of PMS.  With that background in mind, remember that the EU MDR's PMS plan requirements in Annex III.1.1(b) final indent require that the PMS plan contain a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

Accordingly, I would beware of PMS / PMCF systems, assertions, training, or other paradigms that universally demand PMCF for all cases. Such an approach is certain to unnecessarily escalate the cost, complexity, and burden of that aspect of a company's EU MDR transition.

Hi Rashmi,

My apologies for losing track of your question.  When tackling PMCF under the EU MDR, I still recommend employing the principles embodied in MEDDEV 2.12/2 for the design and control or waiver [see EU MDR Annex III.1.1(b) final indent] of PMCF.  This is because the basic principles and intent for PMCF as embodied by MEDDEV 2.12/2 (see lines 177 - 189) are the same as those integrated into the EU MDR (see Annex XIV Part B sec. 5).  Therefore, whether for the MDD or the MDR, I recommend that PMCF studies can follow various methodologies such as, but not limited to:

• extended follow-up of patients that were previously enrolled in premarket investigations;
• a new clinical investigation (yet still for the CE-marked device and for the same intended use and indications within the scope of the conformity assessment supporting the CE marking);
• a review of data derived from a device registry; or
• a review of relevant retrospective data from patients previously exposed to the device.

In the PMCF plan (if PMCF is not waived by the PMS Plan), be sure to suitably address in one way or another (i.e., commensurate with risk and complexity of the device) the following:

• define how the data is analyzed and conclusion(s) drawn.
• study population
• inclusion/exclusion criteria
• rational and justification of the chosen study design including use of controls/ control groups
• the selection of sites and investigators
• study objectives and related study endpoints and statistical considerations;
• the number of subjects involved;
• the duration of patient follow-up;
• the data to be collected;
• the analysis plan (to be performed by someone with appropriate expertise) including any interim reporting where appropriate to ensure continuous risk management based on clinical data
• procedures/criteria for early study termination;
• ethical considerations;
• methods of quality control for study execution and data management to assure compliance with the clinical investigation or study plan.

Hi Sam! (can we still call you Sam or should we call you Salvatore?)

Glad to help!  Many thanks for the positive feedback.  Indeed, proper interpretation of the EU MDR can be a real challenge.

Cartoon © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

The key intent of my EU MDR PMS relational diagram was to help bring acuity to the big picture so that we don't get disoriented while navigating the various twists and turns of EU MDR PMS, PMCF, and Clinical Evaluation.  Accordingly, the diagram also reveals the important functional bridges (i.e., risk management, vigilance, and corrective/preventive action) that link PMS and PMCF to the Clinical Evaluation process.  Yet the diagram isn't intended to explain all the inner detailed workings of PMS; indeed, a more focused workflow diagram is needed for that.

Toward that end, you are correct:  The EU MDR PMS Plans (specifying items such as, but not limited to, the organization's planned proactive and reactive PMS, the organization's PMS data monitoring and analysis, and the planned PMS Reports and/or PSURs) and the execution of those Plans are anchored within the PMS process shape.  But remember that the PMS Plan, PMS Reports, and PSURs leverage, and closely relate to, other parts of the QMS (such as risk management, vigilance, and corrective/preventive action).  These interrelationships can cause confusion about the official borders of the PMS process vs. the borders of such peripherals.  In fact, such peripherals are directly mentioned in the PMS Plan boilerplate of EU MDR Annex III.1.1, perhaps raising questions about whether the peripherals are part of PMS or separate from PMS.  As modeled in my PMS relational diagram, they are separate, yet critically related.  And though separate, the peripherals need to be adapted as necessary in order to assure they properly serve the particular needs of EU MDR PMS in addition to the needs for which the peripherals are already deployed.  That approach avoids unnecessary duplication of such peripheral elements, thereby keeping the PMS and QMS processes as nimble, and the overall QMS as centralized, as possible.

