Regulatory Affairs
Based on the Lecture "Regulatory Affairs" by Prof. Spitzenberger, FH-Lübeck Germany. Lecture is part of the M.sc. BME. The cards are based on the learning outcomes of each slide.
Based on the Lecture "Regulatory Affairs" by Prof. Spitzenberger, FH-Lübeck Germany. Lecture is part of the M.sc. BME. The cards are based on the learning outcomes of each slide.
Kartei Details
| Karten | 55 |
|---|---|
| Sprache | English |
| Kategorie | Marketing |
| Stufe | Universität |
| Erstellt / Aktualisiert | 02.09.2017 / 02.12.2024 |
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Who or what is a Regulatory Affairs Professional?
describe his tasks and responsibilities.
- The regulatory function is vital in making safe and effective healthcare products available worldwide.
- Regulatory professionals are those who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance.
- The responsibilities of a regulatory professional reach from the r&d phases, clinical trials, premarket approvals, manufacturing, labeling, advertising and postmarket surveillance.
- Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products.
What defines a "medical device" according to European Directive 93/42/EC?
- any instrument, appliance, software or material intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes
- necessary intended to be used for human beings
- does not achieve its intended action by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.
- "articles" used in combination are also defined as medical devices
What defines a "in vitro diagnostiv medical device" according to European Directive 98/79/EC?
- a medical device with the difference that it is intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body for the purpose of providing information.
- provided information concerns a physiological or pathological state, a congenital abnormality or monitoring therapeutic measures
What defines a "medicinal device" according to Directive 2001/83/EC?
A medicinal product is any substance presented as having properties for treating or preventing disease in human beings
Or
any substance which may be used in human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmalogical.
What defines a "cosmetic product" according to Regulation (EC) No. 1223/2009?
Cosmetic product means any substance to be placed in contact with the external parts of the human body or with the teeth with a view to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
List a selection of European and US American legal documents (at least 2) for the regulation of medical devices and explain their basic purpose.
- German: Medizin Produkte Gesetz
- European Directives (90/43/EC according medical devices - 98/79/EC according in vitro diagnostic medical devices)
- European Regulations -> MDR and IVDR entry into force during 2nd quarter of 2017
- FDC Act
=> Each is responsible for protecting the public health by ensuring the safety, efficancy and security of medical devices. While EU directives also focus on supporting innovation.
Which of the following products are Medical Devices?
Explain the regulatory challenge for so called combination products.
Products which for example combine a medicinal product and a medical device are regulated either under the one regulation or under the other.
Both acts should ensure appropriate interaction in terms of consultations during pre-market assessment.
What defines an accessories?
MPG or European directive 93/42/EC:
Accessories are not in themselves medical devices, but are intended by the manufactuerer to be used in combination with a medical device to enable the latter to be used for its intended purpose.
Accessories are treated as medical devices in their own right.
What is the difference between in vitro diagnostic and in vivo diagnostic?
In vitro diagnostic medical device is a device which is intended to be used for the examination of specimens derived from the human body. (Device working outside the body)
In vivo diagnostic medical devices can be used in or on the human or animal body (device working inside the body).
Explain the basic regulatory classification for software as medical device.
-> Software as Accessory: e.g. as control software and as integral part of medical device
-> Software as Standalone-Software is definged as MD according to MPG.
-> Standalone-Software is not used for simple editing of data
-> Standalone-Software classification criteria: - Support of decision related to therapeutic measures, calculation of for dosages of medicinal products, patient monitoring unless the results influence diagnosis or therapy
Differentiate the basic hierarchy levels of regulatory documents and give examples for Germany, EU and US.
Primary legislation -> secondary legislation -> Guidance (Soft-law)
Germany: Act -> Regulation -> Richtlinien der BÄK
EU: Eu-Directive, EU-Regulation -> Commission Implementing Regulation -> MEDDEV-Guidance
US: Act -> Code of Federal Regulations -> FDA Guidance Documents
Name the basic principles of the New Approach/NLF
- Harmonized, modular approach for conformity assessment procedures leading to CE-marking
- Minimum requirements also for the activity of conformity assessment bodies
- Notification (and accreditation) of conformity assessment bodies by national control bodies
Outcomes:
==> Confidence in the quality and competence
==> Reciprocal recognition of conformity assessment results
Explain the steps for the development of European and International standards
The European Commision has a mandate at the CEN which decides on/releases ISO/IEC.
The European Commission itself releases/decides on EC-Directives and Essential requirements.
CEN/CENELEC and the EC-Directives are used for Harmonised Standards (EN, EN ISO) and translated into national standards like the DIN (DIN EN, DIN EN ISO)
Present and differentiate the fundamental elements of conformity assessment.
conformity assessment means the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled. (e.g. testing, calibraton, inspections, certification)
List basic elements which are used for choosing a class regarding risk classification of medical devices.
- Orientation towards the "vulnerability of the human body" by the respective product
- Definition of "vulnerability" by intended purpose related to application site and application duration of the product
- Especially under consideration of potential malfunctions of the products
- Results for patient, user, public health, environment,...
- Risk potential as function of probability of occurence of a damage/harm and extent of the damage/harm
Name the different device classes regarding risk classification of medical devices.
Risk Class: GHTF class:
I A
IIa and IIb B and C
III D
Present the major steps and elements of the risk management process.
I: Risk evaluation
II: Risk control
III: Risk communication (documentation)
IV: Risk Review
Start with I again.
Present to what extent the current risk categorization of IVDMD differs from the future risk categorization of IVDMD according to the European IVDR.
I am not able to answer this question.
Name the steps of the regulatory strategy.
1. Specify the intended use of the product.
2. Assign the product to the corresponding EU-legislation.
3. Classify the product according to the classification or assign the correct product category.
4. Perform the prescribed conformity assessment procedure.
List the Elements of conformity assessment for medical devices.
