EU-MDR Compliance, Prosenso

The European Union’s Medical Device Regulation (MDR) No. 2017/745 introduces a comprehensive framework that significantly influences the supply chain of medical devices, including medical gloves, by emphasizing a risk-based classification system pivotal for ensuring user safety and device efficacy. This EU medical device classification underpins the regulatory compliance for manufacturers and suppliers, demanding adherence to stringent requirements that consider the vulnerability of the human body and potential risks associated with medical devices, including the need for a quality management system, conformity assessment by a notified body, and the preparation of technical documentation.

Under the EU MDR, medical devices are meticulously categorized into four classes—Class I, Class IIa, Class IIb, and Class III—with each classification denoting a specific set of regulatory obligations. For medical gloves, understanding where they fall within this classification is essential for complying with the EU MDR, which encompasses fulfilling demands for clinical evaluation, authorization by an authorized representative, and a declaration of conformity. This guide aims to navigate through the classification of medical gloves under MDR, underscoring the importance of the EU MDR, quality management system, notified body involvement, and technical documentation requirements for ensuring market compliance.

Understanding MDR (Medical Device Regulation)

The European Union’s Medical Device Regulation (MDR), officially known as Regulation (EU) 2017/745, represents a significant overhaul of the previous regulatory system for medical devices within the EU. This regulation, which became fully applicable on May 26, 2021, sets a new standard for the monitoring, design, and distribution of medical devices to enhance patient safety and ensure high-quality products on the market.

Key Aspects of the EU MDR

  1. Scope and Applicability: The MDR affects a broad range of stakeholders including manufacturers, authorized representatives, importers, and distributors of medical devices in the EU. It also impacts regulatory affairs and quality management professionals who are involved with medical devices.
  2. Classification System: Medical devices are classified based on a risk-based system, considering the potential risks associated with the devices and their intended purpose. This system categorizes devices into four classes: Class I, Class IIa, Class IIb, and Class III, with Class I being the lowest risk category.
  3. New Responsibilities: The regulation assigns new or revised responsibilities to the European Medicines Agency (EMA) and national competent authorities. These include oversight of medicines with an integral medical device, devices containing ancillary medicinal substances, and devices made from substances absorbed by the human body.
  4. Conformity Assessment and CE Marking: All medical devices must undergo a conformity assessment to receive CE marking, which indicates compliance with the MDR. The assessment’s complexity varies according to the device’s risk class.
  5. Unique Device Identification (UDI) System: To improve traceability and safety, the MDR requires that all medical devices be assigned a UDI code. This system does not apply to custom-made and investigational devices.
  6. Enhanced Clinical Oversight: The MDR introduces more stringent requirements for clinical investigations, incorporating Good Clinical Practice guidelines. This is aimed at ensuring that medical devices are thoroughly tested and safe for use before they reach the market.
  7. Post-Market Surveillance: Vigorous post-market surveillance is mandated to monitor the performance and safety of medical devices after they have been released to the market. This includes the obligation for companies to report any serious incidents or corrective actions taken in the field.

The EU MDR not only aims to protect public health but also to maintain the EU market’s integrity by ensuring that only compliant and safe medical devices are available to consumers. This regulatory framework is crucial for medical device companies that wish to enter or continue operating in the European market, emphasizing the importance of compliance to avoid penalties and product recalls.

Classification of Medical Gloves under MDR

Under the European Union’s Medical Device Regulation (MDR), medical gloves are meticulously classified to ensure they meet stringent safety and performance standards before they can be marketed within the EU. This classification is primarily based on the intended use of the gloves and the potential risks involved during their application.

Factors Influencing Classification

  1. Intended Purpose and Inherent Risks: Medical gloves are classified into Class I, Is, and IIa, with each class reflecting the level of risk associated with the glove’s intended use.
  2. Subcategories of Class I: Class I devices are further divided based on specific functionalities:
    • Is – Sterile condition
    • Im – Measuring function
    • Ir – Reusable surgical 
  3. Duration of Use and Invasiveness: The length of time the gloves are intended to be in contact with the patient and the degree of invasiveness also play a crucial role in classification.
  4. Additional Considerations: Factors such as whether the gloves have a measuring function or if they are active medical devices are also considered.

