eu mdr post-market surveillance - fdanews

EU MDR Post-Market Surveillance

Best Practices for Medical Device Regulatory,

Compliance & Quality Specialists

Jon Gimbel, Ph.D. –Executive Director – Regulatory & Quality Solutions (R&Q)

CONFIDENTIAL © 2020 R&Q RQTeam.com 2

Agenda

▪ PMS Requirements

▪ PMS Planning

▪ PMS Reporting

▪ Now What?

▪ Q&A

2


Post-Market Surveil lance – Definition

▪ MDR Article 2 Section 60:▪ ‘post-market surveillance’ means all activities carried out by

manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactivelycollect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions


Post-Market Surveil lance – Requirements

▪ MDR Article 83:▪ For each device, manufacturers shall plan, establish, document, implement,

maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device

▪ The post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions


PMCF – Requirements

▪ MDR ANNEX XIV Part B▪ PMCF shall be understood to be a continuous process that updates the

clinical evaluation…and shall be addressed in the manufacturer's post-market surveillance plan.

▪ When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking…with the aim of ▪ confirming the safety and performance throughout the expected lifetime of the

device

▪ ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence


Post-Market Surveil lance – Article 83(3)

▪ The goal of the PMS system is to:▪ Update risk management, labeling, and clinical evaluation

▪ Identify need for corrective, preventative, or field safety corrective actions

▪ Improve the usability, performance, and safety of the device

▪ Contribute to the PMS of other devices

▪ Detect and report trends which may impact the benefit-risk analysis, health or safety


Post-Market Clinical Follow-Up – Annex XIV

▪ The goal of PMCF is to proactively collect and evaluate clinical data from use of device with aim of:

▪ Confirming safety & performance throughout device’s expected lifetime

▪ Identifying previously unknown / monitoring known side effects

▪ Identifying and analyzing emergent risks

▪ Ensuring continued acceptability of benefit-risk ratio

▪ Identifying possible system misuse or off-label use of device


Documentation requirements

PMS Plan

PMCF Plan

Cla

ss I

All

Cla

sses

Cla

ss II

a/b

&

III

PSURUpdated annually (Class IIb & III)Updated every 2 years (Class IIa)

Submitted to NB via electronic system (Class III)Made available to NB and by request to CA (all other classes)

CERUpdated based on PMS and PMCF as needed

Updated at least annually if the device carries significant risk or is not yet well established

Updated very 2 – 5 years otherwise

PMS ReportUpdated when necessary

Available to CA on request

SSCPPublicly Available Published by NB

on EUDAMED

Cla

ss II

I &

Imp

lan

tab

lesCEP

ClinicalDevelopmentPlan

PMCF Evaluation ReportUpdated when necessary

Updated annually (Class III & Implantables)

PMCF Plan

Technical Documentation

Clinical

Technical

PMSPMCF

Lege

nd


Report frequencies

Class I Class IIa Class IIb Class III

CERClinical Evaluation Report

After receiving PMS information with potential to change current evaluationAt least annually if the device carries significant risk or is not yet well established

Every 2 – 5 years if device is not expected to carry significant risks and is well establishedRef: MEDDEV 2.7/1 Rev 4 Clause 6.2.3

PMS ReportPost Market Surveillance

When necessaryRef: MDR Art. 85

N/A N/A N/A

PSURPeriodic Safety Update Report

N/A When necessary and at least every 2 years Ref:

MDR Art. 86(1)

At least annuallyRef: MDR Art. 86(1)

PMCF Evaluation ReportPost-Market Clinical Follow-up

When needed and according to the PMCF Plan(Ref. MDR Annex XIV Part B)

If implantable, at least annuallyRef MDR Art. 61(11)

Otherwise, when needed and according to PMCF plan(Ref. MDR Annex XIV Part B)


SS&CPSummary of Safety & Clinical Performance

N/A N/A unless device is implantableIf implantable, at least annually

Ref: MDR Art. 61(11)



Typical PMS / PMCF activities

Pro-Active PMS / PMCF, e.g.,- PMCF studies- Registry studies- Retrospective Record Review - Focus groups- Surveys

