MDR Device Classification and Regulatory Guidelines

The European Union is an important market for all medical device manufacturers worldwide. The EU Medical Device Regulation (MDR) is implemented to harmonize and improve safety, efficacy and performance standards for medical devices. In this article, we focus on the EU MDR product classification and regulatory requirements such as CER, PMS, PSUR, PMCF and SSCP.

Device Classification According to MDR

The CE marking is a safety mark that is mandatory for products in thirty European countries, and obtaining the CE marking means that a product can legally enter the harmonized market of the EU. Depending on the risk level of a device under the MDR, there are different assessment routes for obtaining CE marking for a product.

The MDR categorizes medical devices into four classes based on their level of risk:

Class I: low-risk device. Class I medical devices can be subdivided into sterile conditions, measurement functions and reusable surgical instruments.

Class IIa: medium risk device. Unlike Class I devices, manufacturers of Class IIa devices must receive a declaration of conformity from a designated agency after a conformity assessment. Examples of this risk category include catheters, hearing aids or short-term contact lenses.

Class IIb: medium to high risk device. Its CE pathway requires the involvement of a designated agency. Examples of this risk category include devices such as incubators, insulin pens, long-term contact lenses and ventilators.

Class III: high risk device. They are subject to the most stringent requirements, including clinical evaluation of the device. This risk class includes pacemakers, artificial heart valves, surgical mesh, breast implants and other devices that require lifelong monitoring.

The EU uses a rules-based system to determine the risk class of medical devices. Appendix VIII of the MDR contains 22 rules for classifying medical devices. These rules are organized into four sections, with the rules in each section applying to the corresponding class of device.

• Rules 1-4 cover non-invasive devices
• Rules 5-8 cover invasive devices
• Rules 9-13 cover active devices
• Rules 14-22 are special rules that cover devices that do not fall into the first three categories (e.g., nanomaterials)

Overview of Requirements for Each Class of Device

Class I devices must meet the following obligations and technical requirements:

• Clinical Evaluation Report (CER)
• Post-Market Surveillance Program (PMS plan)
• Post-Market Surveillance Report (PMS report)
• Post-Market Clinical Follow-up Program (PMCF plan)
• Postmarketing Clinical Follow-up Report (PMCF report)

Class IIa, IIb, and III devices must meet the following obligations and technical requirements:

• Clinical Evaluation Report (CER)
• Post-Market Surveillance Program (PMS Plan)
• Periodic Safety Update Report (PSUR)
• Post-market clinical follow-up program (PMCF plan)
• Post-Marketing Clinical Follow-Up Report (PMCF report)
• Summary of Safety and Clinical Performance (SSCP)

Clinical Evaluation Report

The Clinical Evaluation Report (CER) is a clinical evaluation document required for each medical device marketed in the EU. Its purpose is to demonstrate that the device is capable of functioning as intended without compromising the safety of the end user.

MDCG-2020-13 provides a sample table of contents showing what a CER should include:

(1) Administrative details

• Medical device name, model and type
• Manufacturer name and SRN
• Notified body
• Type of evaluation
• Intended purpose
• Author check of the clinical evaluation report

(2) Reviewers involved in announcement organization assessment

(3) Device information

• Description
• Classification
• Clinical Evaluation Program
• Informational material provided by the manufacturer
• Adoption of common specifications and harmonized standards
• Proof of equivalence
• State-of-the-art

(4) Clinical literature review

(5) Clinical studies and related documents

(6) PMS, PMCF, and update programs

(7) IFUs, SSCPs, labeling and other information accompanying the device

(8) Summary of all available data and findings

(9) Conclusion

Post-Market Surveillance

The Post-Market Surveillance (PMS) plan is part of the required technical documentation for the device and details the strategy for ongoing monitoring and collection of device data and safety information. The plan is part of the PMS system requirements and is intended to outline the criteria for benefit-risk assessment of equipment and processes.

• Collecting and analyzing data
• Processing submitted complaints
• Communicate data to regulatory agencies and users
• Implementing corrective actions at the facility

In addition, the PMS program is used to determine the need for a Post-Market Clinical Follow-Up Program (PMCF).