1. Quality Management System
2. Risk Management System
3. Technical Documentation
4. EU Declaration of Conformity
5. CE-Marking
6. System of Post-Market Surveillance (PMS)
Name the basic elements of the quality management system of a medical device manufacturer
Basic Elements:
- Quality Management
- Personnel
- Documentation
- Production
- Quality Control
- Complaints and Product Recalls
- Self Inspection/Audit
List the Content of Application of Risk management to medical devices.
1. Scope
2. Definitions
3. General Requirements for the risk management
4. Risk analysis
5. Risk evaluation
6. Risk control
7. Assessment of the acceptance of the total residual risk
8. Risk management report
9. Information from the production and from the post-production phases
Explain the main parts of the technical documentation of a medical device.
- general description of the product
- documentation of the quality system
- design information
- results of the risk analysis
- list of standards
- adequate conformity assessment data in case of combination with other devices
- labels and instructions for use
Explain the purpose of the technical documentation of a medical device.
- Technical Documentation provides the proof, that the device is in conformity with the essential requirements and for the compilation of the delcaration of conformity
- STED (Summary Technical Documentation) is a subset of the technical documentation and reflects the product status at a certain time
With increasing risk class the extent of proof in the tech. documentation increases, as well as the scope of assessment through notified bodies
Present the basic content of the EU-declaration of conformity.
- unique identification
- name and address of the issuer
- the identification of the object
- the statement of conformity
- list of standards
- date and place of issue
- signature
- any limitation on the validity
What is the CE-mark?
The CE marking indicates the conformity of the product with health and safety standards.
The CE marking is affixed on products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.
What is the purpose of the german Medizinprodukte-Verordnung?
Evaluation and assessment of the accordance with the basic requirements.
Present and differentiate major types of changes within a conformity assessment procedure.
1. Change of Product incl. Design and Production
-> Changes of the intended purpose of the device
-> Changes of the material
-> Are new hazards introduced
2. Change of Quality management system
- Is the change related to a manufacturing process
- Is the change affecting the manufacturing technologies
- Is the change affecting the location of the manufacturers activity
3. Change of Product range
- Are there additional or deleted subcategories that are designed and manufactured through the quality system
Present the major requirements of the quality management system and name the respective European medical device directives or regulations.
Directive 93/42/EEC:
-> The manufacturer must lodge an application for assessment of his quality system with a notified body.
Directive 98/79/EC:
-> technical documentation must inculde the documentation of the quality system
EU Regulation 2017/745:
The quality management system shall adress following aspects:
-> a strategy for regulatory compliance
-> identification of applicable general safety and performance requirements
-> responsibility of the management
-> resource and risk management
-> clinical evaluation
-> product realisation
-> verification of the UDI assignments
What is the purpose of the quality management system?
Observance of all aspects of production activites to assure quality
Summarize the application scope of the standard EN ISO 13485:2016
- EN ISO 13485:2016 can be used by an organization involved in one or more stages of the life cycle of a medical device.
- Requirements for a QM-System with regard to all MD
- Establishes criteria for quality management for certification and surveillance by notified bodies and competent authorities
- includes normative chapters 4-8 with requirements
Diefferentiate the major characteristics of the standards ISO 9001 and ISO 13485.
ISO 9001:2015
> Stand-alone standard
> General requirements for a QM system
> Generically applicable
> Risk based thinking for planning and realization of processes of the QM system
ISO 13485:2016
> Stand-alone standard, but based on ISO 9001 regarding general QM criteria
> Specific requirements of the QM systems for medical devices sector
> Only applicable in the sector of medical devices
> Application of risk management for the safety and performance of medical devices and with regard to the fulfilment of
regulatory requirements
What is mentioned about the topic of risk management is included in EN ISO 13485?
Risk is a combination of the probability of occurence of harm and the severity of that harm.
Note: This definition of risk differs from the definition given in ISO 9000:2015, which defines risk as the effect of uncertainty
What is mentioned in Section 4 of ISO 13485:2016? (focus on subsection 4.2)
4. Quality Management System
4.1 General requirements
4.2 Documentation requirements
4.2.3 Medical device file
The Medical device file is one or more files either containing or referencing documents generated to demonstrate compliance with applicable regulatory requirements.
What is mentioned in section 5 of ISO 13485:2016 (focus on subsection 5.2 and 5.5)
5. Management responsibility
5.1 Management commitment
5.2 Customer focus
Top management shall ensure that customer requirements and applicable regulatory requirements are determined and met.
5.3 Quality policy
5.4 Planning
5.5 Responsibility, Authority, Communication
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined, documented and communicated.
5.6 Management review
Differentiate the tasks and responsibilities of the safety manager (§30 MPG) and the person responsible for regulatory compliance (Regulation (EU) 2017/745).
Summarize and explain major elements and processes of the post market surveillance system of medical device manufacturers according to EN ISO 13485.
1. For each device, manufacturers shall plan, establish, maintain and update a post-market surveillance system.
-> The pms system shall be proportionate to the risk class and appropriate for the type of device
-> The pms system shall be an integral part of the manufacturers quality management system
2. The pms system shall be suited to actively and systematically recording and analysing data on the quality, performance and safety of a device throughout its entire lifetime and to implementing and monitoring preventive and corrective actions.
Explain major elements and processes of the vigilance system according to EN ISO 13485.
The Vigilance System is about reporting of serious incidents and field safety corrective actions.
Manufacturers of devices shall report to the relevant competent authorities:
(a) any serious incident
(b) any field safety corrective action
What is an Incident?
- Any malfunction in the characteristics and/or performance of a device
- any Inadequacy in the labeling or the instructions for use
