RAC Exam Prep - EU MDD/AIMDD & MDR 2023 with complete solution;(Study Aid - RAC)

RAC Exam Prep - EU MDD/AIMDD & MDR 2023 with complete solution;(Study Aid - RAC) Similar but more detailed than the Essential Requirements - General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - 13485:2016 Which entity affixes it's identification number near the CE Mark? - Notified Body, if involved in the conformity assessment Un-classified devices not requiring CE mark - Custom-made, Investigational, Compassionate/Orphan All ----- contributing to the intended purpose must be considered - Modes of action Define transient use - less than 60 minutes Define short-term use - between 60 minutes and 30 days A material is considered to have a biological effect if it actively and intentionally ---- - induces, alters, or prevents a response from tissues that is mediated by specific reactions at a molecular level refers to a material's degradation within the body and metabolic elimination of the resulting degradation products from the body - Absorption Combination devices are most often classified as - Class III MEDDEV 2.4/1^7 is a guidance for - Classification under MDD Standalone software is considered what type of device - Active Software that drives a device or influences its use automatically falls in to which classification? - That of the device If a manufacturer and an NB cannot agree on the classification who is consulted for a solution? - Competent Authority How can a manufacturer appeal the CA's decision of a classification? - in the national courts Define horizontal/Level I standards - General Standards relevant to all/wide range of product types define Semi-horizontal/level 2 standards - requirements applicable to a range of similar products (surgical instruments) Define vertical/level 3 standards - apply to a single product type or narrow range of products Define comparator device - established device bearing a CE Mark that is used as a reference in a clinical investigation NOT a predicate device like FDA) What is the ISO for biocompatibility? - ISO 10993 IEC 60601 regards - - electrical safety and electric magnetic disturbance The amount of a medical device's testing is/should be commensurate with - - it's potential RISK to human health Name the two forms of clinical data used in CE marking - 1. compilation of relevant scientific literature currently available on the device's intended purpose, techniques employed and critical evaluation of the compilation 2. results and conclusions of a specifically designed clinical investigation What is contained in Annex 1 of the MDD, AIMDD and MDR? - Essential Requirements (GSPRs in MDR) A clinical evaluation is required for - - every device, Class I through III under all directives If the literature shows new or other risks what may need to be updated? - risk management plan What is not required if a manufacturer can collect clinical evidence from literature? - Clinical investigation State of the art = - current generally accepted technology and performance output not to be confused with top-of-the-line. FSCA - Field Safety Corrective Action ISO 14155 - Clinical investigations of medical devices in human subjects IB - Investigators brochure - compilation of the current clinical and non-clinical information on the investigational medical device(s) relevant to the clinical investigation. CIR - Clinical Investigation report Whish entity is legally responsible for compliance with regulations and the first point of contact for EU authorities? - Authorised Representative (as applicable, if not the manufacturer itself) Which entity is liable for defective products in the post market phase - Authorised rep EMA - European Medicines Agency Define EC type-examination - NB body reviews and, at times, performs device testing the post market surveillance concept is concept is addressed in these two ISO standards - 13485 and 14971 FSCA - Field Safety Corrective Action The criteria and procedures used by mfr's, CA's and other interested parties to notify and handle incidents and FSCA's or recalls are known collectively as the - - Medical Device Vigilance System GPSD - General Product Safety Directive What are the entities that make up the "economic operators"? - manufacturers, Authorised Reps, importers, and distributors When is a PMCF study mandatory? (MDD) - When CE marking is based solely on clinical data from equivalent devices PSUR - Periodic Safety Update Report GMDN - Global Medical Device Nomenclature is a system of internationally agreed upon generic descriptors used to identify all medical device products What are the 2 med device categories that are exempt from the full conformity assessment requirements/CE Marking? - 1. Custom Made devices 2.Devices intended for clinical investigation What is the "Blue Guide"? - guidance that explains the EU legal framework 2016 What is the Helsinki procedure? - a CA can request other CAs provide feedback on borderline devices/classification issues Which entity is responsible for enforcing compliance to directives/regulations? - Member States Competent Authority NOT the EU If a device is intended to have a biological effect or is absorbed, how does this affect classification? - Push it in to a higher class What are the 4 key classification concepts? - 1. Time Period (Transient, short/long term)