Classification of Borderline Medical Devices and Associated PMS Activities

Classification of Borderline Medical Devices and Associated PMS Activities

Borderline medical devices are challenging to classify because they lie at the intersection of multiple regulatory frameworks, such as those for medical devices and medicinal products. The MDCG 2022-5 Rev.1 guidance provides detailed criteria and examples to help manufacturers and regulators properly classify these products under Regulation (EU) 2017/745 (MDR).

To determine if a product qualifies as a medical device under the MDR, the following steps should be followed:

1. Assess the Intended Purpose:
   • Determine if the product is intended for one or more specific medical purposes listed in Article 2(1) MDR, such as:
     • Diagnosis, prevention, or treatment of diseases.
     • Monitoring or compensation for injuries or disabilities.
     • Investigation, replacement, or modification of anatomical structures or physiological functions.
2. Evaluate the Principal Mode of Action:
   • Confirm that the product achieves its primary effect by physical, mechanical, or chemical action, rather than pharmacological, immunological, or metabolic means.
   • Products with an ancillary pharmacological effect but a primary physical action can still qualify as medical devices.
3. Follow the Decision-Making Flowchart:

• Assess the intended purpose of the product.
• Determine the primary mode of action.
• Evaluate whether the product meets MDR requirements.
• Decide if the product’s pharmacological, immunological, or metabolic effects are ancillary.

Challenges in Classification

Some products present overlapping properties, requiring careful analysis:

• Substance-Based Devices: These may appear similar to medicinal products but can be classified as medical devices if their primary action is non-pharmacological.
• Combinations with Medicinal Products: Devices incorporating medicinal substances must determine whether the substance’s action is principal or ancillary to the device’s primary function.

Examples from the MDCG Guidance

The MDCG document provides useful examples of classifications:

• Medical Devices:
  • Sutures: Absorbable or non-absorbable, relying on physical action.
  • Wound Dressings: Hydrocolloid or hydrogel products acting primarily through absorption or protection.
  • Intrauterine Devices: Without drug-releasing properties.
• Medicinal Products:
  • X-ray Contrast Agents: Providing pharmacological effects in diagnostic imaging.
  • Antiseptic Solutions: Used on non-intact skin or pre-surgery.
• Borderline Examples:
  • Bone Cements with Antibiotics: Classified as medical devices if the antibiotic’s action is ancillary to the physical function of the cement.

Post-Market Surveillance (PMS) Activities for Borderline Devices

PMS activities are mandatory for all products classified as medical devices under the MDR. Borderline products classified as medical devices must comply with the following PMS requirements:

1. PMS Plan Development:
   • Manufacturers must prepare a PMS plan as part of the technical documentation (Annex III of MDR).
   • The plan should outline methods for monitoring device performance and collecting data on safety and clinical effectiveness.
2. Periodic Safety Update Reports (PSUR):
   • Class IIa, IIb, and III devices must have a PSUR that is updated regularly and submitted to notified bodies.
   • The report must include a summary of PMS data, any updates to the risk-benefit analysis, and conclusions from the data analysis.
3. Proactive Data Collection:
   • For borderline devices with high safety or performance risks (e.g., substance-based devices with systemic effects), proactive PMS strategies such as Post-Market Clinical Follow-up (PMCF) may be required.

4. Incident Reporting:
   • Manufacturers are obligated to report incidents, including malfunctions or adverse effects, to the competent authorities as part of their PMS obligations.
5. Trend Reporting:
   • Trends in non-serious incidents or deviations from expected device performance must also be monitored and reported.

Manufacturers’ Responsibilities

Manufacturer should :

• Provide detailed justifications for product classification in the technical documentation (Annex II, MDR).
• Base classification on state-of-the-art scientific evidence.
• Implement a robust PMS system that complies with MDR requirements.
• Consult with notified bodies or competent authorities for borderline cases, ensuring clarity and compliance.

Conclusion:

Borderline medical devices require careful classification under MDR, focusing on intended purpose, primary mode of action, and ancillary effects. MDCG 2022-5 Rev.1 provides clear criteria and examples, aiding manufacturers in justifying classifications with robust evidence and meeting PMS requirements.

---