Regulatory Affairs Flashcards
(58 cards)
Why do medical devices require strict regulations?
To protect the safety and wellbeing of patients and end-users
Regulatory bodies have implemented regulations to ensure that MDs released on the market are:
- Safe for intended use
- Have medical benefit that exceeds risk
- Fulfil requirements for intended use
What is a MD?
Any instrument, apparatus, appliance (used alone or in combination) to be used by human beings for the purpose of:
- Diagnosis, prevention, monitoring, tx
- investigation, replacement or modification of anatomy
- Control of conception
(NOT BY PHARMACOLOGICAL MEANS, although may be assisted by them)
What is an active MD?
MD relying for its function on a source of energy other than energy of the body or gravity
What is an active implantable MD?
An active MD intended to be introduced into the human body or a natural orifice
What is an in vitro diagnostic MD?
MD intended to be used in vitro for examination of. specimens
What is an intended use?
An intended use is how your medical device addresses (treats/alleviates) the medical condition you with to address
What is an indication for use?
An indication for use is the actual situational use of the device (specific medical need the device is used for)
How are medical device companies structured to navigate regulatory needs?
They have different departments
- Regulatory
- Quality
- R&D
- Production, manufacturing
- Legal
What is the regulatory department responsible for?
For advising through the design and development process
For submission to regulatory bodies for approval
It has pre-market, post-market and interfacing roles.
How does the quality department work?
They are obligated to operate a QMS (Quality Management System)
They control quality internally
How does R&D work?
They lead the process to product realisation through design and development
What do R&D look at?
User needs
User input
User output
Verification, validation
What is the purpose of the clinical department?
Demonstrate that clinical data supports MD’s performance, and that clinically known benefits outweigh risks
Does proving clinical benefit always require a trial?
No, you may be able to use the equivalency argument
If an existing product is similar enough, you can prove it through the literature
- Can be sufficiently demonstrated by literature route or a combination of both
– Works well for well established. technologies
– Requires predicates that are biologically, technically and clinically equivalent
What does Competent Authority do in EU market?
It controls the process and implementation of a directive
It is involved in Class I devices and clinical trial applications
What does the Notified body do?
It enforces approvals and conducts surveillance audits
Where must the legal manufacturer be, for a MD sold on EU market?
Must be within the EU
What happens if if there is no literature/predicates that are equivalent, and you need to prove clinical benefit?
You need to prove both performance and safety through 2 phase clinical trial
What is the classification for medical devices in the EU defined by?
Invasiveness and exposure time
What are the classes for MD in EU?
Class I
IIa
IIb
III
What annex are these classes defined in?
Annex 8
What else will these classes require?
A declaration of conformity
What annexes are used to demonstrate conformity?
9,10,11
