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.
Fichier Détails
| Cartes-fiches | 55 |
|---|---|
| Langue | English |
| Catégorie | Marketing |
| Niveau | Université |
| Crée / Actualisé | 02.09.2017 / 02.12.2024 |
| Lien de web |
https://card2brain.ch/box/20170902_regulatory_affairs
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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
