November - 20198In My OpinionTHE IMPACT OF THE EU MEDICAL DEVICE REGULATION ON CLINICAL DATA REQUIREMENTSBeata Wilkinson, Medical Director, Cactus CommunicationsByIn May 2017, the EU Medical Device Regulation (MDR) entered into force and, on May 26th, 2020, will apply directly to all the Member States. This regulation is bringing numerous changes, mandating that manufacturers prepare to meet the new requirements in time. In particular, manufacturers must prepare for the transition to MDR's greater clinical evidence requirements.Clinical evaluation will need to be performed on all medical devices destined for the EU market. MDR defines clinical evaluation as: "a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer". Clinical evaluation will be conducted with the aim of collecting, appraising and analysing all relevant clinical data. The clinical evaluation, its results, and the clinical evidence derived from it will be documented in a clinical evaluation report (CER). The main sources of clinical data will be clinical investigation(s), reports published in peer-reviewed scientific literature, other clinical experience, and post-market surveillance, in particular post market clinical follow-up (PMCF). While in the past, reliance on clinical data generated by equivalent devices was widespread, under MDR it will be made much more difficult as it will be necessary to either enter into a contract with the manufacturer of the equivalent device (class III and implantable devices) or ensure sufficient levels of access to the data relating to the equivalent device on an ongoing basis (other classes of devices).The EU MEDDEV 2.7/1 Rev 4 guide on clinical evaluation introduced a recommendation for a planning stage to ensure preparation of compliant CERs. The MDR will place an even stronger emphasis on the importance of early planning. While there are certain aspects of the Clinical Evaluation Plan (CEP) that are common to both the MEDDEV guide and the MDR, there are many additional requirements in the MDR. These include (selected highlights only): a detailed description of
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