MEDICAL WRITING SERVICES PROVEN TO ACCELERATE COMMERCIALIZATION OBJECTIVES

Clinical Evaluation Reports (CERs) / Performance Evaluation Reports (PERs) are vital technical documents required for market approval of medical devices and In Vitro Diagnostics (IVDs) within a variety of markets. Clinical evaluation is a structured and ongoing process, involving collection, appraisal and analysis of clinical data relating to the device. The purpose is to demonstrate compliance with specific safety and performance requirements as related to its intended purpose. This process involves the evaluation of the clinical benefit-risk profile for the device using the latest available clinical data, e.g., derived from clinical studies, published literature, and active post-market surveillance.

The Clinical Evaluation Plan (CEP) / Performance Evaluation Plan (PEP) describes the scope, methodology and systematic approach to employ within the evaluation. While the CER/PER provides a detailed description of the actual conduct of the clinical evaluation, information analyzed and conclusion(s) reached. Both documents require regular updating throughout the life cycle of the medical device and are subject to review and scrutiny by the regulatory authorities.

NAMSA’s team of CER/PER medical writing experts is highly qualified and skilled, producing approximately 200 CERs/PERs annually in compliance with market-specific requirements. Collaborating with NAMSA’s Regulatory Team, who have worked for various Notified Bodies, our medical writers are equipped with in-depth knowledge of regulatory requirements and guidelines specific to varying global regions and have extensive experience supporting clients with CER/PER submissions.

Together, we ensure the correct match of skills and expertise required to organize, interpret and present data accurately, efficiently and professionally that is highly recognized and trusted by global regulatory entities. We take particular pride in our reputation for speed of delivery, the quality of our reports and our outstanding record for approvals. NAMSA consistently receives positive feedback on our medical writing services from clients and major Notified Bodies, resulting in hundreds of clients passing the approval process without issue.

NAMSA provides CERs/PERs and CEPs/PEPs covering all device classes and therapeutic areas, including combination products. Clinical and Performance Evaluation services offered by NAMSA include:

• Ad-Hoc Medical Writing support
• Medical Writing of plans and reports
• Maintenance or regular updates of plans and reports
• Bundled plans and reports, covering multiple product variants
• Clinical and Performance Evaluation guidance, training and SOP writing/updating
• Gap analyses per international guidance
• Systemic literature review
• Physician or peer review

Compliance with evolving legal labeling requirements is essential in all countries in which a medical device is distributed. Errors and inaccuracies in labeling and Instructions for Use (IFUs) may threaten patient safety and result in damaging recalls and fines.

Within the United States, the Food and Drug Administration (FDA) administers the Global Unique Device Identification Database (GUDID) and stipulates that from 24 September 2020, all devices—including Class I and unclassified medical devices—must have appropriate UDI labeling. This must include brand name, description, catalog number, handling instructions, expiration date and other pertinent information. NAMSA supports manufacturers in labeling needs by managing UDI exception requests and reviewing labeling and instruction requirements to ensure that all remaining portfolio products are compliant.

A similar, although crucially different, system will operate within the European Union with the rollout of a European Database on Medical Devices (EUDAMED), together with the introduction of European Medical Device Regulation (MDR) EU 2017/745. This will present significant challenges for many manufacturers, as although labeling requirements have been well defined under MDD, with harmonized standards and guidance documents available to aid interpretation, the MDR requirements described in the GSPRs (Annex I) are more complex and descriptive. They include a large number of new elements, especially for implantable and sterile devices, and currently there are no harmonized standards available to help navigate these requirements. Also new in the MDR is the “General requirements regarding the information supplied by the manufacturer” (SPR 23.1), indicating a new format for the presentation user information, more specifically; eLabeling as described in (EU) No 207/2012 on electronic IFUs for medical devices.

NAMSA’s multidisciplinary, cross-functional medical writing service teams understand the criticality of ensuring accuracy, completeness and ergonomic usability of information contained within medical device labels, IFUs and user instruction manuals. Working together, our regulatory and medical writing experts have extensive industry experience to help you design and review these materials to ensure compliance to applicable global regulatory requirements.

The European Medical Device Regulation (MDR) EU 2017/745 requires the preparation of Post-Market Surveillance Reports (PMSR) or Periodic Safety Update Reports (PSUR); (Chapter VII, Article 86), depending on device classification. A PMSR is intended for low-risk class I devices, while a PSUR is intended for moderate and high-risk devices (class IIa, IIb, III, implantable). Irrespective of whether a medical device has a valid certificate under the Medical Device Directive (MDD) 93/42/EEC or MDR, all manufacturers must comply with Post-Market Surveillance requirements outlined in the MDR after the date of application of 26 May 2021.

