GLOBAL offers a range of writing solutions to address new medical device regulations. The European Medical Device Regulation (EU MDR) formally went into effect on May 26, 2021, replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), and currently governs the production and distribution of medical devices within the European Economic Area (EEA).
Under the new regulation, all medical devices regardless of classification are required to undergo clinical evaluation. This process includes the development of a Clinical Evaluation Plan (CEP), as well as the completion of a Clinical Evaluation Report (CER) containing a thorough appraisal and analysis of all relevant clinical data, and conclusions outlining the continued safety and performance of the subject device.
EU MDR Deliverables We Write
Clinical Evaluation: CEP, CER
Post-Market Surveillance: PMS Plan, PMS Report, PSUR
Post-Market Clinical Follow-up: PMCF Plan, PMCF Report
Patient and HCP Facing Documents: SSCP, IFU, PIL
Technical Documentation Compilation
Why Choose GLOBAL?
Many manufacturers underestimate the difficulty of preparing MDR ready submissions and as a result are drawn into extensive back and forth discussions with the notified bodies and expensive last minute remediations. Setting an effective strategy and working with a quality vendor well-versed in EU MDR can streamline document preparation, improve quality, and ultimately lead to significant savings.
GLOBAL has extensive experience with EU MDR and can ensure that your MDR submissions are compliant with all applicable regulatory requirements and best practices. Our team of 30+ writers and consultants has been writing CERs since 2015 and has subject matter expertise in the following therapeutic areas: cardiology, vascular & interventional radiology, orthopedics, respiratory medicine, nephrology, neurology, urology, gynecology, ophthalmology, and more. Each year, we complete over 100 successful projects related to EU CE marking, including new product submissions, annual updates, remediations, and regulatory responses and negotiations.
We use a team approach for resourcing your writing project, where all deliverables are managed by an experienced project manager and written by subject matter experts who are up to date on current regulations and guidance.