1. Regulatory Affairs:
A profession intended to ensure that a medical company complies with all the regulations and laws relevant to its business in order to ensure its products are safe and effective.
- Regulatory compliance: conformance of company’s processes and procedures with regulatory requirements and standards.
- Regulatory inspection: examination of company procedures and processes for compliance with regulatory and quality requirements, conducted by internal or external qualified person.
- Regulatory Agency: A national body responsible for legislation and enforcement of laws and regulations which protect the public health.
- Food and Drug Administration (FDA) – USA regulatory body, responsible for protecting and promoting public health through the regulation and supervision of foods, drugs, vaccines, medical devices, cosmetic and more. New medical products are to be submitted to FDA and clearance/approval must be obtained prior to placing the product on the US market.
- European Commission: The European Union (EU) regulatory body, it proposes new legislation to the European Parliament and the Council of the European Union, and it ensures that EU law is correctly applied by member countries. The Commission is divided into several departments one of which is responsible for public health.
- Notified Body: an organization that has been designated by a Member State of the European Union to assess whether a product meets certain requirements. The primary role of a notified body is to provide services for assessing the manufacturer’s conformity to the essential requirements listed in the directive. New medical products are to be submitted to a Notified Body to obtain a CE Mark prior to placing the product on the EU market.
- FDA Clearance: FDA’s authorization that a product may be distributed on the US market.
- CE Mark: a mandatory marking for products placed on the European Economic Area market which states that the product is assessed before being placed on the market and meets EU safety, health and environmental protection requirements. The CE Mark is to be applied on any medical product before being placed on the EU market.
- Regulatory Plan / Strategy: The regulatory path for introduction of a product to a specific market in compliance with regulatory requirements, and the actions required for its implementation.
- Regulatory submission: documents package submitted to a regulatory agency for application to market a medical product. Examples:
- 510(k); Premarket Notification: an application made to the FDA to market a medical device in the US, demonstrating that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (Device Advice: Premarket Notification)
- PMA; Premarket Approval: the most stringent type of device marketing application made to the FDA for class III medical devices, which must demonstrate that a device associated with high risk level is safe and effective (Device Advice: PMA)
- De-novo: an application requesting FDA to determine device classification for a new device which is either a new device type that has not been classified based on risk or a class III device which is determined not substantial equivalent to a marketed device. (FDA Guidance – De Novo Classification Process)
- Technical File – Design Dossier: a file containing the technical documentation related to design, manufacture and intended operation of a device, based on which a CE mark is granted.
- Medical Device:
An instrument, apparatus, software, machine, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment, cure, mitigation or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- intended to affect the structure of any function of the body.
- control of conception,
- and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
- Medical Device Classification: Each medical device belongs to a certain class, based on its intended use and the potential risk associated with it. The classification affects the design and development process, the scope of the quality system, the type of preclinical and clinical evidence required to support safety and performance, and the type of regulatory clearance/approval required prior to placing the medical device on the market.
Each regulatory authority has its own classification rules:
- EU classification: Risk based classification into 4 regulatory classes (I, IIa, IIb, III) according to device’s intended use and potential risks, as indicated by the duration of device contact with the body, degree of invasiveness and the body affected by use of the device. (MEDDEV 2.4/1 Rev.9)
- FDA classification: Risk based classification into 3 regulatory classes (I, II, III) depending on device’s intended use and indications for use and the level of control required to assure safety and effectiveness. (Device advice: Classify Your Medical Device)
2. Quality Assurance:
- Quality Management System: A set of procedures and processes defined and implemented by a medical company, intended to assure the consistent quality of the products/ services a company provides and to ensure that product or service consistently meet customer requirements and applicable regulatory requirements and standards.
- GxP: Mandatory Quality standards for Good Practice intended to promote and protect the public health by ensuring the safety and effectiveness of medical devices.
- GCP: Good Clinical Practice – designing, conducting, recording, and reporting trials that involve the participation of human subjects. Intended to ensure the safety of participants and the quality of data.
- GMP : Good Manufacturing Practice – production processes, equipment, testing, packaging, cleanliness. Intended to ensure the Quality of the finished product.
- GLP: Good Laboratory Practice – proper conduct of non-clinical safety testing, including facilities, personnel, equipment, standard operating procedures, etc. Intended to ensure the quality of test data
- International standards: documents specifying requirements intended to protect the safety and health of users and customers and which are of an international consensus. They are used for implementation of the governmental laws. Two main organizations developing international standards are the International Electro-technical Commission (IEC) and the International Organization for Standardization (ISO).
3. Pre-clinical Animal Studies: Experiments of drug, medical device or medical procedure conducted on animal/animal tissue. In Vitro and In-Vivo studies intended to obtain preliminary efficacy, toxicity and pharmacokinetic information, to assess the product safety prior to testing in humans.
4. Clinical Studies/Trials/Investigations:
Testing in human subjects intended to assess the safety and/or performance of a medical device or drug (ISO 14155 and ICH-GCP E6).
- Ethics Committee (EC): An independent committee responsible to ensure the protection of the rights and safety of people participating in a clinical study. The Ethics Committee is an independent body whose responsibility is to review and approve the conduct of clinical investigations applications in order to protect the rights, safety, and well-being of human subjects participating in a clinical investigation. (ISO 14155:2011)
- IEC – Independent Ethics Committee – the term used for Ethics Committee in European Community.
- IRB – International Review Board – the term used for Ethics Committee in the US.
5. Reimbursement: a coding-based system in which health insurance companies compensate (pay back) healthcare institutions, providers, and patients for medical services and equipment cost.
6. Clinical Application: the use of a device or treatment in clinical practice.
7. Design Control: set of practices and procedures that are incorporated into the design and development process of a product, in order to ensure that specified design requirements are met.
8. Risk Management: a process intended to identify, evaluate and control hazards and risk associated with a product, and to define methods of mitigation and risk reduction.