Specific Classifications for Medical Gloves

  • Standard Medical Examination Gloves: These are typically classified as Class I medical devices if they are non-sterile. Non-sterile medical examination gloves are intended to protect the patient and user from contamination and are classified as low risk.
  • Sterile Medical Examination Gloves: These are classified as Class Is, requiring additional regulatory controls due to their sterile nature.
  • Surgical Gloves: These are typically classified as Class IIa medical devices. They are intended for use during invasive surgical procedures and are classified at a higher risk level due to the critical role they play in preventing infections.
  • Dual Purpose Gloves: Gloves that serve more than one function must comply with all relevant regulations and undergo appropriate conformity assessment procedures.
  • PPE Gloves: Distinct from medical gloves, PPE gloves are categorized based on their design complexity into Simple Design (Category I), Intermediate Design (Category II), or Complex Design (Category III).

Labeling and Compliance

Under the MDR, it is mandatory for non-sterile medical gloves to be clearly labeled as “Exam Gloves” or “Medical Examination Gloves.” This labeling is crucial for ensuring that the gloves are used correctly and safely in medical settings.

In summary, the classification of medical gloves under the MDR is determined by multiple criteria including the duration of contact with the body, the degree of invasiveness, and the potential risks associated with their use. These classifications dictate the level of regulatory control and the necessary steps manufacturers must take to ensure compliance, including clinical evaluations, conformity assessments, and post-market surveillance.

Conformity Assessment Procedures for Medical Gloves

Overview of Conformity Assessment

The conformity assessment for medical gloves, particularly under the EU MDR, is a critical process to ensure that gloves meet all regulatory requirements before they can enter the market. This assessment varies significantly depending on the class of the medical glove.

Step-by-Step Conformity Assessment Process

  1. Technical Documentation Preparation: Manufacturers must prepare comprehensive technical documentation that demonstrates conformity to safety and performance standards. For Class I medical gloves, this includes a declaration of conformity and ensuring the product meets general safety and performance requirements. Class Is devices require additional notified body involvement for sterility aspects.
  2. Clinical Evaluation: Class I non-sterile devices do not require clinical investigations but must still meet general safety and performance requirements. For Class III and certain Class II devices, a more rigorous premarket clinical investigation is required.
  3. Post-Market Surveillance: Manufacturers of Class I medical gloves must also prepare a post-market surveillance report to monitor the gloves’ performance after they have entered the market.
  4. Periodic Safety Update Reports: For Classes IIa, IIb, and III, a periodic safety update report is necessary to continuously assess the risk-benefit balance of the gloves.
  5. Involvement of Notified Body: The involvement of a notified body is mandatory for higher class devices, where they assess the conformity of the gloves with the regulatory standards.
  6. CE Marking: The CE mark, along with the notified body’s number if applicable, must be affixed to the medical gloves to signify compliance with the MDR.
  7. Quality Management System: Establishing a quality management system compliant with ISO 13485:2016 is essential for maintaining regulatory compliance.
  8. Regulatory Compliance Officer: A designated person responsible for regulatory compliance must ensure all regulatory, surveillance, and documentation aspects are adhered to before the gloves can be marketed.

Unique Device Identification (UDI)

For Class III implantable devices, it is mandatory for economic operators and health institutions to maintain a record of the UDI, ensuring traceability throughout the supply chain.

Special Provisions

Custom-made and investigational devices follow specific provisions under the MDR to ensure they also meet safety and performance standards despite their unique characteristics.

Clinical Evaluation and Investigation Requirements

Overview of Clinical Evaluation and Investigation

Clinical evaluation and investigation are indispensable components in the lifecycle of medical devices, including medical gloves, under the EU Medical Device Regulation (MDR). These processes are designed to ensure that medical devices are safe and effective for their intended use.

Key Components of Clinical Evaluation

  1. Systematic Process: Clinical evaluation is a systematic and ongoing process that involves generating, collecting, analyzing, and assessing clinical data related to a medical device.
  2. Methodology and Documentation: The process should follow a defined, methodologically sound procedure and include a thoroughly documented critical evaluation of all clinical investigations.
  3. Literature Review: It involves a review of relevant scientific literature, findings from clinical investigations, and evaluations of equivalent products or types.
  4. Continuous Requirement: Clinical evaluation is not just a one-time requirement but continues throughout the device’s lifecycle, including initial CE marking and regular updates thereafter.
  5. Safety and Performance Verification: The evaluation verifies the clinical safety and performance of the device when used as intended. These results contribute to ongoing risk analysis, identifying hazards and estimating risks.

