Premarket Clinical Evaluation under the EU MDR proposal
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Premarket Clinical Evaluation under the current version of the European Medical Device Regulation proposal. What are key elements and how does it impact the clinical evidence needs?

Premarket Clinical Evaluation under the current version of the European Medical Device Regulation proposal. What are key elements and how does it impact the clinical evidence needs?

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Premarket Clinical Evaluation under the EU MDR proposal Presentation Transcript

  • 1. Clinical Evaluation under the proposed EU regulation for Medical Devices| Westervoort, 05 January 2014 Annet Muetstege
  • 2. Medical Devices: a diverse sector 05 Jan 2014 ACS Premarket Clinical Evaluation 2
  • 3. Proposed EU MDR – Dec 2013 • Current version proposed regulation on Medical Devices ► Active Implantable Medical Devices and Medical Devices Directive combined ► Regulation ► (re)Classification – more Class III medical devices ► Includes requirements on Premarket Clinical Evaluation, Postmarket Clinical Follow-Up, and Clinical Investigations • Timelines ► EU Council debate 10/12/2013 ► EU Parliament elections May 2014 ► Entry into force 2015? 05 Jan 2014 ACS Premarket Clinical Evaluation 3
  • 4. Clinical Evaluation • Demonstration of clinical benefit needed for all devices: ″ ‘clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and, performance and clinical benefits of the device when used as intended by the manufacturer. • Main drivers clinical evidence needs for the clinical evaluation ►Class of device ►Available relevant clinical evidence ►Claims including the intended population ►Primary market 05 Jan 2014 ACS Premarket Clinical Evaluation 4
  • 5. Medical Device Class • Class IIb and III need a Clinical Trial: ″ In the case of devices falling within Article 43a(1), with the exception of those used for a short term, clinical investigations shall be performed … • Clinical Trial should be a RCT: ″ As randomised controlled investigations usually generate a higher level of evidence for clinical efficacy and safety, the use of any other design or study has to be justified. 05 Jan 2014 ACS Premarket Clinical Evaluation 5
  • 6. Existing Clinical Evidence • More specific and independent sources of existing clinical data for the clinical evaluation are needed: ″ Data from independent scientific institutions or medical societies based on their own collections of clinical data shall also be taken into account. • Using existing clinical evidence, device equivalence on intended purpose and device characteristics should be clear: ″ Equivalence can only be demonstrated when the device that is subject to clinical evaluation and the device to which the existing clinical data relates have the same intended purpose and … characteristics of the devices and the medical procedures … not a clinically significant difference in the safety and performance of the devices. 05 Jan 2014 ACS Premarket Clinical Evaluation 6
  • 7. Claims • In case a Clinical Trial is needed, also clinical evidence on efficacy in the intended patient population is required: ″ Clinical investigations shall be … defined in such a way as to confirm or refute the technical performance of the device, the clinical safety and efficacy of the device when used for the intended purpose in the target population and in accordance with the instructions of use, and the manufacturer's claims for the device … 05 Jan 2014 ACS Premarket Clinical Evaluation 7
  • 8. Primary market • Standard of Care and therefore control therapy tends to differ by country and expert • RCT needs design according to best clinical practices in primary market: ″ As randomised controlled investigations usually generate a higher level of evidence for clinical efficacy and safety, the use of any other design or study has to be justified. Also the choice of the control intervention shall be justified. Both justifications shall be provided by independent experts with the necessary qualifications and expertise. 05 Jan 2014 ACS Premarket Clinical Evaluation 8
  • 9. Conclusion • Current version of the European Medical Device Regulation demands a more extensive clinical evidence base for the Premarket Clinical Evaluation on devices. • References: ► Propsed EU regulation: http://ec.europa.eu/health/medicaldevices/files/revision_docs/proposal_2012_542_en.pdf ► EU Parliament adopted amendments: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&referenc e=P7-TA-2013-428 ► Consolidated proposed MDR: https://dl.dropboxusercontent.com/u/15083837/Consolidated%20Version%20prop osal_2012_542_en%20medical%20devices%20Word.pdf 05 Jan 2014 ACS Premarket Clinical Evaluation 9
  • 10. Questions? Applied Clinical Services BV www.appliedclinicalservices.com info@appliedclinicalservices.com +31 26 848 5281 05 Jan 2014 ACS Premarket Clinical Evaluation 10
  • 11. 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 05 Jan 2014 ACS Premarket Clinical Evaluation 11