An important example of this are the segments of the PMS Plan pertaining to EU MDR Annex III.1.1(b) first to fifth indents (i.e., those specifying proactive and systematic data collection via appropriate methods and processes; those specifying indicators and threshold values for use in the continuous reassessment of the benefit-risk analysis and risk management; those specifying methods and tools to investigate and analyze complaints and market-related experience; and those specifying methods and protocols for managing certain events subject to trend reporting). This PMS data collection process should be woven into the organization's preexisting data collection infrastructure that is already (hopefully) established, for example pursuant to ISO 13485 clause 8.4 [and, for organizations operating in both the EU and the U.S., also pursuant to FDA 21 CFR 820.100(a)(1)].  In so doing, the EU MDR Annex III.1.1(a) PMS informational sources and elements to be analyzed simply become additional data sources/elements added to (or reiterated in) the organization's preexisting data analysis process rather than creating a new or secondary data analysis mechanism for EU MDR PMS.

The preexisting data analysis process with alert and action limits (i.e., with "suitable indicators and threshold values") established therein for the various data sources and elements (including but not limited to PMS data) should thus already contain a bridge to the corrective/preventive action mechanism (which should in turn already contain a corresponding link to the product recall / FSCA process).  Accordingly, such an arrangement intrinsically addresses the corresponding requirements in EU MDR Annex III.1.1(b) eighth and ninth indents, again showing how this strategy can integrate, streamline, and centralize the QMS rather than creating QMS redundancy and dispersion.

With such a strategy and tactics, the initiating PMS Plan simply becomes a corresponding standardized explanation/outline, including cross-references where appropriate to the various tailored parts of the QMS being leveraged, plus any supplemental specifics needed to assure customized surveillance for the subject device(s) and to address the remaining general requirements of EU MDR Annex III.1.1. This kind of integrative and seamless approach also caters well to the general obligations imposed by EU MDR Article 10(9) third paragraph indent (i) requiring the PMS system to be integrated into the organization's overall QMS.

In due course when it's time to prepare the EU MDR Article 85 PMS Report (for Class I devices) or Article 86 PSUR (for Class IIa, IIb, and III devices), then that exercise simply becomes one of compiling a summary(s) of the results and conclusions already periodically generated or initiated for the PMS data as part of the aforesaid routine ongoing data analysis process.  And Sam, I generally agree with your interpretation; specifically, that the PSUR for Class IIa, IIb and III devices is just a special type of PMS report.  But I would add that our use of the formal label "PMS Report" should strictly be in relation only to EU MDR Article 85 and Class I devices.

Finally, regarding links to post-market Eudamed submissions, Notified Body review, Competent Authority review, etc., remember that EU MDR Articles 86(2) and 92(1)(d) assert that Eudamed submission of PSURs is only required for class III devices or implantable devices.  In contrast, EU MDR Article 86(3) merely states that the PSURs for non-implantable class IIa and IIb devices must simply be made available for Notified Body review during conformity assessment and, upon request, to the Competent Authorities.  This indicates that Eudamed submission will not be required for non-implantable class IIa and IIb device PSURs.  And for class I devices, remember also that the EU MDR Article 85 PMS Reports are likewise subject to Competent Authority review upon request.  This comes by way of EU MDR Article 10(8) and the required integration of those Reports into the Technical Documentation per EU MDR Annex III.1.2.  Moreover, regarding EU MDR conformity assessment of class I non-sterile, non-measuring, and reusable devices, don't forget that, pursuant to EU MDR Article 52(7) second and third sentences, Notified Body involvement is required.  Therefore, by default, this makes class I non-sterile, class I non-measuring, and class I reusable device PMS Reports subject to Notified Body review in a way analogous to that required by EU MDR Article 86(3) for Class IIa and IIb devices.

Hope this helps.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

Hi Sam! (can we still call you Sam or should we call you Salvatore?)

Glad to help!  Many thanks for the positive feedback.  Indeed, proper interpretation of the EU MDR can be a real challenge.

