Essentials of European Medical Device Regulatory Affairs - June 2020

Post Market Surveillance PMS

The PMS System • Requirement for all manufacturers • Appropriate for the device and risk class • Active, systematic process: – Gathering quality, performance and safety data

– Recording – Analysing – Reaching conclusions – Determining, implementing, monitoringCAPAs – Feedback into other processes

Continuous process through the product life cycle

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Sources of PMS

Pro-active

Inputs

Outputs

Technical Literature reviews Client investigations –failure analysis Registries (implants) Activedevice tracking PostCEclinical trials Experience onequivalent devices Maintenance reports

Manufacturers QMS:

Vigilance report

PMS

Updated IFU Design and /or Manufacturingchanges NewClinicalstudy Newsubmission

Complaint handling

FSCA

Quality Control Testing

Internal Productaudits Other bodies (theCA)

Vigilance

Risk Management

Service Returns WarrantyClaims Repairs FieldService User reactions during training programmes

FSN

Clinical Evaluation

CAPAs

Sales /Marketing Customer surveys SalesCall Feedback Postmarket study RepsorDistributorFeedback Experts user groups TheMedia SocialMedia–PatientGroups

Design Manufacture

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Post Market Surveillance PMS Article84 Post Market Surveillance Plan (Annex III):

Collection of information

•

• Characterisation of the performance of the device • Comparison with similar products • Suitable indicators and thresholds for risk benefit analysis • Methods /tools/protocols:

to investigate complaints

– –

Analysis of trends

– Communication with CAs, NBs, EOs and users – Tracing devices

• PMCF plan (or justification why not required)

TheOrganisation for Professionals in Regulatory Affairs

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