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For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation is a comprehensive and systematic literature search which is performed to identify suitable clinical data that is not available from [...]

There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously monitor and update your products’ risk-benefit analysis.     Because of the broad sweeping nature of the updated EU MDR, [...]

Breaking Down EU MDR Implementation for Class 1 Medical Devices   Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I medical devices in the lowest risk class must also conform to the new European Medical Device Regulation (EU MDR) to [...]

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive actions should also be simultaneously integrated in CAPA management for best outcome.   Corrective and preventive actions (CAPA) should seamlessly [...]

Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation report assesses a medical device’s benefit-risk profile to ensure its continued safety, efficiency, and compliance. A critical part of the [...]

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product.   Literature reviews are essential for manufacturers to ensure that the IVDR has been constructed according to current regulatory requirements and that it is based [...]

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures in place to verify and guarantee the regulatory compliance of products and to establish processes and appropriate measures for diminishing [...]

EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but steady transfer of MDD to MDR, various aspects of requirements regarding medical device regulation are changing every day. With that comes new regulations and, with that, new documents for us [...]

The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published by the EU comes with some new rules for the manufacturer. Medical manufacturers will now have to submit a summary of safety and clinical performance (SSCP) for their products. This [...]

A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references to a specific subject.   Literature searches serve many functions for a medical manufacturer, including obtaining data necessary to create evidence-based recommendations and design, data regarding the device technology's effectiveness, and risk assessments. [...]