The document summarizes the proposed EU regulation for medical devices which would combine existing directives and require more extensive premarket clinical evaluation for class IIb and III devices. It outlines that clinical trials would be needed to demonstrate safety, efficacy and intended use in the target population according to claims. Existing evidence and device equivalence must also be established, with controls and trials designed based on best practices in the primary market. The regulation aims to demand a higher level of clinical evidence for medical device approval.

1. Clinical Evaluation under the proposed
EU regulation for Medical Devices|
Westervoort, 05 January 2014
Annet Muetstege

2. Medical Devices: a diverse sector
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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?
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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
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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.
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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.
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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 …
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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.
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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
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10. Questions?
Applied Clinical Services BV
www.appliedclinicalservices.com
info@appliedclinicalservices.com
+31 26 848 5281
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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
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