3rd Lecture - 5.2026 - OS - Development and testing of nanoteragnostic systems_ An overview [DVA1163]
Prof. Carmel J. Caruana Ph. D., FIPEM
Tue 12 May | 14:10–17:20
Comprehensive introduction to the regulatory pathway for medical devices, including classification, conformity assessment, clinical evaluation, CE marking, and quality management systems required for clinical implementation.
This lecture on medical device certification, delivered by a Professor of Medical Physics, highlights the mandatory legal processes and regulations governing medical devices within the European Union (EU).Core Concepts of Certification
Definition: Certification is a legal guarantee that a product conforms to relevant EU standards for safety and performance.
The CE Mark: All products sold in the EU must bear the "Conformité Européenne" (CE) mark, signifying they have passed required tests and conform to European standards.
Mandatory Nature: Selling a device in the EU without this certification is illegal.
Scope: Medical devices range from large-scale equipment like MRI scanners and linear accelerators to simple items like tongue depressors and bandages, as well as software and nanomaterials.
Key EU Regulations
The certification process is grounded in two primary pieces of legislation that became effective in May 2022:
Medical Device Regulation (MDR) 2017/745: Covers general medical devices, including implantable devices and nanomaterials.
In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746: Applies specifically to tests performed on samples taken from the human body, such as blood or tissue samples.
The Medical Device Life Cycle
Certification is integrated into a continuous life cycle consisting of two interrelated cycles:
Development Cycle (Industry): Primarily the domain of biomedical engineers, this cycle moves from initial concept and design through validation and market launch. Initial certification occurs during the validation phase.
Use Cycle (Hospital): Primarily managed by medical physicists, this includes purchasing, installation, acceptance testing, ongoing quality control, and eventual decommissioning. Renewal of certification (recertification) is based on data gathered during this phase.
Risk Classification and Assessment
Devices are classified by risk level, which determines the certification route:
Class I (Low Risk): Manufacturers may self-declare conformity.
Class IIa, IIb, and III (Higher Risk): These require assessment by a "Notified Body"—an independent third-party organization that audits the manufacturer's technical documentation and quality systems.
Nanomaterials: These are typically classified as Class III (highest risk) if there is high or medium potential for internal exposure, due to the uncertainty regarding their long-term behavior in the body.
Practical Implementation
Benefit-Risk Ratio: A device's clinical benefit must always outweigh its risks to be certified.
Post-Market Surveillance: Manufacturers must continuously collect data on device performance and safety even after they are sold and in use in hospitals.
Role of Professionals: Effective device management requires close cooperation between medical doctors (who define clinical requirements), medical physicists (who ensure technical performance and safety in the hospital), and biomedical engineers (who focus on design and manufacturing).
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