EU MDR Annex III requires the following topics to be covered in the PMS plan:

• Systematic and proactive information collection process (user feedback, reports, etc.)
• Appropriate statistical and analytical methods for assessing collected data
• Assessment of revenue risk and thresholds for effective risk management
• Appropriate methods and tools for on-site collection of complaints and other feedback
• Methods for managing incidents subject to trend reporting
• Protocols for effective communication with competent authorities, notified bodies, economic operators and users
• Procedural references for fulfilling the manufacturer's obligations to the PMS system, the PMS program and the PSUR
• Procedures and systems for implementing corrective actions when necessary
• Effective tools for tracking and identifying devices that may require corrective action (e.g., traceability of potentially defective products in case a recall is required)

The Post-Market Surveillance Report (PMSR) is a summary of the results and conclusions drawn from the data generated as part of the PMS program. It is used primarily as part of the technical documentation for the device to demonstrate compliance with the MDR requirements for post-market surveillance. MDR Section 85 states that the PMSR must contain information summarizing the results and conclusions of the post-market data generated by the PMS program and must also provide the rationale and justification for any preventive and corrective actions taken.

Periodic Safety Update Report

The Periodic Safety Update Report (PSUR) was formally introduced in Article 86 of MDR 2017/745. The PSUR summarizes the results of post-market surveillance activities and the conclusions drawn by the manufacturer from them. If the manufacturer has taken corrective or preventive actions (CAPAs), a description and justification for these actions must also be included in this report. The PSUR is part of the device's technical documentation and must be updated throughout the device's lifecycle.

The PSUR is part of the device's technical documentation and must be updated throughout the life of the equipment. The PSUR is initially submitted to the Notified Body during the conformity assessment audit of the equipment, but must be updated annually or bi-annually from then on. It is the same as the PMSR with the addition that the manufacturer must publish the conclusions of the benefit-risk determination, key findings from post-marketing clinical or performance follow-up, sales volumes, and estimated user group characteristics and frequency of use.

Post-Marketing Clinical Follow-Up

The post-marketing clinical follow-up (PMCF) plan defines the methods and procedures used to proactively collect and evaluate clinical data on device performance and safety. As part of the technical documentation, the PMCF is used to update the PMS Plan and CER, and also serves as a template for PMCF reporting.

The goals of the PMCF are to identify previously unknown side effects, assess urgent risks, and prevent off-label misuse. In general, PMCF programs are divided into seven sections:

• Manufacturer's contact information
• Description and specifications of the medical device being studied
• PCMF-related activities (general and specific methods and procedures)
• References to any relevant parts of the technical documentation
• Evaluation of clinical data for equivalent or similar devices
• Citation of any applicable generic specifications, harmonized standards, or guidance documents
• Expected date for the PMCF assessment report

The PMCF report is a structured summary of the PMCF program outcome data and should be included as part of the clinical assessment report and technical documentation. Documentation and reporting of adverse events and serious adverse events is a key aspect of a successful clinical study and ensures compliance with the latest regulatory requirements.

PMCF report is required by MDR Annex XIV Part B. Further guidance is provided in MDCG 2020-8 which outlines the reporting requirements and provides a template.

PMCF activities must follow the latest requirements of the GCP. As part of the GCP, manufacturers are required to notify the competent authorities of previously unrecorded serious events (e.g. previously unknown side effects). In addition, this event needs to be clearly described in the product documentation before introducing the device to the EU market.

Summary of Safety and Clinical Performance

Summary of safety and clinical performance (SSCP) is an external document containing information related to a medical device, such as general information, a summary of clinical data collected from the device, or possible therapeutic alternatives. The SSCP applies to high risk or invasive devices.

MDCG 2019-9-Rev.1 states that the SSCP must contain at least the following sections:

• General device and manufacturer details - including UDI details
• Intended purpose
• Indications, contraindications and the target population
• Description of the device, its components, medicinal products and any previous versions of the device
• Residual risks, warnings and precautionary details
• Summary of the clinical evaluation of the device, emphasizing the PMCF evaluation and noting conclusions related to safety and performance
• Description of the necessary training and qualifications
• Reference to applicable harmonized standards and generic specifications
• Record of revisions

Proregulations can provide timely support and services in various aspects such as risk management and product assessment of medical devices in the EU, helping manufacturers to comply with the strict EU MDR. Contact us to find out how we can get your product into and successfully operate on the EU market.