Regulatory Writing for Medical Devices

Medical communicators who work in the pharmaceutical space will recognize some features of medical device writing.

Regulatory writers for drugs and devices are a part of the effort to bring safe, effective medical products to the public. Therefore, writers in both specialties need to be familiar with a field that is changing as fast as the technology itself.

As the regulatory environment evolves (especially in the EU with MDR 2017/745), the field needs skilled writers who can navigate the complex medical device landscape.

Medical device writing provides an opportunity for professional medical writers to expand their skill set. 

What are the features of the regulatory environment for devices? What are the differences between regulatory writing for pharmaceuticals and regulatory writing for medical devices? 

What Is a Medical Device?

Medical devices are products that do not involve a chemical process in the body— everything from in vitro diagnostics to bedpans. In the US, the Food and Drug Administration (FDA) regulates medical devices and provides guidance on what is and isn’t a medical device. 

The Food, Drug, and Cosmetic Act provides the legal basis for regulating medical devices in the United States. Section 201(h)(1) defines a medical device as follows:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

• (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

Considerations for Medical Device Writing

The key differences between pharmaceuticals and medical devices that medical writers need to be aware of are the regulatory requirements related to the nature of the products, the complexity of testing the products, the level of innovation involved in pharmaceuticals, the approval pathways, and the regulatory focus. 

1. The nature of the products. Pharmaceuticals are chemically active, interacting with biological processes. The potential for adverse reactions is high. Medical devices often have mechanical or supportive roles, with a more localized risk profile. 

2. Testing complexity. Pharmaceuticals require complex preclinical and clinical trials to understand efficacy, dosing, pharmacokinetics, and pharmacodynamics. Some devices, depending on their classification, may require less intensive testing. The exception is Class III devices (life-supporting or life-sustaining devices).

3. Innovativeness and evolution. As novel chemical entities, pharmaceuticals require comprehensive study to fully understand their impact. Many medical devices are iterative, which allows for leveraging existing data, streamlining the approval process.

4. Approval pathways. Pharmaceuticals follow a linear process through discovery, preclinical, and clinical trials (1-3), and then review. Devices have different pathways such as 510 (k) for demonstrating substantial equivalence to existing devices or the more rigorous Premarket Approval (PMA) for high-risk devices.

5. Regulatory focus. All drugs require clinical trials, but not every medical device requires one. Again, this depends on the level of risk the device poses. In the US, all Class III and some Class II Devices require clinical trials. For medical devices, it may be unethical or impossible to use a placebo or double-blind protocols. For example, a subject would not undergo a sham knee replacement, as it would require withholding treatment. 

6. Differences in safety reporting requirements. The safety reporting requirements for devices differ from those for drugs. For drugs, sponsors are only required to report serious adverse events (SAEs) that may reasonably be regarded as caused by, or likely caused by, the drug. For devices, manufacturers are required to report all SAEs, even if they are not directly related to the device or the procedure in which the device is used. This requirement applies not just to implantables, but also to in vitro devices and diagnostics that are not used directly by the patient. If a participant in an in vitro diagnostic trial experiences a health condition that is not related to the device, that condition must still be reported.

7. Differences in terminology. Clinical study types for devices are often called preclinical, Pilot, Pivotal, and post-approval.

Regulatory Writer Responsibilities

An article by Roderick Mallia and Beate Walter in the journal Medical Writing explores the similarities and differences between these two regulatory writing specialties. “There has been a recent move to adopt more stringent regulatory requirements for the medical device industry, bringing the environment closer to what we have come to expect from the highly regulated pharmaceutical industry,” the authors write. As the article makes clear, the two regulatory environments share similarities. 

The responsibility of regulatory writers is to

• Communicate the science clearly

• Accurately document the balance of safety, performance, and benefits

• Help medical device  manufacturers fulfill regulatory requirements

Growth Opportunity

As the regulatory requirements for medical devices coalesce and evolve, medical device manufacturers face increasing documentation requirements. That means more opportunities for writers who are familiar with the required documents.

Writers who grasp the intricacies of medical device writing will be in high demand, and regulatory medical communicators with pharmaceutical experience already have many of the skills needed to bridge the two specialties.

AMWA acknowledges the contributions and peer review from Madison Hedrick, MA in the development of this AMWA resource.