NAMSA’s highly experienced medical writing team, together with our Clinical and Regulatory experts, support manufacturers in the production and submission of both PMSRs and PSURs. (See Table 1 below)

Table 1: PMSRs and PSURs—Overview of Reporting Requirements by Risk Category

With regular and frequent shifts in global regulatory requirements, reimbursement policies and user requirements, it is becoming increasingly important for manufacturers to demonstrate transparency. Also critical is ensuring that results obtained from Post-Market Surveillance activities and clinical studies are made publicly accessible and adequately described in clinical and scientific literature.

Publishing scientific articles in relevant medical journals and presenting clinical findings at conferences is beneficial for manufacturers. Scientific dissemination of pertinent information helps strengthen awareness and recognition of a product, together with the overall reputation of the manufacturer, among relevant clinical audiences. These activities may support a manufacturer’s marketing efforts and yield direct commercial benefits in terms of sales, especially when the results are favorable. However, even limited data and inconclusive findings, placed in the public domain, may positively influence third-party decisions relating to market access, reimbursement and clinical guidelines when combined with other available data (e.g., in the form of meta-analyses or health economic evaluations).

With solid industry experience and extensive scientific and academic training, NAMSA’s medical writing services can help your business take charge of its global presence and scientific assets. Even if you have not taken the opportunity to involve NAMSA in conducting your clinical research, our medical writers are available and ready to support you in disseminating clinical data regarding your products by preparing ready-to-submit scientific publications and conference abstracts. To achieve this, our medical writers will partner with your organization and study investigators, in addition to NAMSA’s Biostatistics Team (if required) to translate clinical findings into relevant, publishable scientific literature that will support your commercial objectives.

NAMSA’s professional medical writing services include a variety of evidence communication outputs, including:

• Advisory panel presentations
• Conference abstracts, presentations and posters
• Health economic evaluations
• Professional education materials (e.g. clinical summaries)
• Scientific publications, including journal articles (e.g. study protocols, case studies, PMCF studies, clinical trials, etc.)
• Systematic reviews and meta-analyses
• White papers and other manuscripts

The European Medical Device Regulation (MDR) EU 2017/745 requires that manufacturers of implantable and class III devices (other than custom-made or investigational devices) must create a Summary of Safety and Clinical Performance (SSCP). The SSCP document is intended to provide public access to an updated summary of clinical data and other information about a medical device’s safety and clinical performance for healthcare professionals and, if relevant, patients.

This obligation is in addition to the requirement for creating a Periodic Safety Update Report (PSUR). All manufacturers must comply with Post-Market Surveillance (PMS) requirements detailed in the MDR after the date of application on 26 May 2021, irrespective of whether a medical device has a valid certificate under the Medical Device Directive (MDD) 93/42/EEC or MDR.

NAMSA’s experts have carefully analyzed the requirements and recommendations of the MDR and associated guidance documents to help guide clients through this early period of enforcement with ease and confidence. Working closely with our EU Regulatory Team, NAMSA’s medical writers have the expertise and knowledge to create SSCPs tailored towards intended users/healthcare professionals and patient/lay audiences in compliance with these regulatory requirements.

A clinical study protocol is a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. Ensuring the quality, validity and ethical conduct of a study involving human subjects is essential. A well-written protocol can ease the approval process by regulatory authorities, ethics committees, and funding agencies, ultimately ensuring the study is conducted as intended, avoiding costly delays and protocol amendments.

NAMSA offers a comprehensive service for developing clinical study protocols. Our experienced medical writers work closely with our clinical, regulatory and biostatistical experts to create protocols tailored to your specific device, indication and target market. We can help you define the study objectives, endpoints, sample size, inclusion and exclusion criteria, randomization and blinding procedures, data collection and analysis methods, safety monitoring and reporting requirements and any other aspects of your trial. We can also assist you with preparing informed consent forms, case report forms, investigator brochures and other study-related documents.

Whether you need a feasibility study, a pilot study, a pivotal trial, or a post-market surveillance study, NAMSA can help you design and execute a clinical study protocol that meets your regulatory and business needs.

Clinical Study Reports (CSRs) are comprehensive documents that summarize the methods, results, and conclusions of a clinical trial. CSRs are essential for regulatory submissions, publications, and marketing activities. They provide the evidence to demonstrate the safety and effectiveness of a medical device in a specific patient population and clinical setting.

A well-written CSR can help speed up the approval process and the market acceptance of a medical device. A poorly written CSR can lead to delays, rejections, or unfavorable reviews. Therefore, qualified medical writers who understand the regulatory requirements, international standards, and the industry best practices, which will help raise the bar of your report development.

NAMSA offers a full range of clinical medical writing services, from protocol development to final report writing. Our medical writers have extensive knowledge and expertise in various therapeutic areas, device types, and study designs. They work closely with our biostatisticians, clinical operations team, and safety team to ensure the accuracy, consistency, and quality of the CSRs. Whether you need a CSR for a pilot study, a pivotal trial, or a post-market surveillance study, NAMSA can deliver it on time and within budget.