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Medical Devices Postmarket Surveillance in Europe updated


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

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Medical Devices Postmarket Surveillance in Europe updated

  1. 1. Annet Muetstege Postmarket Surveillance made simpel| Westervoort, 29 December 2013
  2. 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. 3. Medical Devices: a diverse sector 29 Dec 2013 ACS PMS 3
  4. 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. 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. 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. 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. 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. 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. 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. 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. 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. 13. Questions? Applied Clinical Services BV +31 26 848 5281 29 Dec 2013 ACS PMS 13
  14. 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