Reactive PMS, e.g.,- Complaints- FSCAs / Recalls- Incident reports / MDRs

Literature / Database Reviews


Typical PMS / PMCF activities

Pro-Active PMS / PMCF, e.g.,- PMCF studies- Registry studies- Retrospective Record Review - Focus groups- Surveys

Reactive PMS, e.g.,- Complaints- FSCAs / Recalls- Incident reports / MDRs

Literature / Database Reviews

Annex XIV PMCF: General methods…such as…screening of scientific literature;…

Annex III: The PMS plan shall address the collection [of]…technical literature, databases and/or registers


PMCF – MEDDEV 2.12/2 PMCF studies

▪ A precondition for placing a product on the market is that conformity to the relevant Essential Requirements has been demonstrated

▪ Limitations to pre-market clinical data▪ duration of pre-market clinical investigations▪ number of subjects and investigators involved▪ heterogeneity of subjects and investigators versus general medical practice▪ ability to detect rare complications after wide-spread or long term use

▪ Clinical data obtained from PMS and PMCF studies are▪ not intended to replace the pre-market data necessary to demonstrate

conformity▪ critical to updating the clinical evaluation and ensuring long term safety

and performance of devices placed on the market



▪ Circumstances that may justify PMCF studies include, for example▪ Innovative, novel device▪ Significant changes▪ High product related risk; High risk anatomical locations; High risk target populations;

Severity of disease/treatment challenges▪ Questions of ability to generalize clinical investigation results; Verification of safety and

performance of device when exposed to a larger and more varied population of clinical users

▪ Unanswered questions of long-term safety and performance; Continued validation of the expected life of the product; Emergence of new information on safety or performance; Results from any previous clinical investigation or PMS activities; Risks identified from the literature or other data sources for similar marketed devices

▪ Identification of unstudied subpopulations; Interaction with other medical products or treatments

▪ Where CE marking was based on equivalence.



▪ PMCF studies may not be required when ▪ The medium/long-term safety and clinical performance are already known

from previous use of the device

▪ Other appropriate PMS activities would provide sufficient data to address the risks

▪ PMCF study plans should include include:▪ clearly stated research questions, objectives and related endpoints

▪ scientifically sound design with an appropriate rationale and statistical analysis plan

▪ a plan for conduct according to the appropriate standards

▪ a plan for an analysis of the data and for drawing appropriate conclusions



▪ NB shall▪ verify that the manufacturer has appropriately considered the need

for PMCF based on the clinical evaluation and the characteristics of the medical device

▪ verify that PMCF is conducted when clinical evaluation was based exclusively on clinical data from equivalent devices

▪ assess the appropriateness of any justification presented by a manufacturer for not conducting a specific PMCF plan

▪ assess the appropriateness of the proposed PMCF plan

▪ verify that the clinical evaluation is being actively updated with PMCF data


Notes on Justifying Not Performing PMCF

▪ Unlikely to work on high risk devices

▪ Exception, not the rule▪ Where device is being discontinued

(monitoring end of lifetime of device) ▪ Common Specifications exist and exempt

PMCFs▪ Performance standards exist for the

device and good data exists on real life use for the lifetime of the device

▪ Lower risk devices (Class I)

▪ Need sufficient clinical data

▪ Tip: May be better to use low-level proactive activities (like literature searches) rather than attempt to justify

MDR Article 86: Class IIa, IIb, IIIPSUR requires main findings of the PMCF

MDR Article 61(4): Class III and implantable Clinical investigations shall be performed, except if…modified device…and clinical evaluation of marketed device is sufficient…In this case the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.

MDR Definitions: PMSActivities carried out…to proactively collect and review experience gained from devices…


Notes on Sufficient Data and PMCF Activities Needed

▪ Need sufficient data in the clinical evaluation▪ Manufacturer justifies the level of clinical evidence necessary

▪ Level of clinical evidence depends on device intended purpose

▪ Should establish specific and measurable outcome parameters

▪ PMCF needs to collect relevant data, e.g.,▪ Registries outcome parameters should align with manufacturers

parameters of interest

▪ Literature searches need to provide relevant articles

▪ Should justify type and sample size of the PMCF activity






▪ PMCF needs to collect relevant data, e.g.,▪ Registries outcome parameters should align with manufacturers




Article 2: Clinical Benefitpositive impact of a device…expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s)…

Annex XIV: Clinical Evaluation Plan…shall include…a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;

MDCG 2019-9: SSCPGive a description of the documented clinical benefits for patients with relevant and specified clinical outcome measures, and the success rate for achieving the outcome measures.