Cartoon © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

The key intent of my EU MDR PMS relational diagram was to help bring acuity to the big picture so that we don't get disoriented while navigating the various twists and turns of EU MDR PMS, PMCF, and Clinical Evaluation.  Accordingly, the diagram also reveals the important functional bridges (i.e., risk management, vigilance, and corrective/preventive action) that link PMS and PMCF to the Clinical Evaluation process.  Yet the diagram isn't intended to explain all the inner detailed workings of PMS; indeed, a more focused workflow diagram is needed for that.

Toward that end, you are correct:  The EU MDR PMS Plans (specifying items such as, but not limited to, the organization's planned proactive and reactive PMS, the organization's PMS data monitoring and analysis, and the planned PMS Reports and/or PSURs) and the execution of those Plans are anchored within the PMS process shape.  But remember that the PMS Plan, PMS Reports, and PSURs leverage, and closely relate to, other parts of the QMS (such as risk management, vigilance, and corrective/preventive action).  These interrelationships can cause confusion about the official borders of the PMS process vs. the borders of such peripherals.  In fact, such peripherals are directly mentioned in the PMS Plan boilerplate of EU MDR Annex III.1.1, perhaps raising questions about whether the peripherals are part of PMS or separate from PMS.  As modeled in my PMS relational diagram, they are separate, yet critically related.  And though separate, the peripherals need to be adapted as necessary in order to assure they properly serve the particular needs of EU MDR PMS in addition to the needs for which the peripherals are already deployed.  That approach avoids unnecessary duplication of such peripheral elements, thereby keeping the PMS and QMS processes as nimble, and the overall QMS as centralized, as possible.

An important example of this are the segments of the PMS Plan pertaining to EU MDR Annex III.1.1(b) first to fifth indents (i.e., those specifying proactive and systematic data collection via appropriate methods and processes; those specifying indicators and threshold values for use in the continuous reassessment of the benefit-risk analysis and risk management; those specifying methods and tools to investigate and analyze complaints and market-related experience; and those specifying methods and protocols for managing certain events subject to trend reporting). This PMS data collection process should be woven into the organization's preexisting data collection infrastructure that is already (hopefully) established, for example pursuant to ISO 13485 clause 8.4 [and, for organizations operating in both the EU and the U.S., also pursuant to FDA 21 CFR 820.100(a)(1)].  In so doing, the EU MDR Annex III.1.1(a) PMS informational sources and elements to be analyzed simply become additional data sources/elements added to (or reiterated in) the organization's preexisting data analysis process rather than creating a new or secondary data analysis mechanism for EU MDR PMS.

The preexisting data analysis process with alert and action limits (i.e., with "suitable indicators and threshold values") established therein for the various data sources and elements (including but not limited to PMS data) should thus already contain a bridge to the corrective/preventive action mechanism (which should in turn already contain a corresponding link to the product recall / FSCA process).  Accordingly, such an arrangement intrinsically addresses the corresponding requirements in EU MDR Annex III.1.1(b) eighth and ninth indents, again showing how this strategy can integrate, streamline, and centralize the QMS rather than creating QMS redundancy and dispersion.

With such a strategy and tactics, the initiating PMS Plan simply becomes a corresponding standardized explanation/outline, including cross-references where appropriate to the various tailored parts of the QMS being leveraged, plus any supplemental specifics needed to assure customized surveillance for the subject device(s) and to address the remaining general requirements of EU MDR Annex III.1.1. This kind of integrative and seamless approach also caters well to the general obligations imposed by EU MDR Article 10(9) third paragraph indent (i) requiring the PMS system to be integrated into the organization's overall QMS.

In due course when it's time to prepare the EU MDR Article 85 PMS Report (for Class I devices) or Article 86 PSUR (for Class IIa, IIb, and III devices), then that exercise simply becomes one of compiling a summary(s) of the results and conclusions already periodically generated or initiated for the PMS data as part of the aforesaid routine ongoing data analysis process.  And Sam, I generally agree with your interpretation; specifically, that the PSUR for Class IIa, IIb and III devices is just a special type of PMS report.  But I would add that our use of the formal label "PMS Report" should strictly be in relation only to EU MDR Article 85 and Class I devices.

