How device regulation and documents compare with a medicine's
A medical device differs from a medicine in its endpoints, its lifecycle and the evidence it needs, and it answers to its own regulatory framework, vocabulary and documents, most of which have a pharmaceutical counterpart. Writing about a device also calls for technical knowledge of how the product works.
The products and their evidence
The inherent differences between devices and drugs have implications for clinical research and medical writing. The features that set devices apart from drugs may shape the kind of activities a medical writer is required to support. To one physician, it is all medicine in the end, and medicines and devices are different tools for improving the patient's outcome. One writer sees them as different in regulation and in how medical writers handle them, but in reality as different tools for making the patient better.
Devices range in complexity from tongue depressors through implantable pacemakers to in vitro diagnostic devices found in doctors' surgeries or large laboratories. Research study designs and data endpoints differ between devices and pharmaceuticals. Clinical studies of pharmaceuticals focus on proving safety and efficacy relative to the agent's intended purpose, but device endpoints are as diverse as the devices themselves; for example, therapeutic devices must prove safety and efficacy, measurement devices precision and validity, and diagnostic devices sensitivity and specificity. Device performance outcomes and safety are often highly dependent on the experience and skill of the user.
In the view of one device writer, demonstrating effectiveness calls for different kinds of studies: the clinical investigation required for initial CE marking, which depends on the product, and post-market clinical follow-up studies, which demonstrate clinical performance, effectiveness, safety and the benefit-risk ratio. As with drugs, the studies needed depend on the product, its classification and its type. Devices vary enormously. A study of an MRI scanner involves radiation, a study of a guide wire involves its operator, and a nicotine patch differs again in how it is used and what it is intended for, so each calls for a completely different type of study.
Devices undergo continuous and rapid innovation and so have a short product life cycle, while pharmaceuticals undergo continuous but slower innovation and so have a longer one. In 2019 devices went from development to market in three to seven years, and technological improvements were typically available within two years of a previous iteration, whereas improvements in medicines might take 10 to 20 years.
In 2026 drugs, devices, diagnostics and digital tools were coming together in healthcare. Both sectors aim to improve patient outcomes through innovation and evidence-based products, but in 2026 they differed in structure and regulation in these ways:
- Lifecycle: medicines follow a linear, trial-based model through phases I to IV, while devices often evolve iteratively, with design changes and post-market updates.
- Evidence: drug approvals hinge on robust clinical data demonstrating safety and efficacy, so clinical trials are invariably required, while devices, especially lower-risk ones, may rely more on analytical performance, usability testing and real-world evidence. Clinical investigations are generally needed mainly for high-risk and de novo devices, and literature data are a crucial source of evidence for devices of every class, much more than in pharma.
- Stakeholders: pharmaceutical writing often addresses regulators and clinicians, while device writing may also involve engineers, usability experts and software developers. Patient input into study design is more common for medicines than for devices.
- Framework: the route to market for medicines is quite similar worldwide, with standardised requirements and documents in the Common Technical Document, except for certain regional mandates, while device pathways can differ drastically by country or region, with limited global standardisation.
- Transparency: the pharmaceutical industry is well versed in clinical data transparency and sharing, with well-established systems and clear requirements and guidelines, while the device industry is still at a nascent stage in these processes.
Regulation in each industry
The device and pharmaceutical industries are related, but each is governed by its own regulatory system. Legislation differs between the two industries: the pharmaceutical industry is heavily regulated, in the USA by the Food and Drug Administration, in Europe by the European Medicines Agency, and by each country's own competent authority, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Compliance with device legislation is also the responsibility of the national competent authorities, and in 2016 that legislation was less demanding but likely to become appreciably more so in response to calls for greater safety monitoring. These differences were reflected in the lead time from development to market, which in 2016 averaged 13.9 years for drugs in the USA and UK against an estimated three to seven years for medical devices.
In 2019 the device industry's regulatory system was just as demanding and scrutinising as the pharmaceutical industry's. In 2019, after recent scandals, both industries needed quality, peer-reviewed, validated documents.
A writer who moved from pharmaceuticals to devices found the guidance on good clinical practice, informed consent forms, reports and protocols almost like for like, and found that devices too need qualified writers, peer-reviewed quality control of documents and a quality management system.
By 2022 the pharmaceutical industry had long had the International Council for Harmonisation (ICH) guidelines, the CORE Reference manual and well-established, accessible document templates, while the device regulatory environment and its guidance were relatively young and not as well structured. A writer with a pharmaceutical background may feel that the device regulatory environment only recently started to catch up with the clinical regulatory environment. The structural differences between the two were particularly evident in the early days of device trials and documentation, especially before the implementation of the EU Medical Device Regulation (MDR). With growing experience, and as the notified bodies published guidance documents and position papers, the device industry was by 2022 becoming more structured and specific. Guidance documents and feedback from notified bodies have been crucial in bringing clarity. The move toward more stringent device requirements was bringing the device environment closer to that of the highly regulated pharmaceutical industry.
