Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices.
It encompasses single-use plastic items outlined in the Annex and products made from oxo-degradable plastic and plastic-containing fishing gear.
Member States are mandated to implement measures to significantly reduce the consumption of single-use plastic products listed in Part A of the Annex, aligning with the broader goals of the EU’s waste management policy, notably waste prevention.
What is the Directive 2019/904?
Adopted in June 2019, this directive aims to reduce the environmental impact of certain plastic products, particularly single-use plastics (SUPs). SUPs are defined as any plastic item designed for single use and not intended to be reused.
Due to its versatile functionality and cost-effectiveness, plastic has become increasingly pervasive in various aspects of daily life.
While it serves crucial roles in many industries, its extensive use in disposable applications, which are often not designed for reuse or efficient recycling, has led to inefficient and linear production and consumption patterns.
Recognizing this challenge within the Circular Economy Action Plan outlined in the Commission’s communication of December 2, 2015, titled ‘Closing the Loop – An EU Action Plan for the Circular Economy,’ the Commission emphasized in its European Strategy for Plastics, articulated in the communication of January 16, 2018, titled ‘A European Strategy for Plastics in a Circular Economy,’ the urgent need to address the escalating generation of plastic waste and its leakage into the environment, notably marine ecosystems.
This strategy aims to transition towards a circular economy where plastic design and production prioritize reuse, repair, and recycling while promoting the development and adoption of more sustainable materials.
Given the significant adverse environmental, health, and economic impacts of certain plastic products, establishing a specific legal framework is deemed necessary to mitigate these negative effects effectively.
The objective of this directive is to prevent and reduce the impact of certain plastic products on the environment, in particular the aquatic environment, and on human health, as well as to promote the transition to a circular economy with innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market.
This Directive applies to the single-use plastic products listed in the Annex, to products made from oxo-degradable plastic and to fishing gear containing plastic.
What is Directive 2019/904?
Under this Directive, ‘plastic’ means a material consisting of a polymer as defined in point 5 of Article 3 of Regulation (EC) No 1907/2006, to which additives or other substances may have been added and which can function as a primary structural component of final products, with the exception of natural polymers that have not been chemically modified.
‘Single-use plastic product’ means a product made wholly or partly from plastic and that is not conceived, designed, or placed on the market to accomplish multiple trips or rotations within its life span by being returned to a producer for refill or re-used for the same purpose for which it was conceived.
How does Directive 2019/904 impact medical devices and cosmetics?
The Single-Use Plastics (EU Directive 2019/904) has a minimal direct impact on most medical devices and cosmetics. This is because the directive targets a specific list of single-use plastic items, and most medical devices and cosmetics do not use single-use plastics for packaging.
Medical devices and cosmetics have their own separate regulations (EU 2017/745 and EC No 1223/2009, respectively) that address packaging safety and materials.
However, there’s an indirect influence on medical devices and cosmetics, which ensures a Sustainability Push. The SUP Directive promotes a general shift towards reducing plastic use. This can indirectly pressure manufacturers of medical devices and cosmetics to:
Minimize Plastic Packaging: They might explore alternative packaging materials or reduce plastic use.
Use Recycled Plastic: Manufacturers could utilize recycled plastic content in their packaging to comply with the spirit of the directive.
Overall, SUPs might be used in medical devices and cosmetic packaging, but the SUP Directive doesn’t directly regulate them. It creates a broader push for sustainable practices that can indirectly influence packaging choices in these industries.
The CE marking signifies a medical device’s adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By mandating rigorous assessments, it directly impacts patient safety.
Manufacturers must demonstrate their devices meet essential safety and performance requirements, minimizing risks associated with malfunction, biocompatibility issues, or inadequate design. Ultimately, CE marking is a vital assurance for patients and healthcare professionals, fostering trust in the medical devices used for diagnosis, treatment, and care.
This article discusses why CE marking of device devices is of paramount importance.
How does CE Marking Compliance Impact Patient Safety?
CE marking compliance for patient safety mandates a rigorous assessment process for medical devices. Manufacturers must demonstrate that their products meet essential safety and performance requirements.
This translates to real-world benefits for patients:
Minimized Risk: CE marking compels manufacturers to identify and mitigate potential risks associated with their devices. This includes evaluating factors like malfunction, biocompatibility (compatibility with human tissue), and design flaws, addressing these concerns and thereby reducing the risk of adverse events for patients.