▪ PMCF needs to collect relevant data▪ Registries outcome parameters should align with manufacturers





Key dates, requirements, and l imitations

EU MDR DOA 26-May 2020

UDI Data in EUDAMED

Last MDD Certificate Valid26-May-2024

UDI on Class I Labels26-May-2025

UDI on Class II Labels26-May-2023

UDI on Class III Labels26-May-2021

New Date of Applicability

Notified Bodies start to be designated for MDR certification

2018 2019 2021 2022 2023

Class I Devices (except IS/IM)

Class IR Devices

All Other devices

QMS

2020 2024 2025

MDR Only - Requires MDR Compliant QMS

MDR Only

Existing devices with valid MDD Cert(s)

(No significant design changes)Sell Thru

No New devices until QMS is compliant MDR Only

Or Class Ir

EUDAMED Delay

Registration in EUDAMED11/2023


May 26, 2020 (2021) Checklist

▪ Execute all pending design changes through change management

▪ Issue DoC before May 26th for all MDD transition devices

▪ Update Vigilance, PMS, PMCF Procedures

▪ Confirm agreements with your Economic Operators include MDR requirements (e.g. complaints, registration in EUDAMED, communications)

▪ Implement Trending of Complaint Data (severity and frequency)

▪ Create PMS/PMCF plans; schedule reports

▪ Finish application process for MDR NB support and sign contract


Agenda


▪ PMS Planning

▪ PMS Reporting

▪ Now What?

▪ Q&A

22

CONFIDENTIAL, © 2017 R&Q

WHAT DOCUMENTS ARE REQUIRED?• Requirements requiring clinical data support• Intended purpose & target population• Clinical benefits with clinical outcome parameters• Methods for examining clinical safety• Parameters for benefit-risk acceptability and

intended purpose• Clinical Development Plan

• Planned progression of investigations• Exploratory (e.g., first-in-man,

feasibility, pilot studies)• Confirmatory (e.g. pivotal

investigations)• Post Market Clinical Follow-Up (PMCF) Plan• Milestones• Potential acceptance criteria

Clinical Evaluation

Plan

Clinical Development

Plan

Post Market Surveillance

Plan

Post Market Clinical

Follow-Up Plan

Ris

k M

anag

em

en

t


WHAT DOCUMENTS ARE REQUIRED

• General methods (ex. gathering of clinical experience gained, feedback from users, screening of scientific literature)

• Specific methods (ex. evaluation of suitable registers, PMCF studies)

• Reference to relevant parts of CER and Risk Management• Specific objectives to be addressed• Detailed & justified time schedule for PMCF activities

• Proactive & systematic process to collect any information• Methods & processes to assess collected data• Indicators/threshold values to be used for reassessment

of benefit-risk analysis and risk management• Methods to communicate with competent authorities,

notified bodies, economic operators and users• Methods & tools to investigate complaints/experience

collected in the field• Effective tools to trace & identify devices which may need

corrective actions• A PMCF plan or justification of why it is not applicable

Clinical Evaluation

Plan

Clinical Development

Plan

Post Market Surveillance

Plan

Post Market Clinical

Follow-Up Plan

Ris

k M

anag

em

en

t


Example Process Flow

CEP LSPs LSRs

PMS Plan

PMCF Plan

PMS Report

PMCF Report

CER

Risk Management Documentation /Technical Documentation

PMS Data

PMCF Data

SSCP

SME Review,Update,

&Finalize



CEP LSPs

PMS Plan

PMCF Plan

PMS Report

PMCF Report


PMS Data

PMCF Data

SSCP

SME Review,Update,

&Finalize

CER


Agenda


▪ PMS Planning

▪ PMS Reporting

▪ Now What?

▪ Q&A

27


REPORT REQUIREMENTS

CER

SS&CP(Class III &

implantables)

PMCF Eval.

