Regulatory Insights and Writing Dilemmas in Medical Device Documentation

In contemporary medicine, the incorporation of advanced technologies has dramatically reshaped patient care, with medical devices becoming essential for healthcare professionals. These devices span a wide range, from basic syringes to sophisticated imaging systems and wearable sensors. Their development has been fuelled by numerous factors, including scientific discoveries, technological progress, and the increasing demands of healthcare services.¹

According to the United States (US) Food and Drug Administration (FDA), medical devices are any instrument, machine, contrivance, implant, and in vitro reagent besides drugs used for diagnostic and therapeutic purposes in humans or animals. ²

The pharmaceutical and medical device industries are subject to different regulatory frameworks due to their interdependence. Notwithstanding their similarities, medical writing and clinical research are affected by the fundamental distinctions between medications and medical devices. The most important stage of a medical device’s development and a need for launching one on the market is regulatory approval. The safety and effectiveness of medical devices are regulated by organizations like the Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and Health Canada, which operate under stringent laws.

An Overview of Key European Regulations

Both drugs and devices are subject to the Declaration of Helsinki, all general guidelines pertinent to medical writing (e.g., the Consolidated Standards of Reporting Trials [CONSORT] statement, Good Publication Practice for Company Sponsored Medical Research (GPP2022)], and the necessity of trial registration (e.g. www.Clinicaltrials.gov).

Clinical trials are referred to as “clinical investigations” under the Medical Device Regulation (MDR) (Articles 2 (45), 62–82 Annex XV). The MDR’s guidelines for clinical investigations are derived from BS EN ISO 14155:2011, which was revised in 2020. Additional guidelines are available in Medical Device Coordination Group (MDCG) 2021-6. The European Commission website has the guideline documents MDCG 2020-10/1 (Safety reporting in clinical trials of medical devices under the Regulation EU 2017/745)10 and MDCG 2020-10/2 (Clinical Investigation Summary Safety Report Form v1.0).³

Legal Differences Between the EU and the United States

The regulatory landscape for medical devices in the EU and the US presents notable differences. In the US, the FDA acts as the sole regulatory authority overseeing medical devices, pharmaceuticals, and biologics. In contrast, the EU separates responsibilities: the European Medicines Agency (EMA) handles pharmaceuticals and biologics, while medical devices are regulated through a network of Notified Bodies. As of March 2023, there are 38 Notified Bodies designated under the Medical Device Regulation (MDR), each supervised by the competent authority of their respective EU member state.

Although the MDR applies uniformly across the EU, the involvement of multiple competent authorities and Notified Bodies can lead to variations in how requirements are interpreted. To address this, the MDCG has issued guidance documents to enhance clarity and consistency.

In terms of market presence, FDA approval does not impose an expiration on a device’s availability in the US, except in cases of recall. Conversely, in the EU, a CE mark is valid for a limited period, typically five years, after which the device must undergo a renewal process to maintain its market authorization.⁴

Differences in the Post-Market Requirements Between the EU and the US

The post-market requirements for medical devices differ significantly between the EU and the US. In the US, the FDA’s post-market obligations are relatively general. Most devices require only basic post-market activities, such as collecting feedback from healthcare professionals or accessing the Manufacturer and User Facility Device Experience (MAUDE) database. For certain class II and high-risk class III devices, a post-market clinical study might be necessary under FD&C Act Section 522. As of March 2023, the ‘522 Post-market Surveillance Studies Database’ listed 21 ongoing studies, with only two pertaining to orthopaedic devices.

In contrast, the EU’s MDR imposes more stringent post-market surveillance requirements. Manufacturers must actively and systematically gather post-market data and submit Periodic Safety Update Reports (PSURs) annually or biennially, depending on the device’s risk class. For implantable and Class III devices, PSURs must be submitted to and evaluated by the Notified Body. Additionally, for devices with insufficient clinical data, those approved via the equivalence pathway, or lacking long-term data, manufacturers are required to conduct Post-market Clinical Follow-up (PMCF) activities. This often means conducting a PMCF study, unless alternative data sources, such as registries, provide adequate information to address questions from the risk management file or clinical evaluation report.⁴

Navigating Medical Device Regulations in India

However, the Indian regulatory framework for medical devices has become increasingly active in recent years. The Medical Devices and Diagnostics Division of the Central Drug Standard Control Organisation (CDSCO) introduced the Indian Medical Device Rules (IMDR) in January 2017, which took effect in January 2018. These rules were later amended in February 2020 as the “Medical Devices (Amendment) Rules, 2020,” which came into force in April 2020, introducing a new requirement for the registration of certain medical devices.