The device and pharmaceutical vocabularies
Device work uses its own names for pharmaceutical concepts: a clinical investigation is a clinical trial or study, intended use corresponds to indication, clinical performance to efficacy, the instructions for use to the summary of product characteristics, an adverse device effect to an adverse drug reaction, an unexpected serious adverse device effect to a suspected unexpected serious adverse reaction (SUSAR), and pharmacovigilance to vigilance. The MDR itself refers to clinical trials as clinical investigations. Adverse events are similar for drugs and devices, with slight differences in definition.
The pharmaceutical and device worlds can be said to be coming together, and a writer who understands both, with their many differences and similarities, can communicate with both, speak both languages, bridge the knowledge gap and translate specific terms. One writer is often asked whether a clinical evaluation plan is a clinical investigation plan.
One device writer speaks of a device's clinical performance rather than its efficacy or effectiveness, terms she associates with drugs, and would have to look up how "effective", if the MDR uses it, differs from clinical performance.
Device documents and their pharmaceutical counterparts
The drug dossier and the device dossier differ greatly in format and content, and knowing the differences helps a writer work effectively. Medical writers need to be aware of the similarities between the regulatory documents for the two as well as the differences.
Writing about devices might seem daunting, because they range from the simplest wound dressing to the most sophisticated imaging equipment, but typical pharmaceutical documents, such as clinical study protocols, clinical overviews and summaries, and summaries of product characteristics, have their equivalents for devices. Device writing is governed by guidelines and directives just as pharmaceutical writing is. Many device documents follow structures similar to those required for pharmaceuticals. The documents submitted for certification of a high-risk device mirror the requirements for approval of new medicines: from articles about in vitro and animal studies to clinical investigation plans and reports, writers work with familiar types of documents and with templates similar to those in pharmaceuticals. Some documents are specific to devices, and for one writer the main one is the clinical expert report.
The regulatory environments for the early stages of drug trials and device investigations are similar, but the differences become more pronounced at the point of entry to the market. The clinical study protocol corresponds to the clinical investigation plan. The clinical investigation plan focuses on safety not only for patients but also for users. Informed consent follows the same principles for devices as for pharmaceuticals, the Declaration of Helsinki among them. Device investigations, like drug trials, require an investigator's brochure. The clinical study report, written to CORE, ICH E3 or both, corresponds to the clinical investigation report. Publications of device trials generally come from less rigorous designs with a lower level of evidence.
At market access, where a medicine has the modules of the Common Technical Document, a device has its technical documentation. Its parts that might be of particular interest to writers are the clinical evaluation plan, the systematic literature review, the clinical evaluation report, the summary of safety and clinical performance and the instructions for use. Under Article 61 of the MDR the systematic literature review is a procedural step of clinical evaluation, with no comparable methodological requirement for pharmaceuticals. Writers may help write the instructions for use, part of which may resemble a summary of product characteristics.
Regulatory categories and documents in the US and the EU
The product categories were defined as follows in the US and the EU in January 2026.
| Category | US definition | US key sources | EU definition | EU key sources | Examples |
|---|---|---|---|---|---|
| Small molecules | Chemically synthesised, low-molecular-weight drugs that exert their primary intended action by pharmacological mechanisms, typically regulated through new drug applications | New drug application | Chemically synthesised medicinal products that exert their primary intended action by pharmacological mechanisms, typically authorised by centralised, decentralised or national procedures | Directive 2001/83/EC | Atorvastatin, imatinib, aspirin, oseltamivir |
| Biologics | Medicinal products derived from living sources such as microorganisms, plant cells or animal cells, regulated through the biologics licence application | Biologics licence application process | Biological medicines produced by or extracted from living systems such as microorganisms, plant cells or animal cells, generally regulated by the centralised procedure | Biological guidelines | Monoclonal antibodies, insulin analogues, vaccines, recombinant proteins |
| Advanced therapy medicinal products | Not a formal FDA category name, but gene therapy, cellular therapy and tissue engineering products are regulated as biologics or as human cells, tissues, and cellular and tissue-based products, through the biologics licence application | Cellular and gene therapy guidances | A subset of biologics based on genes, cells or tissue engineering, categorised as gene therapy, somatic cell therapy or tissue-engineered products, which may be combined with devices, regulated by the centralised procedure | Regulation (EC) 1394/2007; guidelines on advanced therapy medicinal products | CAR-T therapies, adeno-associated virus gene therapies, tissue-engineered skin substitutes, advanced therapies combined with devices |
| Medical devices | Instruments, apparatus, implants, software and the like, intended for diagnosis, treatment or mitigation of disease, that achieve their primary intended purposes without pharmacological, immunological or metabolic action; classes I to III | 21 CFR Part 800 | Any instrument, apparatus, software, implant or the like intended for medical purposes whose principal action is not pharmacological, immunological or metabolic; classes I, IIa, IIb and III | MDR 2017/745; Medical Device Coordination Group guidance | Pacemakers, hip prostheses, surgical instruments, infusion pumps |
| In vitro diagnostics | Devices and related systems for tests on specimens from the human body, performed outside the body to provide diagnostic information; a subset of medical devices | FDA overview of in vitro diagnostic regulation; 21 CFR Part 809 | Devices, reagents or software intended to examine specimens from the human body to provide information for diagnosis, screening or monitoring; classes A to D | IVDR 2017/746; Medical Device Coordination Group guidance | COVID-19 tests, glucose meters and strips, HIV assays |
| Digital health technologies | Software and connected tools, such as software as a medical device, mobile medical apps and clinical decision support, that support healthcare, measurement or behaviour change | Software as a medical device guidance | Digital health, including medical device software and health IT, where intended for medical purposes | MDR 2017/745 and IVDR 2017/746; Medical Device Coordination Group guidance | AI radiology software, wearable devices and apps, remote monitoring platforms |
In 2026, pharmaceutical and device writing differed as follows in clinical studies, marketing authorisation, and safety and post-market surveillance.
