Overview of Manufacturer Responsibilities
In Lebanon, the responsibility for classifying medical devices lies solely with the manufacturer. This classification is determined by the intended purpose of the device rather than any unintended uses (such as off-label applications).
Guidelines for Risk Classification
1. Intended Purpose
The classification is based on the manufacturer’s intended use. Off-label uses do not influence the classification.
2. Combination Devices
Devices that are intended for use in conjunction with other devices must be classified independently.
3. Accessories
Accessories associated with a primary device are classified separately, taking into account their own intended use.
4. Software Classification
– Software that influences or drives the use of a device must be classified with the same risk classification as the device it supports.
– Conversely, independent software should be classified based on its own risk profile.
5. Multiple Uses
If a device serves various purposes, it should be classified according to the use that presents the highest risk.
6. Multiple Classification Rules
When applicable rules lead to multiple classifications, the classification resulting in the highest risk level takes precedence.
Regulatory Framework in Lebanon
Lebanon’s Ministry of Public Health (MoPH), through its Medical Devices Department, oversees the regulation, registration, and importation of medical and IVD devices. The Lebanese system follows the European Union (EU) model, adopting the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) as reference frameworks.
Manufacturers or importers must:
- Provide proof of CE marking, FDA clearance, or ISO 13485 certification.
- Submit technical documentation and declarations of conformity for review.
- Classify devices according to EU standards (Classes I–III for medical devices and A–D for IVDs).
Only registered devices that comply with these standards may be marketed or imported in Lebanon.
Risk Classification of Medical Devices
Medical devices are categorized into four groups based on their risk profiles: Class I, IIa, IIb, and III.
– Class I (Low Risk): Involves devices that pose minimal risk, such as everyday health appliances. Manufacturers must provide an EU declaration of conformity and compile technical documentation.
Example: Thermometers, stethoscopes, bandages.
– Class Is: Related to sterile devices, requiring certification for manufacturing under strict sterility standards.
Example: Sterile bandages or surgical gloves.
– Class Im: Devices that measure, necessitating compliance with metrology standards, in addition to the technical files and certification.
Example: Blood pressure monitors or weighing scales.
– Class Ir: Reusable surgical instruments, requiring a technical file that demonstrates reuse safety, along with EU-notified body certification.
Example: Reusable surgical scissors.
– Class IIa (Low to Medium Risk): Covers devices that are implanted for short durations (between 60 minutes to 30 days). Compliance entails an EU declaration of conformity, technical documentation, and a conformity assessment by an EU-notified body following relevant annexes.
Example: Dental fillings, hearing aids, suction equipment.
– Class IIb (Medium to High Risk): Encompasses devices implanted for a longer duration (over 30 days). Similar compliance requirements apply as Class IIa, but with more stringent assessments for the technical documentation of implantable devices.
Example: Infusion pumps, ventilators, X-ray machines.
– Class III (High Risk): Includes life-sustaining devices. The compliance process mirrors that of Class II devices but is subject to stricter scrutiny, requiring a comprehensive evaluation by an EU-notified body.
Example: Pacemakers, heart valves, implantable defibrillators.
Risk Classification of IVD Medical Devices
In vitro diagnostic (IVD) devices also follow a classification scheme divided into four classes: A, B, C, and D.
– Class A (Low Risk): Devices that present low individual and public health risk. If marketed in a sterile state, they require a notified body for the conformity assessment of sterilization.
Example: Sample containers, laboratory reagents.
– Class B (Moderate Risk): Devices with moderate individual risk or low public health risk, necessitating conformity assessment by a notified body.
Example: Pregnancy test kits, urinalysis strips.
– Class C (High Individual Risk): Devices that pose a significant individual risk or moderate risk to public health, which also require a notified body’s involvement for compliance.
Example: HIV or hepatitis tests, genetic testing kits.
– Class D (High Risk): The highest risk category, applying to devices that present both high individual and public health risks, mandating a rigorous conformity assessment by a notified body.
Example: Blood typing tests, tests for infectious disease screening
Conclusion
Effective risk classification of medical and IVD devices is crucial for ensuring safety and efficacy in healthcare. Manufacturers must diligently follow specified regulations and guidelines to determine the correct classification, thereby enhancing patient safety and compliance within the market. Understanding these classifications not only assists manufacturers in regulatory compliance but also provides clarity to healthcare providers and patients regarding the use and safety of medical devices.