Regulatory Strategy (Ch. 5) Flashcards
What is the definition of regulatory strategy?
Regulatory Strategy:
Aligns the regulatory activities required with the business strategy, to bring a new or modified product to market in the desired regions within the desired timeframe
What are the market considerations of a regulatory strategy?
- What the company wants to achieve
- Marketplace opportunities
- National law and provisions
What is a benefit of implementing a regulatory strategy?
Allows a company to map its path forward and examine the potential pitfalls and mitigate any risks, challenges, or issues the new or revised product might face
Who should be involved in creating a regulatory strategy?
A cross-functional team!
Can include regulatory, marketing, medical/clinical, engineering, usability, reimbursement, manufacturing, quality, and other functions
(can also include outside experts - partner companies, key suppliers, or consultants)
What are the compliance, operational, and promotional considerations involved in a regulatory strategy?
- Major regulations and directives
- Conformity assessment
- Economic operators
- Quality management system (QMS)
- Marketing authorization procedure
- Promotion and advertising
What are key considerations for product development?
Intended use, product description, claims, lifecycle issues, device classification, harmonized standards and common specifications, clinical evaluation and clinical investigation, labelling and packaging, technical documentation, and postmarket surveillance technical documentation
What is the MDCG?
MDCG: Medical Device Coordination Group
What is the purpose of MDCG guidance documents?
To provide non-binding guidance that ensure uniform application of the provisions of the regulation
What are MEDDEVs?
Medical Device guidance documents written for the MDD - can be used for background info
What is CEN and Cenelec?
CEN: European Committee for Standardization
Cenelec: European Committee for Electrotechnical Standardization
TRUE/FALSE: A regulatory strategy should be documented.
True
If it isn’t documented - it doesn’t exist.
TRUE/FALSE: A notified body must approve the regulatory strategy for new product development.
False
A manufacturer is encouraged to contact a notified body or regulatory authority for a new or novel device to refine the regulatory strategy as appropriate.
TRUE/FALSE: A regulatory strategy should be reviewed periodically to address and internal or external changes that could affect the plan.
True