ReportPMS Report (Class I)

PSUR (Class IIa,

IIb, and III)

• Results of clinical evaluation including• Scientific literature• Clinical investigations

• Qualifications of evaluator• Alternative treatment options• Demonstrated device equivalence if applicable• PMCF Evaluation Report

Technical Documentation• Manufacturer + SRN• Device + UDI-DI• Intended purpose, indications, contra-indications, and

target population• Descriptions, previous variant(s), differences, accessories,

other products intended to be used in combination• Possible diagnostic or therapeutic alternatives• Harmonized Standards / Common Specifications• Summary of the CER + PMCF• Suggested profile and training for users• Information on residual risk, undesirable effects, warnings

& precautions


REPORT REQUIREMENTS

CER

SS&CP(Class III &

implantables)

PMCF Eval.

ReportPMS Report (Class I)

PSUR (Class IIa,

IIb, and III)

Technical Documentation

• Summary of analysis of PMS data• Corrective & preventative action description• Conclusions of the benefit-risk determination• Main findings of the PMCF• Information on amount of device usage

• Summary of analysis of PMS data• Corrective & preventative action description

• PMCF analysis results• Corrective & preventative actions identified

through PMCF



CEP LSPs LSRs

PMS Plan

PMCF Plan

PMS Report

PMCF Report

CER


PMS Data

PMCF Data

SSCP

SME Review,Update,

&Finalize

Clinical

Technical

PMSPMCF

Lege

nd


Art. 85 and 86 post-market surveil lance reports – elements

▪ PMS report▪ Results of the PMS plan

▪ Description of preventative and corrective actions taken

▪ PSUR▪ Results of the PMS plan

▪ Description of preventative and corrective action

▪ Benefit-risk determination

▪ PMCF findings

▪ Sales volume

▪ Size and characteristics of the user population

▪ Usage frequency


Art. 85 and 86 post-market surveil lance reports – elements

▪ PMS report▪ Results of the PMS plan

▪ Complaints and trends

▪ Incidents

▪ FSCAs

▪ Literature

▪ Databases

▪ Registries

▪ Info on similar devices

▪ PMCF, if applicable

▪ Description of preventative and corrective actions taken

▪ PSUR▪ Results of the PMS plan

▪ Description of preventative and corrective action

▪ Benefit-risk determination

▪ PMCF findings

▪ Sales volume

▪ Size and characteristics of the user population

▪ Usage frequency


Art. 85 and 86 PMS reports –data packets

▪ PSUR▪ Sales volume / usage

▪ Complaints

▪ Incident reports, MDRs

▪ FSCA, recalls

▪ CAPA

▪ Database reviews

▪ Registry reviews

▪ Literature reviews

▪ PMCF findings

Clinical

Technical

PMSPMCF

Lege

nd

Misuse / Off-Label Use Data

Literature review for device

Literature review for similar

devices

Sales / Usage Data

CAPA data

Recalls / FSCA

Incident reports, MDRs

Database review for similar

devices

Complaint data

Database review for device


PMCF findings


ANNEX XIV(B) PMCF – data packets

▪ PMCF report:▪ Proactive feedback

▪ Literature review

▪ Registry review

▪ PMCF studies, registries

▪ Data for similar devices

▪ Standards, CSs, guidance docs

Standards and CSs


Proactive feedback, e.g.,

surveys

PMCF studies



devices

Registry review for device

Registry review for similar

devices



Clinical

Technical

PMSPMCF

Lege

nd


Data for CER

Standards and CSs



surveys

PMCF studies, Registries



devices

Sales / Usage Data

CAPA dataRecalls / FSCA



devices

Complaint data




devices



LSRs

PMS Report

PMCF Report

CER

Clinical

Technical

PMSPMCF

Lege

nd


Data for CER

Standards and CSs



surveys

PMCF studies, Registries



devices

Sales / Usage Data

CAPA dataRecalls / FSCA



devices

Complaint data




devices



LSRs

PMS Report

PMCF Report

CER

- Provides summary and evaluation of all clinical data to demonstrates conformity to GSPRs 1 and 8