Enhanced Performance: The CE marking process ensures that devices perform as intended. This translates to accurate diagnoses, effective treatment delivery, and improved patient outcomes. For example, a CE-marked thermometer can be trusted to provide precise temperature readings, which is crucial for proper diagnosis and treatment decisions.
Transparency and Accountability: CE marking fosters transparency by holding manufacturers accountable for the safety and quality of their devices. Patients and healthcare professionals can be confident that CE-marked devices have undergone rigorous evaluation. The CE marking process also requires maintaining a technical file with detailed device information, allowing for traceability and facilitating potential post-market safety monitoring.
CE marking journey: A step-by-step approach to CE mark
The Conformité Européenne or CE mark means that the manufacturer takes responsibility for a product’s compliance with all applicable European health, safety, performance and environmental requirements. The road to CE marking compliance for patient safety is a multi-step process.
Here’s a breakdown of the critical stages:
Classification: Manufacturers first classify their device based on its intended use and potential risks. This determines the level of scrutiny required during the assessment process.
Technical Documentation: A comprehensive technical file is compiled detailing the device’s design, manufacturing processes, risk assessments, and performance testing data. This file is a vital record for regulators and facilitates future vigilance activities.
Conformity Assessment: Depending on the classification, the manufacturer may need to undergo an independent assessment by a notified body – an organization recognized by the EU to evaluate medical devices. This assessment verifies the technical documentation and may involve inspections of manufacturing facilities and testing the device itself.
Declaration of Conformity: Once satisfied with the device’s safety and performance, the manufacturer formally declares that the device meets all relevant CE marking compliance requirements.
Device Marketing and Post-Market Surveillance: Following CE marking, the device can be placed on the market. However, the manufacturer’s responsibility continues. Post-market surveillance ensures the device’s continued safety and effectiveness in real-world use. This involves collecting and analysing feedback from healthcare professionals and patients, monitoring for adverse events, and implementing corrective actions.
Figure: Steps involved in CE marking of a medical device
Conclusion
The CE marking signifies more than just regulatory compliance within the European Union (EU); it is a cornerstone of patient safety for medical devices. The stringent procedures mandate a rigorous assessment and adherence to well-defined safety principles.
CE marking fosters trust in the medical device market, empowering patients to receive high-quality healthcare with minimized risks.
Ultimately, it serves as a robust system that safeguards patient well-being while promoting innovation in developing safe and effective medical technologies.
As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements.
Top 7 Key Strategies for optimizing Post-Market Surveillance
Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR standards.
1. Early Integration of Post-Market Surveillance into Quality Management
Integrate post-market surveillance activities into your quality management system (QMS) from the outset of product development. By incorporating PMS processes early, you establish a solid foundation for ongoing monitoring and compliance with EU MDR requirements.
This proactive approach mitigates risks and facilitates timely identification and resolution of issues in the post-market phase.
Establish comprehensive post-market monitoring protocols to systematically collect, analyze, and respond to data related to device performance, adverse events, and customer feedback.
Regularly review and update these protocols to align with evolving regulatory guidelines and industry best practices. By conducting thorough post-market monitoring, you demonstrate a commitment to patient safety and regulatory compliance.
3. Leverage Purpose-Built Tools for PMS
Utilize specialized software solutions designed for medical device surveillance and post-market monitoring. These tools offer features such as complaint handling, nonconformance management, and CAPA processes tailored to EU MDR requirements.
By leveraging purpose-built tools, you streamline PMS workflows, enhance data accuracy, and ensure compliance with regulatory standards.
4. Foster Cross-Functional Collaboration
Promote cross-functional collaboration and communication across departments involved in post-market surveillance, including regulatory affairs, quality assurance, and product development.
Establish clear channels for reporting and escalating issues, facilitating timely decision-making and corrective actions. By fostering a collaborative culture, you enhance transparency and accountability in PMS activities.
5. Ensure Compliance with Post-Market Requirements
Stay informed and up-to-date on the latest post-market requirements outlined in EU MDR legislation. Regularly review guidance documents and regulatory updates issued by competent authorities to ensure compliance with reporting obligations, vigilance requirements, and post-market clinical follow-up (PMCF) obligations.