Clinical Investigation Specifics

  • Premarket Investigation: For implantable and Class III devices, a premarket clinical investigation is mandatory to assess their safety and efficacy before they are marketed.
  • Risk-Based Approach: The extent of clinical investigation varies depending on the class of the device, with Class III devices undergoing the most stringent evaluations due to their higher risk level.
  • Performance and Benefit Distinctions: The MDR makes clear distinctions between “performance,” “clinical performance,” and “clinical benefit,” which are crucial during clinical investigations.

Safety Reporting and Compliance

  • Safety Reporting: The rules for safety reporting during clinical investigations are specifically tailored to whether the devices are used within their intended purposes.
  • Submission of Reports: After the completion of clinical investigations, sponsors must submit detailed clinical investigation reports to the regulatory authorities of all EU member states where the investigations were conducted.

By adhering to these stringent clinical evaluation and investigation requirements, manufacturers of medical gloves can ensure compliance with the EU MDR, ultimately enhancing the safety and efficacy of their products in the market.

Post-Market Surveillance and Vigilance

Overview of Post-Market Surveillance (PMS)

Post-market surveillance (PMS) is a systematic approach to gathering and analyzing data on medical devices that have been placed on the market. It aims to ensure ongoing safety and effectiveness through active data collection and evaluation. This process is crucial for identifying any necessary corrective or preventive actions during the device’s lifecycle.

Key Steps in Post-Market Surveillance

  1. Collection of Data: Manufacturers must actively and systematically gather, record, and analyze data related to the quality, performance, and safety of medical gloves.
  2. Surveillance Report Preparation: For Class I medical gloves, a post-market surveillance report must be prepared and maintained, detailing the findings and any actions taken.
  3. Periodic Safety Update Reports: For medical gloves classified as Class IIa, IIb, and III, periodic safety update reports are required to continuously assess the risk-benefit balance.
  4. Clinical Evaluation Updates: Manufacturers are required to update the clinical evaluation of the medical gloves with clinically relevant information obtained from post-market surveillance, particularly from post-market clinical follow-up.

Vigilance System

The Medical Device Vigilance System plays a pivotal role in improving health and safety by reducing the likelihood of medical device incident recurrence. It includes several critical components:

  • Evaluation of Adverse Incidents: Adverse incidents involving medical gloves are evaluated to understand their nature and cause.
  • Dissemination of Information: Information about significant incidents is shared through National Competent Authority Reports (NCAR), enhancing industry-wide awareness and preventive measures.
  • Field Safety Corrective Actions: If incidents recur, field safety corrective actions are implemented to prevent future occurrences.

Roles of Economic Operators and Distributors

  • Compliance Checks: Distributors must ensure that medical gloves are compliant with the MDR, stored correctly, and transported under appropriate conditions. They also handle complaints and engage in surveillance activities.
  • Verification of Compliance: Each economic operator is responsible for verifying that the preceding operator in the supply chain complies with the MDR.
  • Guidance from the European Commission: The European Commission provides documents to help operators verify the lawful market placement of medical devices and PPE.

Enforcement by EU Authorities

Authorities in EU countries enforce market surveillance by ensuring compliance with Medical Device Directives. This includes implementing safeguard clause procedures for unsafe devices, addressing incorrectly affixed CE markings, and setting specific health monitoring measures.

Eudamed2 Database

Eudamed2, the European Databank on Medical Devices, is a crucial tool for storing comprehensive information about medical devices. It includes details on manufacturers, authorized representatives, device registration, certificates, and data from the Medical Device Vigilance System.

Traceability and UDI System

Unique Device Identification (UDI) System

The UDI system is a cornerstone of traceability within the EU medical device framework, enhancing the oversight of medical devices throughout their lifecycle. This system comprises two main components: the UDI Device Identifier (UDI-DI) and the UDI Production Identifier (UDI-PI).

UDI Components and Placement

  1. UDI-DI: This identifier is specific to a manufacturer and a device, providing crucial access to device information.
  2. UDI-PI: Identifies the unit of device production and packaged devices, crucial for tracking and logistics.
  3. Placement: The UDI carrier must be placed on the device label, all higher levels of packaging, and directly on reusable devices.