While many medical devices are still regulated as drugs under the Drugs and Cosmetics Act, 1940, the introduction of the IMDR and supporting guidelines marks India’s initial step towards improving patient safety in relation to medical devices. Future amendments to the IMDR can address existing gaps, aligning these regulations more closely with the Medical Device Reporting (MDR) and In Vitro Diagnostic Regulation (IVDR) of the EU, which are the latest international standards for ensuring the safety and performance of medical devices.⁵

Exploring the Link Between Medical Writing and Medical Devices

Over the course of a medical device’s existence, medical writing and devices are closely related. Medical writers work directly with scientists, engineers, physicians, and regulatory specialists at every stage of product development and post-market surveillance to guarantee documentation is accurate, consistent, and compliant.

Moreover, the medical device sector relies heavily on medical writing to spread knowledge and make breakthroughs. Writing scientific articles that convey the results of research investigations and clinical trials is the responsibility of medical writers. These publications are an invaluable tool for medical professionals, allowing them to stay abreast of the most recent advancements in medical technology and make well-informed judgments about patient care.

Medical writers not only write for scientific articles but also help create patient information leaflets. These leaflets hand over patients with crucial details regarding medical gadgets, guaranteeing that they comprehend the intent, application, and any hazards of the item. Medical writers enable patients to take an active role in their treatment by offering precise and easily understandable information that helps them make educated decisions about their healthcare. ⁶

Table: Lists some of the documents required for pharmaceutical products and medical devices throughout the various stages of the product lifecycle.³

Challenges in Medical Writing for Manufacturers

Shifting Trends in Regulatory Standards

One of the most common challenges is keeping up with the evolving regulatory landscape. A prime example is the introduction of the European Union Medical Devices Regulations (EU MDR) 2017/745 and EU IVDR 2017/746. These regulations have substantially changed the scope of data and scientific documentation requirements. For instance, the Clinical Evaluation Plan (CEP) now includes a Clinical Development Plan (CDP), and the Post-market Surveillance (PMS) system has expanded to include PMS plans, reports, vigilance reports, PSUR, and post-market clinical/performance plans and reports. To stay successful, it is crucial for medical writers to undergo regular training and remain updated on these changes.

The Deficit of Medical Writers

Finding a qualified medical writer for regulatory writing is increasingly challenging today. Beyond a strong grasp of regulatory compliance, these writers must also be skilled in presenting and summarizing data effectively. They need to understand the technical details of medical devices, including their design, components, safety features, and efficacy. To address this issue, one potential solution is to diversify the pool of employed medical writers or consider outsourcing this expertise.

Quality Assurance

The documents submitted for regulatory approval must meet high standards of quality, requiring accuracy, clarity, and consistency. Achieving this can be challenging. The best approach to ensure quality is to conduct frequent reviews and make necessary revisions.

Time Constraints

Regulatory approvals frequently involve strict deadlines and limited time for review and revisions. It is essential to promptly identify and resolve potential issues with the submitted documents to adhere to the required timeline.⁷

References

1. Abbas, Asad. (2024). Revolutionizing Patient Care: The Role of Medical Devices in Modern Medicine.
2. Tettey, Felix & Parupelli, Santosh Kumar & Desai, Salil. (2023). A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity. Biomedical Materials & Devices. 10.1007/s44174-023-00113-9.
3. Mallia, Roderick, and Beate Walter. “Differences between writing for medical devices and pharmaceuticals: An update.” Medical Writing31 (2022): 12-20.
4. Fink, Matthias, and Bassil Akra. “Comparison of the international regulations for medical devices–USA versus Europe.” Injury54 (2023): 110908.
5. Manu, Manas, and Gaurav Anand. “A review of medical device regulations in India, comparison with European Union and way-ahead.” Perspectives in clinical research13.1 (2022): 3-11.
6. https://www.rxcomms.com/learning/the-importance-of-medical-writing-in-medical-devices
7. https://www.freyrsolutions.com/blog/top-5-obstacles-encountered-by-manufacturers-in-medical-writing

Authors:

Saurabh Shukla, Masters of Pharmacy
Scientific Writer 1, Enago Life Sciences
Connect with Saurabh on LinkedIn

Dhanya Mukundan, MDS (Oral Medicine and Radiology)
Expert Scientific Writer, Enago Life Sciences
Connect with Dhanya on LinkedIn

Raghuraj Puthige, PhD., eMDP
Function Head, Medical Communications – Enago Life Sciences
Connect with Raghuraj on LinkedIn