An Overview: CE Marking for Medical Devices and IVDs
CE marking is the certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). In this article, we will dive into medical device and IVD device CE marking nuances, MDR & IVDR classification differences, risk analysis based on ISO 14971 requirements, clinical evaluation per Art.60 of the MDD II revised in accordance to Annex XIV Part B template, (Annex XI) for performance evaluation according to IVDR
Medical Device CE Marking
The CE marking for medical devices guarantees that the products comply with the high standards of the European Medical Device Regulation (MDR 2017/745). Medical devices are categorized by the MDR due to the risk they present: these categories include Class I (low risk), Class IIa (medium risk), Class IIb (higher tier of media such as drug-eluting stents or closed-loop blood glucose sensors) and Class III (high-risk e.g, implantable pacemakers). Manufacturers require indications of conformity by linking quality management systems and technical documentation to clinical evaluations. Steps in the CE marking process
Identify the risk Class of the device as per MDR.
Compliance with certification: self-declared for class I within each type, notified body involved in higher risk Class IIa Certification of design dossier (Type Examination) and technical file (Annex V).
Technical Documentation – detailed documentation for a device description, of design and development information as well as regarding risk management and clinical data
Clinical Evaluation- As per MDR article 61, a clinical evaluation report (CER) is required to show the safe performance of the device based on its clinical data.
Declaration of Conformity- The manufacturer states formally that the device complies with all regulatory requirements.
Place CE Marking- After the conformity has been shown, a device will bear its CE marking.
CE Marking for IVD Devices
In Vitro Diagnostic (IVD) are medical devices regulated under the In-Vitro Diagnostic Regulation (IVDR 2017/746). The IVDR classifies IVDs into four classes (A, B, C, D) according to the risk involved- Class A corresponds with small risks and D stands for high. Below are the steps to CE marking for IVDs, a similar but different pathway:
Categorisation- Assigning the class of risk for IVD as per IVDR.
Performance Assessment-Annex XIII Part A requires you to show analytical and clinical performance.
Technical documentation (design data, production and performance records),
Conformity Assessment- Notified body assessment for higher-risk classes
EU IVDR Declaration of Conformity- Asserting compliance with EU IVDR requirements
CE Marking CE marking is the affixation of the product with CE mark once verification of conformity.
MDR Classification
Medical devices are categorized according to risk, duration of use and invasiveness (Chapter IV MDR)
First-class: e.g., bandages and reusable surgical instruments
Class IIa – Dental fillings, surgical clamps
Class IIb: high-risk devices, e.g. ventilators or infusion pumps
Class III: These devices are high-risk and include heart valves as well as implanted defibrillators.
The MDR classification also determines the scrutiny level and involvement of a notified body in conformity assessment.
IVDR Classification
IVDR classification IVDs into four risk classes,
Class A: These are the devices that pose the lowest risks, for instance, laboratory instruments.
Class B:Medium-risk, such as a pregnancy test
Group C: Devices that have non-invasive examination features but are used to diagnose or monitor patients with a high degree of risk (eg blood glucose monitors).
Class D: The riskiest devices such as HIV or hepatitis tests.
Performance evaluation and conformity assessment are required in different procedures according to the related classification.
ISO 14971 Risk Analysis
ISO 14971 is the standard recommended in the risk management of medical devices framework. That means it is a method of identifying, evaluating and controlling risks during the entire life cycle of products. Key elements include:
Hazard Identification: Risk assessment for the device.
Risk evaluation: the assessment of the risks associated with that hazard and judgements made as to whether they are acceptable or not
Mitigation measures of the identified risks by Risk mitigation.
Residual Risk Evaluation: Evaluate the risks that remain after all control measures have been applied.
That standard is crucial if Devices with the MDR or IVDR are to be safe and effective.
Clinical Evaluation under MDR Article 61
Clinical evaluation, is the process of verifying safety and performance related to clinical data for every medical device as specified in Article 61 MDR. This process includes:
Clinical Review Evaluating the available clinical data in the literature.
Clinical Trials New clinical trials if required
Post-market surveillance and updating clinical evaluations, where necessary Monitoring
A technical documentation for CE marking must include a clinical evaluation report (CER).
IVDR Performance Evaluation Annex XIII Part A
Performance evaluation Article 61 – General requirements Annex XIII Part A of the IVDR stipulates how performance evaluations should be carried out. This includes:
Scientific Validity Showing an analyte is associated with a clinical phenotype
High-quality diagnostic performance: Accuracy, Precision, Sensitivity and Specificity of the IVD
Analytical validation: Assuring that the IVD could measure levels of p24, gp120, etc.
Performance evaluation Part of the validation and verification process for assuring IVD performance is assessing its reliability and precision.
Conclusion
CE marking for Medical devices and IVD is the most challenging one but as well achieved to conform all essential requirements including high safety & performance standard. Compliance with MDR or IVRD standards ensures that the products manufacturer meet EU requirements via comprehensive approach for risk analysis and meticulous clinical/performance evaluations. If you are in compliance, not only will it make market access easier but ultimately your patients benefit while promoting better quality of the product.
