Compared to the old Directives, the new Medical Device Regulation (MDR) reinforces important factors and provides additional requirements concerning the process of clinical evaluation.
Since clinical evaluation has always been a major critical activity for medical device manufacturers, regardless of the size of a company’s business or on the types and classes of medical devices that it develops, with a significant impact on the R&D budget and on timing for obtaining the CE-mark, 1MED experts prepared a detailed expert guidance focusing on clinical data and clinical evidence new requirements set by the new MDR now available for download.
This Expert Guidance has been written with the intent to help manufactures in understanding the new MDR requirements for clinical data and clinical evidence, and to clarify major gaps between the old Directives, MDR and MEDDEV 2.7/1:2016 guideline, also with reference to legacy devices CE marked under the Medical Device Directive.
This guidance discusses new provisions regarding clinical data and their critical evaluation, and clarifies what sufficient clinical evidence means under the MDR.
What you will learn from this Expert Guidance is summarized in the following main topics further addressed in the full document:
- The update of the “clinical data”, “clinical evidence” and “clinical evaluation” definition by MDR
- The practicability of the equivalence route under the MDR,
- The requirements for an MDR-compliant clinical evaluation, especially concerning legacy devices,
- The requirements for clinical data of medical devices without an intended medical purpose (MDR Annex XVI),
- The use of clinical data of similar medical devices,
- The MDR requirements for PMCF, in the context of PMS activities.
Interested in understanding more? Download your free copy of 1MED’s Expert Guidance to understand how to comply with the new MDR clinical data and clinical evidence requirements.
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Complying with the MDR provisions requires significant investments for manufacturers, as adequate resources and proper competences have to be allocated – both for initial CE-marking and for certification maintenance.
In 1MED, thanks to our extensive experience in clinical evaluations and equivalence determination, we can help you understand what clinical data are needed to comply with MDR requirements for clinical evidence, as well as to bridge the gap with respect to clinical data requirements for your legacy devices, and with the design of a proper data collection strategy.
We can also support you in conducting clinical investigations and updating clinical evaluations throughout the entire life cycle of your medical devices.
For more information on our regulatory and clinical services, please contact us at firstname.lastname@example.org