Medical Device Postmarket Surveillance and Clinical Follow-up under the proposed European Medical Device Regulation updated according to the latest amendments.

1. Annet Muetstege
Postmarket Surveillance made simpel|
Westervoort, 29 December 2013

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
29 Dec 2013
ACS PMS
2

3. Medical Devices: a diverse sector
29 Dec 2013
ACS PMS
3

4. 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 collect
and 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 postmarket 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 …
29 Dec 2013
ACS PMS
4

5. Medical Device Regulation Proposal 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 from
users, 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 that
shall be part of the technical documentation and be sent
periodically to the concerned Member States. For class III
medical devices, the manufacturer's PMCF evaluation
report shall be reviewed by a third party or external expert
…
29 Dec 2013
ACS PMS
5

6. Medical Device Regulation Proposal 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.
29 Dec 2013
ACS PMS
6

7. 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
29 Dec 2013
ACS PMS
(1) MEDDEV 2.12-1 rev 8
7

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
29 Dec 2013
ACS PMS
8

9. 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.
29 Dec 2013
ACS PMS
9

10. PMCF – Registry
• Options – several
►Paper/ EDC forms
►Single/ multi center
►…
• Advantages
►Value for money
►Low site threshold
►…
• Challenges
►No efficacy/ added value data
29 Dec 2013
ACS PMS
10

11. 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
29 Dec 2013
ACS PMS
11

12. Postmarket Surveillance Conclusion
• PMS under new MDR
►More stringent, and controlled
• Various options
►Standard company processes
►Literature review
►Registries
►Randomised Controlled Studies
►…
29 Dec 2013
ACS PMS
12

13. Questions?
Applied Clinical Services BV
www.appliedclinicalservices.com
info@appliedclinicalservices.com
+31 26 848 5281
29 Dec 2013
ACS PMS
13

14. 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 Planning
What, where, when, how
►Clinical evidence communication
Reports, abstracts, M&S material and training
►Clinical project management
Project design, progress, and (co-)monitoring
29 Dec 2013
ACS PMS
14