CER Content: CER Updates:

CE Mark
• clinical evaluation, results of the clinical evaluation, • Whenever new information received from PMS that has potential to change the current evaluation;
and the clinical evidence derived from it • Annually if the device carries significant risks or is not yet well established
CEP • Every 2-5yrs if the device is not expected to carry significant risks and is well established
Refine CE Plan as necessary

Clinical Evaluation Process

CER CER CER CER CER (see MEDDEV 2.7/1) CER CER
Pre-market Clinical Investigation
(Generally required for
Class III and implantables)
Clause (33)

Article
Risk Management Process 61.11 Risk Management Process

Article 83.3 and

Annex 1.3 (e)&(f)
PMCF Eval
Report Refine PMS/PMCF Plans as necessary
PMS Plan PMCF PMCF is a continuous proactive sub-process within the PMS system that updates the Clinical Evaluation
(including PMCF plan)
Post Market Surveillance Process (including PMCF process)
(PMCF Study
if needed) PSUR/ PSUR/ PSUR/ PSUR/ PSUR/
PMS Report PMS Report PMS Report PMS Report PMS Report
Articles
2.60 and 83.3

CAPA PROCESS
CE Mark

DESIGN / MANUFACTURING CHANGES

Analysis:
Summary of Safety and Clinical Performance (SSCP)
PMS PLAN: PMS data sources: • A standalone summary to be publicly available on Eudamed
• Description of system to collect & assess PMS data  Info from Vigilance System: Content: • For implantables and class III devices only
• How the assessed data feeds into the RM process – serious incidents PMS Reports • PMS data analysis • To be updated at least annually
• Complaint investigations – field safety corrective actions • Update as needed • any CAPA taken • See Article 32 for contents
• System for reporting and addressing trends  information from PSURs
Class i
• Communication with stakeholders  Records of non-serious incidents
• System for actioning issues, including CAPA  data on undesirable side-effects
• Traceability System  trend reporting (non-serious or
• PMCF plan or justification why PMCF not applicable expected) (e.g. thru use of surveys) Class iia, iib, iii Content
 literature (technical, specialist), PSURs • PMS data analysis
databases, registers • As necessary or every 2yrs (iia) • any CAPA taken
 feedback and complaints • conclusions of benefit-risk determination
• Update every year (iib/iii) • main findings of PMCF
 Public information on similar devices
PMCF PLAN (part of PMS plan) – see MDCG 2020-7 for guidance • Sales and market size information
PMCF plan specifies how you will collect and evaluate clinical data from the CE marked device.
Doesn’t need to be a clinical study – can range from an analysis of existing data to performing a new clinical study:
• Documented methods of PMCF & rationales and time schedule
• Methods for proactively collecting and evaluating clinical data for:
NOTE: PMCF sequence shown in green is presented as a once-off occurrence at time of CE Marking
– a) confirming the safety and performance of the device throughout its expected lifetime, PMCF Evaluation Report (part of CER) – see MDCG 2020-8 for guidance - this is for purposes of diagram clarity only. In practice, PMCF is continuously running throughout
– (b) identifying previously unknown side-effects and monitoring identified side-effects & contraindications, • Update at least annually for implantables and class iii the lifetime of the device and seeks to continuously confirm the safety and performance of the
– (c) identifying and analysing emergent risks on the basis of factual evidence, • Update frequency for all else unclear (would it be same as PSUR/PMS reports?) device and to proactively identify any emerging risks and to feed this into the Clinical Evaluation.
– (d) ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I,
– (e) identifying possible systematic misuse or off-label use, so as to verify if intended purpose is correct
• General methods & rationale If not performing PMCF, a justification is required (e.g. CE not raising any questions/concerns that
• Specific methods & rationale may impact the existing benefit/risk ratio)
• Evaluation of clinical data relating to equivalent or similar devices