| Category | Pharma | Medtech |
|---|---|---|
| Foundational legislation and guidance for clinical studies | US: 21 CFR sections. EU: the Clinical Trials Regulation. US and EU: ICH E6 | US: 21 CFR sections. EU: the MDR for devices, the IVDR for in vitro diagnostics. US and EU: ISO 14155 for devices, ISO 20916 for in vitro diagnostics |
| Study terminology | US and EU: clinical trial | US: clinical investigation for devices; analytical validation or verification for in vitro diagnostics. EU: clinical investigation for devices; performance study for in vitro diagnostics |
| Study endpoints | US and EU: efficacy and safety | US: effectiveness and safety for devices; analytical and clinical performance for in vitro diagnostics. EU: clinical performance and safety for devices; analytical performance, precision, specificity and sensitivity for in vitro diagnostics |
| Study applications | US: investigational new drug application. EU: clinical trial application | US: investigational device exemption. EU: clinical investigation application for devices; performance study application for in vitro diagnostics |
| Key medical writing documents for clinical studies | US and EU: clinical trial protocol, investigator's brochure, clinical trial report, informed consent form | US and EU: clinical investigation plan, investigator's brochure, clinical investigation report, informed consent form |
| Study registration | US: clinicaltrials.gov. EU: the Clinical Trials Information System | US: clinicaltrials.gov. EU: Eudamed, in progress |
| Primary regulatory pathways | US: new drug application for small molecules, biologics licence application for biologics. EU: marketing authorisation application by centralised, decentralised or mutual recognition procedures | US: 510(k), de novo, premarket approval. EU: CE marking by conformity assessment under the MDR or IVDR |
| Foundational legislation for marketing authorisation | US: 21 CFR Part 314. EU: Regulation (EC) No 726/2004; Directive 2001/83/EC | US: 21 CFR 800 for devices; 21 CFR Part 809 for in vitro diagnostics. EU: the MDR and the IVDR |
| Regulatory authorities and conformity bodies | US: FDA CDER for new drug applications, FDA CBER for biologics licence applications. EU: the EMA's CHMP for the centralised procedure; national competent authorities for the decentralised procedure | US: FDA CDRH. EU: notified bodies, for conformity assessment |
| Core application structure | US and EU: the Common Technical Document according to ICH M4 | US: submissions tailored to 510(k), de novo or premarket approval, with the eSTAR template for 510(k) and de novo. EU: technical documentation with no standard structure |
| Key medical writing documents before and at registration | US and EU: the CTD clinical modules — clinical overview (2.5), clinical summaries (2.7), study reports (5) | US: no specific documents; submissions tailored to the pathway; the eSTAR template. EU: clinical evaluation plan and report under MEDDEV 2.7/1 revision 4 and ISO 18969, in progress, for devices; performance evaluation plan and report for in vitro diagnostics |
| Post-market requirements | US: postmarketing requirements. EU: post-approval safety studies | US: post-market surveillance. EU: post-market surveillance; post-market clinical follow-up for devices; post-market performance follow-up for in vitro diagnostics; summary of safety and clinical performance |
| Safety reporting in development and after approval | US: annual safety report. EU: development safety update report; periodic benefit-risk evaluation report | US: electronic medical device safety reporting. EU: vigilance and post-market surveillance through Eudamed, in progress |
The technical differences
One experienced device writer stresses that writing about devices requires not only a comprehensive knowledge of human anatomy but also an understanding of the physics and engineering behind the product's functionality. Because a device's primary mode of action is not pharmacological, one writer who moved from pharmaceuticals to devices looks at device performance, also called effectiveness. Writing for devices includes assessing device performance outcomes, which depend on the experience of the operator and the team and on the setting: evaluating learning curves and quality variations, for example, and alleviating problems of equipoise, the genuine uncertainty that the treatment is beneficial.
For the writer who moved from pharmaceuticals to devices, the technical aspect was the overriding difference. At first the main differences for her were working with departments she had not worked with in pharmaceuticals, in her case software or mechanical engineering, and human factors, the usability of the device and its use errors, which had to be factored into the writing. Equipoise was a new concept to her, met while working with a robotically assisted surgical device. Her device writing also involved determining whether a problem reflected a deficient device or an operator error. In 2019 she still had to look into transparency: the guidance for pharmaceuticals was clear to her, but what the MDR says about disclosure was not.