Author: Pawandeep Kaur Bollinger, PhD
Medical writing is often associated with pharmaceuticals, but its impact stretches far beyond. In the MedTech and combination product sectors, where innovation meets stringent regulatory demands, medical writing serves as the backbone of product development, compliance, and market success. This blog explores how specialized medical writing empowers MedTech companies to navigate complex regulatory landscapes, enhance communication with notified bodies, and drive patient safety.
What Makes MedTech Medical Writing Unique?
Medical writing in MedTech differs from traditional pharmaceutical writing due to the technical complexity of devices, integration of software/hardware, and evolving regulations like the EU Medical Device Regulation (MDR) and FDA’s 21 CFR Part 820. Having said that, medical writers comming from Pharma backgroungs can quickly indulge in production of regulatory documentation focused at Design history file (DHF), Risk management and user or patient centric CommunicationKey areas include:
♦Clinical Evaluation Reports (CERs), Technical Documentation (TD), and Post-Market Surveillance (PMS) reports must align with MDR/IVDR requirements.
♦Translating engineering data into risk-benefit analyses for regulators.
♦Creating clear instructions for use (IFUs) and patient-facing materials to minimize errors.
Peculiar Insight: Unlike drugs, even low-risk devices (Class I) under MDR require clinical evaluations, necessitating systematic literature reviews and evidence synthesis; a task where medical writers excel.
Can Medical Writing Drive MedTech Success?
Submissions to notified bodies often lack critical information, leading to delays. Medical writers structure TDs using standardized formats (e.g., eCTD, Annex II and III or STED format), ensuring clarity and completeness. Evenmore, writers synthesize data from preclinical studies, clinical trials, and post-market surveillance into cohesive CERs, addressing notified bodies’ expectations for safety and performance. Combination products (e.g., drug-eluting stents) require dual compliance with both device and pharmaceutical regulations. Medical writers could help Integrate drug-device interaction data into submissions or address unique labeling requirements (e.g., FDA’s 21 CFR Part 4).
Bridging the Gap with Notified Bodies
Notified bodies review thousands of pages of technical documentation. Medical writing could streamlines this process by providing "Standardizing Content". Using templates familiar to reviewers (e.g., IMDRF formats) to reduce confusion.
"Highlighting Critical Data" Summarizing safety and performance data upfront for faster assessment. And not to mention, "Leveraging Digital Tools" Platforms to automate TD submissions, ensuring compliance with digital MDR requirements.
For MedTech and combination product manufacturers, medical writing is not just a regulatory checkbox but it’s a strategic asset. By ensuring compliance, enhancing clarity, and fostering trust with notified bodies, skilled writers enable faster GTM effect goal, reduced costs, and safer patient outcomes.
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