Premarket Clinical Evaluation under the EU MDR proposal

Clinical Evaluation under the proposed

EU regulation for Medical Devices|

Westervoort, 05 January 2014

Annet Muetstege

05 Jan 2014 ACS Premarket Clinical Evaluation 2

Medical Devices: a diverse sector


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?


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


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 useof any other design or study has to be justified.


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 societiesbased 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.


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 whenused for the intended purpose in the target populationand in accordance with the instructions of use, and the manufacturer's claims for the device …


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.


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/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

► EU Parliament adopted amendments: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-428

► Consolidated proposed MDR: https://dl.dropboxusercontent.com/u/15083837/Consolidated%20Version%20proposal_2012_542_en%20medical%20devices%20Word.pdf


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

Premarket Clinical Evaluation under the EU MDR proposal

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