- Includes conclusions regarding alignment between the clinical data, risk management and labeling

- Determines need for PMS / PMCF

Clinical

Technical

PMSPMCF

Lege

nd



CEP LSPs LSRs

PMS Plan

PMCF Plan

PSUR

PMCF Report

CER


PMS Data

PMCF Data

SSCP

SME Review,Update,

&Finalize

Clinical

Technical

PMSPMCF

Lege

nd


Process Flow

SME Review

Final Review

&Sign

PMS Plan / Report

PMCF Plan / Report

UpdateRisk Docs

IFU

CER,SSCP

- Includes experts from quality, risk management, regulatory, engineering / product development, clinical, etc…

- Confirms conclusions and determines action items

- Benefits- Facilitates integration of

different areas- Provides documentation

of decisions- Enables experts to align

on actions- Allows actions to be

integrated into CER


Notes on Risk Management, Complaints, and Clinical Data Alignment

▪ Risk management vs clinical studies and literature articles▪ Risk occurrence definitions do not typically match adverse event rates in

clinical studies▪ Harms are not always clearly listed in risk management file

▪ Risk management vs complaints▪ Complaint coding and adverse event reports are typically not categorized to

make it easy to compare to the hazard analysis

▪ At a minimum, ▪ Need to determine whether risks identified are covered in the risk

management file and residual risks are covered in the IFU▪ Compatibility matrix may be useful that lists clinical risks identified and

where they can be found in the risk management file and IFU


Notes on Coding Complaints

▪ Coding with IMDRF terms is a mandatory requirement for reportable incidents (MIR Form v7.2)▪ IMDRF 'Medical device problem codes’ (Annex A)

▪ IMDRF 'Health Effect' terms and codes (Annex E, F)

▪ IMDRF ‘Cause Investigation' terms and codes (Annex B, C, D)

▪ IMDRF Component codes (Annex G)

▪ Form also requires IMDRF codes for identifying similar incidents▪ IMDRF 'Medical device problem’ (Annex A)

▪ IMDRF ‘Investigation finding' (Annex C)

Note: Can use in-house codes instead during transition

▪ These codes may be useful for organizing complaints


Vigi lance Implementation Chal lengesand Solutions

Challenges Recommendations

Coding of complaints per IMDRF codes

Changing classification/coding of complaints on intake to match reporting form

Using legacy data to establish trending limits

Allow different rules for new product launches when there is insufficient data to establish good baseline valuesConsider linking to risk management expected levels

Complaint data allows for trending quantity of complaints but not severity of complaints

Coding of complaints can aid in distinguishing between severities of adverse events

Misalignment of labeling, risk, PMS data which requires extra reports

Conduct an integrated review of all data sources to ensure residual risks are appropriately captured in the labeling


Agenda


▪ PMS Planning

▪ PMS Reporting

▪ Now What?

▪ Q&A

42


PMS – Common NB findings

▪ Notified body findings and observations▪ Please provide complaints, sales, and the complaint rate per year

separately for EU and the ROW▪ Please provide information on any CAPAs associated with vigilance

activities▪ The search for vigilance did not include any international databases.

Only the FDA MAUDE database was searched▪ There is no explanation why the complaint rate is acceptable

▪ Suggestions and tips▪ Consider searching at least one international database▪ Provide PMS data for at least the last 3-5 years by year▪ Consider adding a justification for why the complaint rate is

considered acceptable instead of just stating that it is low


International databases

Recalls / FSCAs

• FDA recalls database (US) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

• BfArM Field Corrective Actions (Germany) https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html

• MHRA Alerts and Recalls (UK) https://www.gov.uk/drug-device-alerts

• SWISSMEDIC (Switzerland) https://fsca.swissmedic.ch/mep/#/

• ANSM (France) https://ansm.sante.fr/content/search?SearchText=device

• Health Canada Recall (Canada) Recall

• TGA Recall (Australia) https://www.tga.gov.au/recall-actions-database

Incidents / Adverse Events

• FDA MAUDE database (US) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

• BfArM Recommendations (Germany) https://www.bfarm.de/EN/MedicalDevices/RiskInformation/Recommendations/_functions/_node.html