Finally, regarding links to post-market Eudamed submissions, Notified Body review, Competent Authority review, etc., remember that EU MDR Articles 86(2) and 92(1)(d) assert that Eudamed submission of PSURs is only required for class III devices or implantable devices.  In contrast, EU MDR Article 86(3) merely states that the PSURs for non-implantable class IIa and IIb devices must simply be made available for Notified Body review during conformity assessment and, upon request, to the Competent Authorities.  This indicates that Eudamed submission will not be required for non-implantable class IIa and IIb device PSURs.  And for class I devices, remember also that the EU MDR Article 85 PMS Reports are likewise subject to Competent Authority review upon request.  This comes by way of EU MDR Article 10(8) and the required integration of those Reports into the Technical Documentation per EU MDR Annex III.1.2.  Moreover, regarding EU MDR conformity assessment of class I non-sterile, non-measuring, and reusable devices, don't forget that, pursuant to EU MDR Article 52(7) second and third sentences, Notified Body involvement is required.  Therefore, by default, this makes class I non-sterile, class I non-measuring, and class I reusable device PMS Reports subject to Notified Body review in a way analogous to that required by EU MDR Article 86(3) for Class IIa and IIb devices.

Hope this helps.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,

Hi Sam! (can we still call you Sam or should we call you Salvatore?)

Glad to help!  Many thanks for the positive feedback.  Indeed, proper interpretation of the EU MDR can be a real challenge.

Cartoon © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.

The key intent of my EU MDR PMS relational diagram was to help bring acuity to the big picture so that we don't get disoriented while navigating the various twists and turns of EU MDR PMS, PMCF, and Clinical Evaluation.  Accordingly, the diagram also reveals the important functional bridges (i.e., risk management, vigilance, and corrective/preventive action) that link PMS and PMCF to the Clinical Evaluation process.  Yet the diagram isn't intended to explain all the inner detailed workings of PMS; indeed, a more focused workflow diagram is needed for that.

Toward that end, you are correct:  The EU MDR PMS Plans (specifying items such as, but not limited to, the organization's planned proactive and reactive PMS, the organization's PMS data monitoring and analysis, and the planned PMS Reports and/or PSURs) and the execution of those Plans are anchored within the PMS process shape.  But remember that the PMS Plan, PMS Reports, and PSURs leverage, and closely relate to, other parts of the QMS (such as risk management, vigilance, and corrective/preventive action).  These interrelationships can cause confusion about the official borders of the PMS process vs. the borders of such peripherals.  In fact, such peripherals are directly mentioned in the PMS Plan boilerplate of EU MDR Annex III.1.1, perhaps raising questions about whether the peripherals are part of PMS or separate from PMS.  As modeled in my PMS relational diagram, they are separate, yet critically related.  And though separate, the peripherals need to be adapted as necessary in order to assure they properly serve the particular needs of EU MDR PMS in addition to the needs for which the peripherals are already deployed.  That approach avoids unnecessary duplication of such peripheral elements, thereby keeping the PMS and QMS processes as nimble, and the overall QMS as centralized, as possible.

An important example of this are the segments of the PMS Plan pertaining to EU MDR Annex III.1.1(b) first to fifth indents (i.e., those specifying proactive and systematic data collection via appropriate methods and processes; those specifying indicators and threshold values for use in the continuous reassessment of the benefit-risk analysis and risk management; those specifying methods and tools to investigate and analyze complaints and market-related experience; and those specifying methods and protocols for managing certain events subject to trend reporting). This PMS data collection process should be woven into the organization's preexisting data collection infrastructure that is already (hopefully) established, for example pursuant to ISO 13485 clause 8.4 [and, for organizations operating in both the EU and the U.S., also pursuant to FDA 21 CFR 820.100(a)(1)].  In so doing, the EU MDR Annex III.1.1(a) PMS informational sources and elements to be analyzed simply become additional data sources/elements added to (or reiterated in) the organization's preexisting data analysis process rather than creating a new or secondary data analysis mechanism for EU MDR PMS.

