To get and maintain market approval in the EU (CE marking under MDR), state-of-the-art (SOTA) literature review is part of the process and mandatory for all medical devices, going from low-risk class I to high-risk class III active, implantable devices.
SOTA literature review is part of the clinical evaluation process of a medical device, which is defined as an ongoing collection, generation, appraisal and analysis of clinical data related to the device. The output of this systematic literature review feeds into the clinical evaluation, risk management and instructions for use (IFU). It also provides relevant input for the design and setup of clinical investigations to ensure collection of sufficient clinical evidence to demonstrate conformity with the general safety and performance requirements (GSPRs) and the benefit-risk acceptability criteria.
A comprehensive, objective and thorough systematic literature review to describe the general SOTA and identify all relevant clinical safety, performance and usability data of the device under evaluation (and/or equivalent device) should comply with strict regulatory guidelines as per EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4.
In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review.
The SOTA literature review, as part of the clinical evaluation process, is a time-consuming complex process that requires specific reading, writing, and strong analytical skills.
At QbD Clinical, we provide knowledge-based expertise to help you set out the clinical strategy and plan and document the clinical evaluation process throughout the journey of your medical device – from start to finish.
To speed up the preparation of the required documentation and ensure high quality deliverables, a team of regulatory affairs specialists, literature review experts, medical writers, medical advisors and project managers work closely together.
Take advantage of the multi-disciplinary expertise of QbD Clinical to speed up and deliver an MDR compliant SOTA literature review and clinical evaluation in an efficient way.
Our services at a glance:
For help with any of the above, QbD Clinical can provide a solution. Our medical writers are determined to go the extra mile to serve your needs. Don’t hesitate to contact us.