NAMSA provides a wide range of specialized report writing, manuscript submission and evidence communication services. Our world-class medical writing team is experts at identifying, organizing, interpreting and presenting clinical data in an accurate and professional manner that is highly recognized and trusted by medical device manufacturers and global regulatory entities. The team is also experienced and skilled in defining and prioritizing which reports are required to comply with the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), MEDDEV 2.7.1 rev. 4, NMPA regulations and a multitude of other regulatory guidelines.
NAMSA’s global team is comprised of more than 30 fully dedicated medical writers from a diverse range of clinical and scientific backgrounds of whom one-third hold doctorates; many have also spent a portion of their careers at leading Notified Bodies. All experts are native or fluent English speakers; other language capabilities include Arabic, French, German, Italian, Japanese, Portuguese, Russian, Spanish and Standard Chinese.
Working in close partnership with NAMSA’s Regulatory, Clinical and Biostatistics Teams, our medical writers are highly responsive to individual needs, and are instrumental in helping clients achieve commercial objectives. When working with NAMSA, clients are also provided a personalized plan to help guide future compliance activities.
Clinical Evaluation Reports & Plans (CERs | CEPs)
Clinical Evaluation Reports (CERs) are vital technical documents required for market approval of medical devices within a variety of markets, most notably Europe, China, and Australia. 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 a market’s specific requirements for safety and performance as related to its intended purpose. This involves 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) describes the scope, methodology and systematic approach to employ within the clinical evaluation. While the CER 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 30+ CER experts are both highly qualified and skilled, producing approximately 200 CERs annually in compliance with market specific requirements. Collaborating with NAMSA’s Regulatory Team, who collectively contribute more than 60 years’ experience working 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 submissions in Europe, China and Australia.
All medical writers are fluent in English, both conversationally and for technical writing purposes. In addition, our international team has wide-ranging language capabilities to support clients from non-English speaking countries who may prefer to communicate in their native language. Together, we ensure the correct match of skills and expertise required to organize, interpret and present data in an efficient, accurate and professional manner 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 CERs. NAMSA consistently receives positive feedback from both clients and major Notified Bodies, resulting in hundreds of clients passing the approval process without issue.
NAMSA provides CERs and CEPs covering all device classes and therapeutic areas, including combination products. CER services offered by NAMSA include:
- Ad-Hoc Medical Writing Support
- Bundled CEP/CERs, where a single CER covers multiple product variants
- CER guidance, training and SOP writing / updating
- Gap analyses and/ or CERs per international guidance, including:
- Australia: CERs for Therapeutic Goods Administration (TGA) approval
- China: CERs for National Medical Products Administration (NMPA) approval
- Medical Writing or Peer Review of CERs
- Maintenance / annual update to CER/CEP per MEDDEV 2.7/1 Rev 4 and MDD or MDR
- Physician or peer review of CERs
- Submission / De Novo CER/CEP for non-CE marked devices per MEDDEV 2.7/1 Rev 4 and EU MDD 93/42/EEC as revised 2007/47/EC or EU MDR 2017/745
- Upgrades to CER/CEP (e.g. from MEDDEV Rev 3 to Rev 4 or MDD to MDR, including MDCG guidance)
Clinical Literature Reviews
Clinical literature reviews can serve as a valuable tool in strengthening a manufacturer’s product portfolio. A thorough search and robust synthesis of available literature relevant to a particular medical device may provide important information to guide further product development, reveal much needed evidence to substantiate current clinical indications, identify potential ‘off-label’ applications or flag critical adverse event (AE) data.
Depending on the scope, such a review might also consider information gathered from pre-clinical studies for regulatory purposes or to provide information of commercial interest in relation to a competitor device. Within the U.S. in particular, both FDA guidance and the Code of Federal Regulations stipulate the need for literature reviews as sources of information regarding safety, efficacy and ‘known use.’
A device manufacturer should be the foremost expert on their particular medical device, and this is where NAMSA can help. Our team of medical writers come from a diverse range of clinical, technical and scientific backgrounds to provide you with the objective answers you need to support your desired commercialization and business outcomes.
Under the rules set by Article 18 of the EU Medical Device Regulation (MDR), manufacturers of implantable devices are required to include an implant card with any device. Health institutions provide the implant cards to patients, which enables them to identify the implanted devices and therefore, receive access to information specific to their device.
Implant cards are also useful in specific situations (e.g. at airport security checks), or in emergencies, allowing clinical staff to respond quickly as they are made aware that the patient needs special care. MDCG 2019-8 v2 provides useful guidance for manufacturers with regard to implant card design, which may be managed in conjunction with product labeling. Additionally, this guidance highlights the responsibility of the manufacturer for providing an accompanying information leaflet and investigating its use among health professionals by means of an ergonomic analysis or ergonomic usability test procedure.
NAMSA can assist you in addressing the requirements of Article 18 of the MDR. Our experts are available to guide you through these regulations, and can help to design and develop content for implant cards and instructions if required. Crucially, NAMSA can also design, conduct and report necessary ergonomic research required to provide evidence needed for risk management purposes.
Labeling, Instructions for Use and User Manuals
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 September 24 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 roll out 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 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.
Periodic Safety Update Reports and Post-Market Surveillance Reports (PSURs | PMSRs)
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. Whereas a PMSR is intended for low-risk class I devices, 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)
|MDR Classification||PSUR | PMSR||Update Frequency|
|Class I||PMSR||When Necessary|
|Class IIa||PSUR||Every 2 Years (min)|
|Class III||PSUR||Annually (min)|
Table 1: PMSRs and PSURs—Overview of Reporting Requirements by Risk Category
Scientific Publications & Conference Abstracts
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 largely beneficial for manufacturers. Scientific dissemination of relevant 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 exercise a positive influence on third party decisions relating to market access, reimbursement and clinical guidelines when combined with other available data (e.g. in the form of a meta-analyses or health economic evaluations).
With solid industry experience and extensive scientific and academic training, NAMSA’s medical writers 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 medical writing solutions 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
Summaries of Safety & Clinical Performance (SSCPs)
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 the safety and clinical performance of a medical device for healthcare professionals and, if relevant, patients.
This obligation is in addition to the requirement for the creation of 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 in order to help guide clients through this early period of enforcement with ease and confidence. Working closely with our 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 particular regulatory requirements.