By maintaining compliance with post-market requirements, you mitigate regulatory risks and uphold patient safety standards.
6. Enhance Data Traceability and Documentation
Maintain comprehensive traceability of post-market surveillance activities through robust documentation and data management practices. Implement systems for documenting complaints, adverse events, corrective actions, and other PMS-related information in accordance with EU MDR documentation requirements.
By enhancing data traceability, you facilitate regulatory inspections and demonstrate compliance with post-market obligations.
7. Embrace Continuous Improvement
Embrace a culture of continuous improvement in post-market surveillance processes, leveraging data-driven insights to drive enhancements and optimizations.
Regularly assess the effectiveness of PMS activities, identify areas for improvement, and implement corrective measures as needed. By prioritizing continuous improvement, you demonstrate a commitment to excellence in post-market surveillance and patient safety.
In conclusion, staying vigilant in post-market surveillance under EU MDR requires proactive planning, robust monitoring protocols, and a commitment to compliance with regulatory requirements.
By integrating PMS into quality management systems, leveraging purpose-built tools, fostering cross-functional collaboration, and embracing continuous improvement, medical device manufacturers can navigate the complexities of post-market surveillance with confidence and ensure ongoing regulatory compliance.
A Quality Management System is defined by ISO 13485 as a set of processes, procedures, and responsibilities for achieving quality policies and objectives in a medical device manufacturing organisation. It is a structured system that ensures that medical devices consistently meet customer and regulatory requirements.
ISO 13485 is an international standard that specifies requirements for a QMS specific to the medical device industry. ISO 13485 is a stand-alone QMS standard based on ISO 9001:2008, superseded by ISO 9001:2015.
It covers the design, development, production, storage, distribution, installation, servicing, and final decommissioning of medical devices.
Implementing a QMS based on ISO 13485 helps organisations demonstrate their ability to provide medical devices and related services that meet customer expectations and regulatory requirements, fostering customer confidence and regulatory compliance.
One of the critical advantages of ISO 13485 is that it ensures a strong starting point if a manufacturer wants to certify their products under the EU Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR).
MDR requirements for QMS
EU MDR states the requirement for a well-established and maintained QMS in Article 10 (9).
Article 10 of the Medical Device Regulation (MDR) outlines a set of criteria governing Quality Management Systems (QMS) for Manufacturers operating in the medical device sector.
This article mandates that manufacturers establish, document, implement, maintain, update, and enhance a QMS that aligns with MDR specifications. Furthermore, it stipulates that the QMS must be aligned with the risk classification, the nature of the device and the business.
Article 10 specifies several fundamental aspects that the QMS must address at a minimum, which are as follows:
A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.
Identification of applicable general safety and performance requirements and exploration of options to address those requirements.
Responsibility of the management.
Resource management, including selection and control of suppliers and sub-contractors.
Risk management is set out in Section 3 of Annex I.
clinical evaluation by Article 61 and Annex XIV, including PMCF.
Product realisation, including planning, design, development, production, and service provision.
Verify the UDI assignments made by Article 27(3) to all relevant devices and ensure the consistency and validity of the information provided by Article 29.
Setting up, implementing and maintaining a post-market surveillance system in accordance with Article 83.
Handling communication with competent authorities, notified bodies, other economic operators, customers and other stakeholders.
Processes for reporting serious incidents and field safety corrective actions in the context of vigilance.
Management of corrective and preventive actions and verification of their effectiveness.
Processes for monitoring and measurement of output, data analysis and product improvement.
This list of minimum requirements highlights that the Quality Management System necessitates a documented procedure for all significant activities directly associated with individual medical devices, along with broader processes about the company’s overall operations.
The EU MDR does not impose specific requirements for a QMS. However, manufacturers are responsible for implementing appropriate content tailored to the risk class and organisational nature.
How do you implement a QMS that actually works?
Manufacturers can utilise harmonised standards, such as ISO, to aid in implementing MDR requirements. Compliance with recognised harmonised standards, like ISO 13485:2016 for Quality Management Systems, establishes a presumption of conformity with relevant aspects of the MDR.
ISO 13485 provides detailed provisions for developing QMSs that align with most MDR quality management requirements.
Manufacturers must, therefore, ensure that a system compliant with both ISO standards and the MDR requirements outlined in Article 10 is in place to address the comprehensive demands of quality management in the medical device industry.
