Regulatory Affairs Flashcards
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
What is the purpose of annex 2?
It defines requirements for technical documentation content
What is the purpose for annex 3?
It sets out requirements for post-market surveillance
Where is the General Safety and Performance Requirement contained?
Contained in Annex I
General Safety and Performance Requirement function
Requires that all devices must be safe for end use
What is Eudamed
European database on medical devices
It should store all information on medical devices
What is the unique divide identifier (UDI)?
Allows you to identify where device was made, the n it was made etc.
Made up of 2 parts (UDI-DI and UDI-PI)
What is Common Specifications (CS)?
group-specific specifications that create a benchmark
What will occur in a no deal Brexit?
CE marked products will be recognised in the UK
UK companies will likely need new validations to sell their products in EU
What will occur if Brexit deal is finalised?
Mutual recognition
UK will have its own mark
UK - EU marks will be cross recognised
Do EU territories all have the same requirements?
No, they each have their own individual requirements
What pathways is the US FDA split into?
4 main ones
Exempted product (self-certification, well known devices)
510K (submission and approval with a predicate)
De novo (for novel devices at low risk)
PMA (pre-market approval)
What branches is FDA approval split into
Devices
Biologics
Drugs
In the US, what do you need to identify to classify your device? What happens once you have ascertained these?
-Review panel
- Product code
- Regulation number
You will now be able to identify device class and submission route
What happens if you cannot identify a regulation number in the US?
You will need to apply as de novo /PMA
What is equivalence based on?
Key items and justification / evidence to back it
It does not mean identical
What is the 510k regulatory paradigm
it is based upon substantial equivalence
What can you use to show equivalence for 510k
Multiple predicates
Reference devices
What is a special 510k?
Essentially device modification
Focuses on changes ot
f product that is already marketed via 510k
What is an abbreviated 510k?
Submission available to devices with lots of guidance documentation and established special controls
What is de novo route?
Recent alternative route to PMA, if your device has no predicate
You are essentially petitioning the FDA to introduce a new classification code and regulation number that will cover your device.
When is de novo applicable instead of PMA?
If you have low/moderate risk
When is PMA used?
For riskiest devices
How long is PMA process?
lengthy (6 months)
How much is PMA process?
Over 250k
What is Investigation Device Exemption?
It is the process to obtain approval to conduct safety and performance clinical trials within the US
What is Humanitarian Device Exemption for?
A device developed to benefit patients with a diagnosis of rare conditions / ailments
What does HDE do?
It means you are not required to demonstrate same effectiveness requirements as the others
What is a big benefit of applying with the FDA?
You get a PRE SUBMISSION DISCUSSION
This means you can ask questions to the FDA and gain insight
How is china as a secondary market?
It has its own regulatory process, it does not accept approval from other territories
Which market is generally the last one to get access into?
China
How are Canada and Australia as regular markets?
have mutual recognition with other approval territories
What happens as the market becomes more third world?
Barriers to entry become lower
Requirements become fewer
What is the Medical Device Single Audit Programme?
Combines the regulatory burden of surveillance audits worldwide into just one audit
Results in certificate allowing recognition
What is a Declaration of Conformity?
Declaration of Conformity is the document officially certifying that your product fulfils the essential requirements in the applicable CE directives.
