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.
Set of flashcards Details
| Flashcards | 55 |
|---|---|
| Language | English |
| Category | Marketing |
| Level | University |
| Created / Updated | 02.09.2017 / 02.12.2024 |
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What is field safety corrective action?
Action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device, that is already placed on the market.
Define provisions against criminal violations of the requirements.
Criminal provision: Imprisonment for a period of 1-5 years is possible
Administrative offence: Fine of up to 25.000€ is possible
Differentiate between pro-active and re-active processes with regard to quality, safety and efficancy of medical devices.
Pro-active process: "Post market surveillance" by manufacturer:
Active supervision, e.g. by customer surveys, inquiries of users and patients, literature reviews and post market clinical follow up, notification of incidents
Re-active process: Vigilance system:
Reactive system for the notification and evaluation of adverse incidents to improve the protection of health and safety by reducing the likelyhood of the same type of adverse incident being repeated
What is a Gap analysis?
- Conducted by ISO team or third party consultant
- Used to uncover current and discover needed documentation
- Used to analyze current business processes and to strategize ISO 13485 implementation
- Gap analysis gives you a better position to establish quality objectives
Summarize major content of documentation as needed for EN ISO 13485
- Document controls
- Quality policy & manuals
- Standard operating procedures
- Work instructions
- Forms
What is clinical investigation?
clinical investigation means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device
- Proof of safety and performance
- Focus at clinical safety and performance
- Proof of the fulfilment of regulatory requirements
What is clinical data?
clinical data means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
- clinical investigation of the device
- clinical investigation reported in scientific literature, of a device which shows equivalence to the device in question
- reports published in peer reviewed scientific literature
- information coming from post-market clinical follow-up
What does clinical evaluation mean?
clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance including clinical benefits, of the device when used as intended by the manufacturer.
Differentiate preclinical testing and clinical investigation
What is a Post-market clinical follow-up (PMCF) study?
A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling.
List the major regulatory documents for clinical evaluation relevant in Germany
1. MDA
2. MPKPV
3. WMA Declaration of Helsinki
List the major regulatory documents for clinical evaluation relevant in Europe
1. EU-Directives, MDR, IVDR
2. Commision Implementing Regulation
3. EN ISO 14155, EN 13612, MEDDEV
List the major regulatory documents for clinical evaluation relevant in the US
1. FD & C Act
2. Code of Federal Regulations - CFR
3. FDA Guidance Documents
Summarize the major requirements for clinical investigations to be conducted for medical devices
- The clinical investigation is the subject of an authorisation by the member State(s) in which the clinical investigation is to be conducted
- An ethics comittee has not issued a negative opinion in relation to the clinical investigation
- vulnerable populations and subjects are appropriately protected
- the anticipated benefits justify the foreseeable risks
List major parties involved in clinical investigations
- Sponsor
- Investigator
- Ethics Committee
- Participant
- Monitor
- Competent Authority
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)
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