A manufacturer’s quality management system will be assessed as part of the conformity assessment procedures outlined in MDR Annex IX to XI. Conformity assessment for Class Ir, Is, a Notified Body will carry out Im, IIa, IIb and III devices.
Formal evaluation and certification by a notified body are not conducted for Class I devices, but the QMS requirements still apply.
Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies.
Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regulatory requisites for the specific market.
Difficulties in evaluating and classifying products can arise even within the EU’s legal framework. For instance, within the EU Cosmetic Regulation 1223/2009, a mouthwash claiming “antibacterial” or “antiseptic” properties could fit into various categories: cosmetics, biocidal products, or medicinal products.
Additionally, if the product involves a device, like implants, it might be categorized as a medical device. The EC makes decisions regarding the classification of these “borderline products” on a case-by-case basis.
Definition of a Cosmetic product
A cosmetic product, as defined by the EU Cosmetic Regulation, shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body or with the teeth and mucous membranes of the oral cavity for the purposes of cleaning them, perfuming them, changing their appearance, correcting body odours, and protecting them or keeping them in good condition.
The purpose/function, formulation, and application site must be clearly defined to classify a cosmetic product under the EU Cosmetic Regulation.
EU Cosmetic Regulation Functions
Cosmetic products serve primary purposes such as altering appearance (as in makeup), cleansing, enhancing beauty, imparting fragrance, safeguarding, or rectifying odors.
Additionally, these products can possess secondary functions, like biocidal or antimicrobial effects in oral hygiene items or deodorants primarily intended for cosmetic use.
When assessing a cosmetic’s function, crucial considerations encompass the manufacturer’s intent, presentation, labelling, advertising, claims, mode of action, composition, and how consumers perceive it. With a clearly defined primary function, a cosmetic product can avoid falling into a different product category.
Formulation
The composition of a cosmetic product strongly determines its function. Claims often rely on specific ingredients used in the product’s formulation, such as those linked to therapeutic use (like fluoride in toothpaste).
To meet standards, a cosmetic’s formulation should avoid prohibited ingredients listed in Annex II of the EU Cosmetic Regulation, adhere to restrictions in Annex III, and comply with guidelines for colorants (Annex IV), preservatives (Annex V), and ultraviolet (UV) filters (Annex VI).
EU Cosmetic Regulation Application Site
Cosmetic products are designed to be applied to the outer surfaces of the human body, including the epidermis, hair, nails, lips, external genital organs, as well as the teeth and mucous membranes within the oral cavity.
Definition of biocidal product
A biocidal product contains an active substance to eradicate, deter, neutralise, or control harmful or unwanted organisms. The primary function indicated by its claims plays a pivotal role in distinguishing between a cosmetic and a biocidal product.
For instance, bath soaps boasting antibacterial or antiseptic properties fall under biocidal products, as do sunscreens with their UV protection abilities.
Definition of the medicinal product
As per Directive 2001/83/EC, a medicinal product is any substance or blend possessing therapeutic or preventive properties in humans. This encompasses substances administered to restore, correct, or alter physiological functions through pharmacological, immunological, or metabolic actions, or for medical diagnosis.
For instance, shampoo is labeled a cosmetic product as its primary purpose is hair cleansing. Conversely, an anti-dandruff treatment is classified as a drug due to its intended use for dandruff treatment via pharmacological action.
Therefore, an anti-dandruff shampoo holds both cosmetic and drug classifications.
Definition of a Medical Device
According to European Union Regulation (EU) 2017/745, a medical device refers to any instrument, apparatus, equipment, software, implant, reagent, material, or another article, used alone or in combination.
In short, a medical device is intended for use in human beings for a disease, injury or disability, an anatomical structure or function, a physiological or pathological process, as well as other special medical cases.
Furthermore, this regulation encompasses specific products intended for aesthetic purposes, such as colored contact lenses, devices emitting high-intensity electromagnetic radiation like lasers, and intense pulsed light equipment utilized for skin treatments such as resurfacing, tattoo removal, hair removal, or other skin-related procedures.
Numerous medical devices are employed on superficial areas of the human body. The key distinction of a medical device lies in its claim for medical use or association with aesthetic categories, setting it apart from cosmetic products.