The preexisting data analysis process with alert and action limits (i.e., with "suitable indicators and threshold values") established therein for the various data sources and elements (including but not limited to PMS data) should thus already contain a bridge to the corrective/preventive action mechanism (which should in turn already contain a corresponding link to the product recall / FSCA process).  Accordingly, such an arrangement intrinsically addresses the corresponding requirements in EU MDR Annex III.1.1(b) eighth and ninth indents, again showing how this strategy can integrate, streamline, and centralize the QMS rather than creating QMS redundancy and dispersion.

With such a strategy and tactics, the initiating PMS Plan simply becomes a corresponding standardized explanation/outline, including cross-references where appropriate to the various tailored parts of the QMS being leveraged, plus any supplemental specifics needed to assure customized surveillance for the subject device(s) and to address the remaining general requirements of EU MDR Annex III.1.1. This kind of integrative and seamless approach also caters well to the general obligations imposed by EU MDR Article 10(9) third paragraph indent (i) requiring the PMS system to be integrated into the organization's overall QMS.

In due course when it's time to prepare the EU MDR Article 85 PMS Report (for Class I devices) or Article 86 PSUR (for Class IIa, IIb, and III devices), then that exercise simply becomes one of compiling a summary(s) of the results and conclusions already periodically generated or initiated for the PMS data as part of the aforesaid routine ongoing data analysis process.  And Sam, I generally agree with your interpretation; specifically, that the PSUR for Class IIa, IIb and III devices is just a special type of PMS report.  But I would add that our use of the formal label "PMS Report" should strictly be in relation only to EU MDR Article 85 and Class I devices.

Finally, regarding links to post-market Eudamed submissions, Notified Body review, Competent Authority review, etc., remember that EU MDR Articles 86(2) and 92(1)(d) assert that Eudamed submission of PSURs is only required for class III devices or implantable devices.  In contrast, EU MDR Article 86(3) merely states that the PSURs for non-implantable class IIa and IIb devices must simply be made available for Notified Body review during conformity assessment and, upon request, to the Competent Authorities.  This indicates that Eudamed submission will not be required for non-implantable class IIa and IIb device PSURs.  And for class I devices, remember also that the EU MDR Article 85 PMS Reports are likewise subject to Competent Authority review upon request.  This comes by way of EU MDR Article 10(8) and the required integration of those Reports into the Technical Documentation per EU MDR Annex III.1.2.  Moreover, regarding EU MDR conformity assessment of class I non-sterile, non-measuring, and reusable devices, don't forget that, pursuant to EU MDR Article 52(7) second and third sentences, Notified Body involvement is required.  Therefore, by default, this makes class I non-sterile, class I non-measuring, and class I reusable device PMS Reports subject to Notified Body review in a way analogous to that required by EU MDR Article 86(3) for Class IIa and IIb devices.

Hope this helps.

Despite the close proximity and togetherness of clinical evaluation and PMCF in Annex XIV as well as at various places in the MDR [like Articles 10.3,10.9, 61.11, 106.10(b) and Annex VII.4.5.5], remember that, per Annex XIV.B.8 and Article 61.11 [and per traditional practice such as MEDDEV 2.7/1 Rev. 4 Section 10.2(d) and 2.12/2 Rev. 2 Sections 1, 5 & 7], PMCF is related to the clinical evaluation only in so far as to give consideration to the PMCF data (if any) during the clinical evaluation, and then only for the purpose of deciding on the basic need (or lack thereof) for PMCF (or additional PMCF).

In contrast, the actual detailed planning and execution of PMCF is considered to be part of PMS and is therefore done as part of the Chapter VII / Annex III PMS Plan [see Annex III.1.1(b) final indent as well as Annex XIV.B.5] and corresponding execution.

So apart from a clinical evaluation's declaration of the basic need (or lack thereof) for PMCF, it shouldn't be considered part of the clinical evaluation.  See ComplianceAcuity's attached workflow diagram showing the EU Regulation 2017/745 interrelationships between PMS, PMCF and Clinical Evaluation.

Hope this helps,