Medical Devices Postmarket Surveillance in Europe updated

Annet Muetstege

Postmarket Surveillance made simpel|

Westervoort, 29 December 2013

29 Dec 2013 ACS PMS 2

Reportable Adverse Event?

1. Serious?

2. Device related?

3. Unanticipated?

Medical Device Directive > when 1, 2, and 3 apply

Current version Medical Device Regulation > when 2 applies


Medical Devices: a diverse sector


Medical Device Regulation Proposal -

Postmarket Surveillance

″ Proportionate to the risk class and the type of device, manufacturers …shall institute and keep up to date a systematic procedure to collectand review experience gained from their devices placed on the market… and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’.

″ Part of the post-market surveillance plan shall be a plan for post-market clinical follow-up in accordance with Part B of Annex XIII.

″ Post-market clinical follow-up, … a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer's post-market surveillance plan… the manufacturer shall proactively collect, register in the electronic system on vigilance referred to in Article 62, and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose … with the aim of confirming the safety and performance throughout the expected lifetime …



Postmarket Clinical Follow-up (1)

″ The PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.″ the general methods and procedures of the PCMF to be applied,

such as gathering of clinical experience gained, feedback fromusers, screening of scientific literature and of other sources of clinical data;

″ The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report thatshall be part of the technical documentation and be sent periodically to the concerned Member States. For class III medical devices, the manufacturer's PMCF evaluationreport shall be reviewed by a third party or external expert …



Postmarket Clinical Follow-up (2)

″ The notified body shall periodically, at least once every 12

months, carry out appropriate audits and assessments to

make sure that the manufacturer applies the approved

quality management system and the post-market

surveillance plan.


PMCF - Vigilance

″ … European system for the notification and

evaluation of incidents and field safety corrective

actions …

• Advantage

►Existing company system

►Low additional cost

• Challenges

►Reactive

►Issues late in the game

(1) MEDDEV 2.12-1 rev 8


PMCF - Literature review

″ The process of reading, analyzing, evaluating, and summarizing scholarly materials about a specific topic.

• Options►Review relevant sources at regular intervals, e.g. PubMed

►Conferences

► Journal alerting Services

• Advantage►Relatively cheap

►Access to data world wide

• Challenges►Reactive

►Data typically limited and heterogeneous


PMCF - Studies

• Options

►Non-interventional – registries

″ A collection of clinical data where all subjects receive the standard hospital treatment and have a parameter of interest in common.

►Interventional – RCT

″ Clinical study where participants receive treatment's or test's different from standard practice because of study participation. Such treatment may concern randomization.


PMCF – Registry

• Options – several

►Paper/ EDC forms

►Single/ multi center

►…

• Advantages

►Value for money

►Low site threshold

►…

• Challenges

►No efficacy/ added value data


PMCF – Interventional Study

• Options

►Small scale single arm

►RCT

• Advantages►Efficacy and/ or added value

►RCT is gold standard

• Challenges►Not daily practice

►Huge investment

►Blinding


Postmarket Surveillance -

Conclusion

• PMS under new MDR

►More stringent, and controlled

• Various options

►Standard company processes

►Literature review

►Registries

►Randomised Controlled Studies

►…


Questions?

Applied Clinical Services BV

[email protected]

+31 26 848 5281


Applied Clinical Services BV

• Co-founded by Annet Muetstege

• Mission► To contribute to better patient outcomes in health care by partnering with medical

device industry and ensuring that product safety & efficacy claims are supported by

adequate clinical evidence in the most cost-effective manner

• Core services

►Strategic Clinical Evidence PlanningWhat, where, when, how

►Clinical evidence communicationReports, abstracts, M&S material and training

►Clinical project managementProject design, progress, and (co-)monitoring

Medical Devices Postmarket Surveillance in Europe updated

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