General Safety and Performance Requirements and Technical Documentation (Ch. 10) Flashcards
What are some of the benefits of the new EU MDR and IVDR?
Modernize the current system and address opportunities for improvement, strengthen PMS, reinforce clinical evidence, introduce implant cards, increase transparency, new risk classification system for IVDs, reinforce NB oversight, and increased control of high-risk devices
What does GSPR stand for?
GSPR: General Safety and Performance Requirements
What are the 3 categories of the GSPRs?
- General requirements
- Requirements regarding design and manufacture
- Requirements regarding the information supplied with the device
TRUE/FALSE: The technical documentation is a set of living documents that evolves during the premarket phase of device development.
FALSE!
Evolves throughout the lifecycle of a product
What is the purpose of the GSPRs?
To ensure patient safety
Who developed the “Essential Principles” concept?
The GHTF - Global Harmonization Task Force
What are the basic principles of medical device regulations, as summarized in the GSPRs?
- Cannot compromise patient safety or user’s clinical condition
- Risks must be acceptable when weighed against its benefits
- Risks must be eliminated or minimized in line with the state of the art
- Devices must perform as intended by the manufacturer
What are the main topics in the GSPRs?
- Chemical, physical, and biological properties
- Infection and microbial contamination
- Devices incorporating a medicinal product and devices composed of substances or of combinations of substances that are absorbed by or locally dispersed in the body
- Devices incorporating materials of biological origin
- Construction of devices and interaction with their environment
- Devices with a diagnostic or measuring function
- Protection against radiation
- Active devices and devices connected to them
- Active implantable devices
- Protection against mechanical and thermal risks
- Devices supplying energy or substances
- Information supplied by the manufacturer
What is the IMDRF’s view of consensus standards?
A tool for harmonizing regulatory processes to ensure medical devices’ safety, quality, and performance
(IMDRF: International Medical Device Regulators Forum)
How does ISO define a standard?
Standard: A document, established by consensus and approved by a recognized body, which provides for common and repeated use, rules, guidelines, or characteristics for activities or their results aimed at the achievement of the optimum degree of order in a given context
(ISO: International Organization for Standardization)
What is the process for standard harmonization in the EU?
- The European Commission mandates CEN or CENELEC to develop a standard to demonstrate GSPR compliance
- Standard is developed, in cooperation with ISO
- A dual EN/ISO standard is published
- Approved by CEN to verify it adequately demonstrates conformity assessment
- Then published in the Official Journal (OJ) - called “harmonization”
- The resulting standard is then called a “harmonized European standard”
What is the purpose of the annex in a European harmonized standard?
Annex: indicates the GSPRs that the standard is deemed relevant
What do you do if there are no harmonized standards?
- An ISO standard may be used when there’s not a CEN standard
- National or in-house standards (SOP’s) can be used next
Note: Using harmonized standards is not required
What are Level 1 (horizontal) standards?
Level 1 (horizontal) standards: generic standards that are relevant to all devices or a wide range of product types (Ex. ISO 13485, ISO 14971, ISO 10993, ISO 11737)
What are Level 2 (semi-horizontal) standards?
Level 2 (semi-horizontal) standards: requirements for a range of similar products (Ex. endovascular devices or surgical instruments)