Responsibilities of Manufacturers

  • Assignment of UDI: Manufacturers are tasked with assigning a UDI to each device and maintaining this identifier across all packaging levels.
  • Eudamed Submission: They must also submit the required UDI information to the European Database on Medical Devices (Eudamed).
  • Basic UDI-DI: A Basic UDI-DI is assigned to devices as the main key in Eudamed and related documentation, ensuring consistency in device identification.

UDI in Practice

  • Packaging Requirements: UDI carriers are necessary on the packaging of single-use class I and IIa medical gloves. If healthcare providers lack access to higher packaging levels, UDI carriers must appear on individual device packaging.
  • Compliance Timeline: UDI-DI and UDI-PI are mandatory on packaging but are not required for class 1 medical devices until May 2025.

Traceability and Compliance Requirements

Traceability within the EU medical device sector is governed by a set of stringent requirements that vary depending on the device class and its intended use.

Key Traceability Requirements

  • Class III Implantable Devices: Economic operators and health institutions must keep records of the UDI of devices they supply or receive.
  • Class II and III Devices: Information on the Member States where these devices are available must be provided during device registration.
  • Safety and Clinical Performance: For single-use class I and IIa devices, a summary of safety and clinical performance is required, enhancing the transparency and accountability of device monitoring.

Industry Examples and Enforcement

  • Prosenso ApS: This company exemplifies industry compliance by registering its gloves under both the EU Personal Protective Equipment Regulation and the EU MDR, featuring a Basic UDI-DI on their Declarations of Conformity.
  • Regulatory Oversight: EU authorities enforce traceability by mandating the recording of UDI and monitoring the market placement of medical devices, ensuring that only compliant devices are distributed within the market.

Conclusion

Through this comprehensive exploration, we’ve delved into the intricate landscape of EU MDR compliance, specifically regarding medical gloves. Key points such as the significance of understanding the EU medical device classification, the necessity of a robust quality management system, the roles of notified bodies, and the stringent requirements for technical documentation offer a roadmap for manufacturers navigating the regulatory complexities. This guide underscores the meticulous classification of medical gloves under the MDR, highlighting how this classification directly influences compliance procedures, from clinical evaluation to post-market surveillance, ultimately aiming to enhance patient safety and product efficacy on the market.

The discussion on conformity assessment procedures, clinical evaluation, and the importance of post-market surveillance elevate the understanding of the regulatory demands placed on medical glove manufacturers. It underscores the broader implications of these regulations for ensuring the high quality and safety of medical devices within the EU. By adhering to these guidelines, manufacturers not only meet legal requirements but also contribute significantly to public health protection. As the medical device industry continues to evolve, further research and adherence to these evolving standards will be paramount in fostering innovation while ensuring safety and compliance in the dynamic EU market.

FAQs

How are medical devices categorized for classification under EU MDR?

Medical devices are classified according to Annex VIII of the EU MDR, which is divided into four main subsections: non-invasive devices, invasive devices, active devices, and a set of “special” rules. The special rules are applicable to devices that may already be categorized under the first three sections, and they must always be taken into account during the classification process.

What are the requirements to ensure compliance with EU MDR?

To comply with the EU Medical Device Regulation (MDR), manufacturers must provide extensive documentation, including the General Safety and Performance Requirements (GSPR) outlined in Annex I, establish a Quality Management System (QMS) as per Article 10, prepare Technical Documentation as specified in Annex II, compile a Clinical Evaluation Report (CER) according to Annex XIV, and develop a Post-Market Surveillance Plan in line with Annex III.

What criteria are used to classify medical devices, particularly in the context of the FDA?

The classification of medical devices by the FDA is primarily based on the level of risk they present. Class I devices are considered low risk, Class II devices carry a moderate risk level, and Class III devices are classified as high risk, being the most stringently regulated due to their potential impact on patient health and safety.

What does Rule 14 of the MDR entail for distributors?

Rule 14 of the MDR, outlined in Article 14, sets forth the general obligations of distributors. Distributors must fulfill requirements related to the availability of devices, compliance with registration obligations, and ensuring that devices supplied are in conformity with MDR. Distributors may utilize a sampling method that is representative of the devices they supply to meet these obligations.