• MHRA Alerts and Recalls (UK) https://www.gov.uk/drug-device-alerts

• Health Canada Medical Device Incidents (Canada) https://hpr-rps.hres.ca/mdi_landing.php

• TGA DAEN (Australia) https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html

https://www.gov.uk/drug-device-alerts

https://fsca.swissmedic.ch/mep/#/

https://ansm.sante.fr/content/search?SearchText=device

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/search-recherche/result-resultat?category_filter=0&health_products%5Bbrand%5D=&health_products%5Brecalling_firm%5D=&health_products%5Baudience%5D=0&vehicles%5Bmake%5D=0&vehicles%5Bvehicle_year_start%5D=0&vehicles%5Bvehicle_year_end%5D=0&vehicles%5Bvehicle_system%5D=0&vehicles%5Btransport_manufacturer%5D=&vehicles%5Btransport_recall_number%5D=&food%5Bawr_class%5D=0&all_any_search_text_1=all&search_text_1=contact+lens&logic_search_text_2=and&all_any_search_text_2=all&search_text_2=&logic_search_text_3=and&all_any_search_text_3=all&search_text_3=&all_any_exclude=all&exclude_search_text=&date_start=2015-01-01&date_end=2019-01-31&type=0&submit=Search

https://www.tga.gov.au/recall-actions-database

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

https://www.bfarm.de/EN/MedicalDevices/RiskInformation/Recommendations/_functions/_node.html

https://www.gov.uk/drug-device-alerts

https://hpr-rps.hres.ca/mdi_landing.php

https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx


PMS / PMCF Plan – Common NB findings

▪ Please provide a proactive PMS/PMCF Plan that is in line with the safety and performance objectives

▪ MDR excerpts

▪ For implantable and class III devices based on equivalence, “the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.”

▪ “The clinical evaluation…shall be updated throughout the life cycle of the device concerned with clinical data obtained from…implementation of the…PMCF plan…and the post-market surveillance plan

▪ MEDDEV 2.7/1 rev 4 excerpts

▪ “the notified body assesses the...PMS plan and PMCF plan…”


PMS / PMCF Plan – Recommendations

▪ Ensure that a MDR compliant PMS plan and PMCF plan is created and referenced in the CER▪ Refer to MDCG 2020-7 and -8 and GHTF MEDDEV 2.12/2 rev.2

▪ Keep in mind…clinical data obtained from PMS and PMCF studies are ▪ Not intended to replace the pre-market data necessary to demonstrate conformity▪ Intended to monitor clinical performance and safety throughout the expected lifetime of

the device, e.g., ▪ Uncertainties regarding medium and long term performance ▪ Safety under wide-spread use▪ Monitor residual risks such as undesirable side-effects and rare complications

▪ If PMCF is not conducted, ensure a sound justification based on data is provided. Consider elements in MEDDEV 2.12/2.

▪ Ensure the PMS/PMCF aligns with the objectives of the clinical evaluation and is statistically sound


PMS audit ready

▪ MDD Audit before May 26, 2020▪ Increased focus on PMCF and clinical evidence

▪ Companies (small and large) have lost CE marking due to lack of adequate PMCF (class IIa to class III devices).

▪ When you get a finding, you need to take it seriously ▪ Limited opportunities to respond (3 rounds of questions and then done)

▪ Don’t waste your first-round (and second round) response by trying to dress up a non-compliant plan


PMS audit ready

▪ MDR Audit or MDD Audit after May 26, 2020▪ Requires PMS and PMCF Plans for all products

▪ Specific to the product and the risk

▪ Expect to provide sample as part of the EU MDR NB application process

▪ Tip: Don’t put your strategic products at risk with a less than robust PMS/PMCF plan.

▪ PMS Reports or PSURs▪ They have been asked for in EU MDR audits

▪ If samples available, this has been adequate

▪ If samples are not available, have been able to show plan and timeline for completion without getting a finding

▪ Tip: Creating a sample report will help define whether the plans are executable. Data that should be readily available sometimes takes different forms requiring modifications to the plans or data collection systems.


Agenda


▪ PMS Planning

▪ PMS Reporting

▪ Now What?

▪ Q&A

49

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