For instance, a foot cream designed for moisturizing dry skin is considered a cosmetic product. However, if it includes a claim to heal damaged skin displaying cracks or fissures, it would be reclassified as a medical device.
Conclusion
Wrong product classification can negatively impact a business. It can have serious safety ramifications for the end user if the intended product use or function needs to be clarified or understood.
Other direct consequences can include potential product recalls, redesign of product labels, re-application or re‑notification to the appropriate competent authorities, reformulation of the product, and application for variation in some product class within the same regulatory framework. There is also the burden of associated costs, loss of brand reputation, loss of time, etc.
It is imperative that manufacturers, suppliers, and distributors correctly classify their products from the onset; this will subject the product to the appropriate regulatory framework and meet relevant compliance requirements.
In the case of uncertainty, the competent national authorities in the EU and UK Member States will decide on a case-by-case basis. Do you have questions about this topic, your obligations under the relevant regulatory framework, or a related topic?
As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices.
The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device.
Software as a Medical Device Introduction
The International Medical Device Regulators Forum (IMDRF) defines SaMD as “software intended for one or more medical purposes that perform those purposes without being part of a hardware medical device.”
FDA defines SaMD as “Software that meets the definition of a device in 181 section 201(h) of the FD&C Act and is intended to be used for one or more medical purposes without being part of a hardware device.”
The use of SaMD is experiencing a steady rise, with its application extending to various technology platforms such as medical device platforms, commercial “off-the-shelf” platforms, and virtual networks, among others.
This kind of software was previously referred to as “standalone software,” “medical device software,” or “health software” by industry professionals, international regulators, and healthcare providers, often leading to confusion with other software categories.
How Do I Know if My Product is SaMD?
As a member of the International Medical Device Regulatory Forum (IMDRF), the FDA recognizes the structural similarity between the two organizations’ definitions of SaMD. The definitions provided by the FDA and IMDRF highlight two criteria that must be satisfied for software to be designated as SaMD.
To evaluate if the Software is a medical device, it is important to assess its compliance with the regulatory authority’s definition. The IMDRF emphasizes that the Software must be “intended for one or more medical purposes”. On the other hand, the FDA references FD&C, or the Federal Food, Drug, and Cosmetic Act, Section 201(h), which outlines the definition of a device. This section defines a device as follows:
According to Section 201(h) of the FD&C, a device encompasses various articles such as tools, implements, instruments, machines, devices, appliances, in vitro reagents and other similar or related items, including components and accessories.
An article must also be legally recognised in the National Formulary, the United States Pharmacopoeia, or an analogous revision in order to meet the requirements of Section 201(h) of the FD&C Act’s definition of a device.
The product is intended to be used in the diagnosis of disease or other conditions as well as in the treatment, mitigation, treatment, or prevention of disease in people or animals, according to the definition of a device under FD&C Section 201(h).
In addition, a product must be intended to change any structure or function of the human or animal body without compromising its primary function for it to qualify as a device under Section 201(h) of the FD&C Act.
In addition, the definition of a device in Section 201(h) of the FD&C Act states that it must not achieve its primary purpose by chemical action in or on the human or animal body, nor must it rely on metabolism to achieve its purpose.
Note that the term “device” does not include software features that are excluded by Section 520(o). To apply this definition, it is essential to establish the intended use and indications for the use of your product. To refresh your understanding,
The intended use of a device refers to its designated purpose or the specific function for which the device is intended to be utilised. In other words, it defines the intended or intended application of the device
Indications for use pertain to the diseases or conditions that a device is designed to diagnose, treat, prevent, cure, or mitigate. These indications specify the target patient population and provide insights into why the device would be used on individuals with those diseases or conditions
Once the intended use and indications for the use of your product are defined, the second and third points in the FDA’s definition of a medical device will help determine whether your product falls under the regulatory scope of a medical device. These criteria will clarify whether your product meets the requirements for medical device regulation.
If you intend to market your software product in the United States, I recommend carefully reviewing the FDA’s guidance on Policy for Device Software Functions and Mobile Medical Applications.
This guidance provides valuable insights into the specific software functions that the FDA classifies as medical devices and functions that are not considered medical devices and, therefore, not subject to FDA regulation. Familiarizing yourself with this guidance will provide you having a thorough awareness of the regulatory environment for software products in the medical field.
