Qualification of Medical Devices and IVDs – Does Your Product Fall Under MDR or IVDR?
Device qualification is the first step in the regulatory process. Its purpose is to determine whether a product meets the definition of a medical device or an in vitro diagnostic (IVD) device according to Article 2 of the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR). A product must have an intended medical, diagnostic, or therapeutic purpose, and its principal action must not be achieved by pharmacological, immunological, or metabolic means.
The qualification process includes analyzing the technical documentation, product functionality, intended purpose, and claimed mechanism of action. In borderline cases, manufacturers should refer to MDCG guidance (e.g., MDCG 2021-24 for IVDs or MDCG 2021-13 for software) or consult with competent authorities in EU Member States.
Correct qualification directly impacts the certification process and the selection of a notified body. An incorrect assignment may lead to rejection of the documentation, delays in registration, or penalties from market surveillance authorities.
Who Is Responsible for Classification – Manufacturer or Notified Body?
Under MDR and IVDR, the manufacturer is responsible for classifying the device. The classification must be based on objective technical data and justified in the documentation. For devices above Class I, the notified body reviews the assigned risk class. If the classification is incorrect, the notified body may reject the application or require a different conformity assessment procedure.
Classification Criteria for Medical Devices – MDR
The classification process for medical devices must follow four key criteria listed in Annex VIII of MDR:
- Intended function and whether the device is reusable,
- Level of invasiveness and site of contact with the body,
- Duration of continuous use,
- Application of the MDR classification rules.
Level of Invasiveness and Activity
- Non-invasive: Devices that do not penetrate the body and are used externally.
- Invasive: Devices that partially or fully penetrate the body through the skin or a natural orifice.
- Active: Devices that operate using energy sources other than the human body (e.g., electricity, radiation).
Classification by Duration of Use
- Transient: Less than 60 minutes of continuous use.
- Short-term: From 60 minutes to 30 days.
- Long-term: More than 30 days.
Classification Rules – MDR Annex VIII
The MDR includes 22 classification rules. If multiple rules apply, the rule leading to the higher risk class takes precedence. Classification must always be based on the intended use:
- Software is classified according to its function and clinical impact,
- Calibrators and control materials are classified in line with the target device,
- The intended use, not possible misuse, determines classification.
Medical Device Risk Classes under MDR
- Class I: Low-risk devices – self-certified, except for sterile, measuring, or reusable instruments.
- Class IIa: Medium-risk devices, e.g., dental implants, infusion pumps.
- Class IIb: Higher-risk devices, e.g., dialysis systems, long-term cardiovascular implants.
- Class III: Highest-risk devices, e.g., cardiac implants, devices in contact with the central nervous system.
Classification of IVD Devices under IVDR
The IVDR divides IVDs into four risk classes – A, B, C, and D – depending on their impact on public and individual health:
- Class A: Lowest risk – general laboratory devices (e.g., sample containers, diluents).
- Class B: Moderate risk – e.g., pregnancy tests, glucose meters.
- Class C: High risk – e.g., oncology panels, HLA typing.
- Class D: Highest risk – e.g., HIV, HBV, HCV tests, blood screening.
MDR vs. IVDR – Key Differences in Classification
Both MDR and IVDR use risk-based classification but differ in their structure. Below is a comparison:
| Aspect | MDR – Medical Devices | IVDR – IVD Devices |
|---|---|---|
| Risk Classes | I, IIa, IIb, III | A, B, C, D |
| Main Criterion | Contact with the body, invasiveness | Impact of the result on diagnosis or treatment |
| Self-Certification | Only Class I (except sterile/measuring devices) | Only non-sterile Class A devices |
| Guidance Documents | MDCG 2021-13 (software) | MDCG 2021-24 (performance evaluation) |
Transitional Periods – Regulation 2023/607
Devices certified under the previous directive (IVDD) can benefit from transition periods if they comply with post-market surveillance requirements and no significant changes have been made:
- Class D – until 31 December 2027
- Class C – until 31 December 2028
- Class B and sterile Class A – until 31 December 2029
How Pure Clinical Can Support Device Classification
Pure Clinical provides expert support for medical device and IVD manufacturers, including:
- Analysis of product functionality and intended purpose,
- Assignment to the appropriate class and classification rule,
- Preparation of justification for classification and regulatory strategy,
- Guidance on selecting the correct conformity assessment procedure and notified body.
We ensure alignment with MDR, IVDR, and MDCG guidance for both conventional and innovative technologies.
FAQ
How can I determine whether a product falls under MDR or IVDR?
What should I do if my product is a borderline device?
A borderline device is one for which qualification as a medical device or IVD is not clear-cut. In such cases, manufacturers should consult national regulatory interpretations, relevant MDCG guidance, and—if necessary—seek clarification from a competent authority.
Can the risk class of a device be changed during conformity assessment?
Does device qualification need to be documented?
Who is responsible for the final classification of the device?
Does the classification affect the selection of a notified body?
Yes. Higher-risk classes require more rigorous conformity assessment procedures and necessitate selection of a notified body with the appropriate scope of designation and technical competence.