EU Questions Flashcards
True/False:
A manufacturer complying with all relevant harmonized standards for a device will by default have demonstrated compliance with all of the relevant Essential Requirements.
False
Medical devices intended for clinical investigations must:
Comply with all applicable Essential Requirements apart from those to be addressed by the investigations
True/False:
Postmarket surveillance is simply implementing a system and collecting data.
False
The AIMDD is only applicable to:
Active implantable medical devices and their accessories
Which of the following are mandatory for medical device compliance?
MDD Essential Requirements
Which Annex in the MDD is used to determine classification of medical devices?
Annex IX
Which of the following conformity assessment procedures performed by a Notified Body is not sufficient for active implantable medical devices to be marketed in the EU:
EC-type examination (Annex 3)
True/False:
Manufacturers of magnetic resonance imaging devices, superconducting quantum interference devices, nuclear magnetic resonance equipment and many other active devices must comply with Directive 2011/65/EU on Restriction of the Use of Hazardous Substances in Electrical and Electronic Equipment.
True
In the MDD, the list of Essential Requirements can be broken into two groups. Which of the following is
correct?
1) A set of general requirements for safety and performance that applies to all devices
2) A list of specific technical requirements with regard to design and construction that may or may not apply,
depending on the nature of the device
True/False: Only implantable devices need to be
identifiable and traceable.
False
Where no harmonized standard exists to cover the Essential Requirements, or existing harmonized standards are considered inadequate to demonstrate
conformity with the Essential Requirements, a manufacturer may adopt other standards or solutions, but these do not carry the presumption of conformity.
True
Who is ultimately responsible for the medical devices exported into the EU?
The manufacturer
Which Standard is most commonly used to meet the quality system requirements of the MDD, IVDD and
AIMDD?
EN ISO 13485
Your company is developing a new medical device that is inserted through the superior vena cava to deliver
drugs for critical care for more than 30 days. Under what classification would the device fall for creation of the technical file or design dossier?
Long term; implantable
The final vigilance report is:
A written statement summarizing the investigation
and any action based on the investigation
Medical device manufacturers need to be audited by a Notified Body unless they only manufacture which of the following types of devices?
Class I (non-sterile, non-measuring)
What type of standard takes the highest priority in terms of demonstrating compliance to the Essential Requirements of the European Medical Devices Directives?
European Normative (EN)
True/False:
Guidance documents are not legally binding and therefore not law.
True
A manufacturer in Switzerland plans to conduct clinical trials for its novel implantable medical device in France,
Germany and the UK. What authorities does it need to notify prior to commencing the trials?
The Competent Authorities in France, Germany and the UK
When were the rules relating to medical device safety and performance, following an innovative regulatory technique called the New Approach, harmonized in the EU?
1990’s
A field safety correction action (FSCA) is an action taken by:
Manufacturer or Authorised Representative
True/False:
The AIMDD covers accessories and software (e.g., image enhancing software) intended to be used with
active implantable medical devices.
True
Is design assessment by a Notified Body mandatory for AIMDs?
Yes, either via Annex 2 or Annex 3
True/False:
The AIMDD only applies to active implantable devices and should not be confused with other types of implants, including knee, hip and dental implants, that are governed by the MDD.
True
True/False:
Under the AIMDD, Annex 3 refers to EC-type examination, wherein the term “type” means a specification against which a representative sample
of the production in question should be tested.
True