If you’re still unsure about whether your product qualifies as a medical device, contacting the FDA directly for clarification is safest. Contacting the FDA now will provide reliable advice and ensure you receive accurate information tailored to your specific product and situation.
Is My Software Considered SaMD or SiMD?
When a product is found to fit the definition of a medical device, the second portion of the IMDRF and FDA definition of software as a medical device (SaMD) must be taken into account.
According to the IMDRF definition, Software must be used for its intended purpose only and must not be an integral part of a physical medical device.
According to the IMDRF, the FDA makes it clear that Software as a Medical Device (SaMD) is not a part of a hardware device and is instead intended for standalone usage for one or more medical purposes.
This further limit the scope of Software as a medical device (SaMD), as the Software used to operate or control a hardware device does not fulfil the requirements to be categorised as a SaMD. Instead, this type of Software is referred to as SiMD or “software in a medical device.”
Here are some examples of Software that assist in operating a hardware medical device, which falls under the category of Software in a Medical Device (SiMD) and not Software as a Medical Device (SaMD):
Software that controls the inflation or deflation of a blood pressure cuff
Software that controls the delivery of insulin on an insulin pump
Software used in the closed-loop control of a pacemaker.
“firmware,” or “micro-code,” indicating their classification as SiMD rather than SaMD.
To qualify as SaMD, a product must have standalone Software that independently carries out the functions defining it as a medical device, distinct from any associated hardware. The IMDRF guidance on “Possible Framework for Risk Categorization and Corresponding Considerations” further provides additional insights and clarifications regarding the SaMD definition.
1. SaMD is a medical device, including in-vitro diagnostic (IVD) medical devices.
2. SaMD can run on general-purpose computing platforms not specifically designed for medical purposes.
3. “Without being part of” means the Software is unnecessary for a hardware medical device to achieve its intended medical purpose.
4. Software intended to drive a hardware medical device does not meet the definition of SaMD.
5. SaMD can be combined, such as being integrated as a module, with other products, including medical devices.
6. SaMD can interface with other medical devices, including hardware medical devices, other SaMD software, and general-purpose Software.
7. Mobile apps that meet the defined criteria are considered SaMD.
Although it is crucial to distinguish between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), both types of Software adhere to many common standards for development, including the global standard for software lifecycle procedures is IEC 62304. lifecycle processes.
If your Software falls under the category of SiMD, you will still find the guidance documents and standards outlined in this guide valuable and applicable.
What are Some Examples of SaMD?
1. Software that enables a mobile device to view diagnostic images from MRI, ultrasound, or X-ray scans.
2. Software that utilizes image processing techniques to aid in detecting breast cancer.
3. Software that diagnoses a medical condition by analyzing data from the tri-axial accelerometer on a smartphone.
4. Software that collects real-time patient data monitored by a healthcare professional and utilized to develop treatment plans.
Clinical Evaluation
Clinical evaluation is a methodical and well-organized process that creates clinical evidence by continuously creating, collecting, analyzing and evaluating clinical data on SaMD to create clinical trials that review the clinical context and performance indicators of SaMD.
The quality and scope of the clinical assessment is based on the SaMD function for the clinical objective, which also ensures that the SaMD score is clinically valid and can be used consistently and predictably.
3 Clinical Evaluation Software
To qualify the software, the following three criteria must be met. To qualify your software, you must meet the three criteria outlined below.
Valid Clinical Association of a SaMD
Analytical/Technical Validation of a SaMD
Clinical Validation
1. Valid Clinical Association of a SaMD
Verifying that your software’s output corresponds to the targeted clinical conditions is the main goal here. Use of secondary data analysis, clinical trials (new data generated), professional society guidelines, original clinical research, literature searches, and/or secondary data analysis are all options for carrying out that task. All SaMD should show a reliable clinical association.
2. Analytical/Technical Validation
Does your software correctly process input data to generate accurate, dependable, and precise output data?” is the question we are attempting to answer in this context. Develop supporting documentation that demonstrates your SaMD’s output met your expectations in terms of technicality.
This action is being assessed by a manufacturer as part of the software’s validation and verification phase (V&V).
3. Clinical Validation
SaMD has been evaluated in your target population and for your intended use; users are able to achieve clinically significant results through consistent and dependable use.
