MDCG updates guidance on IVD verification and vigilance reporting
The Medical Device Coordination Group (MDCG) has released two revised documents providing updated guidance for the medical device industry.
This subtopic includes a selection of definitions and standard commercial clauses for use in agreements in the life sciences sector.
For boilerplate commercial clauses and standard definitions which may be used in life sciences agreements, see: Boilerplate clauses—overview and Definitions—overview.
For a summary of the law, guidance and practice in relation to the execution of documents, along with standard execution clauses, see: Execution—overview.
For examples of definitions which are frequently used in life sciences agreements, see Precedents:
Applicable Laws and Medical Product Law definitions—life sciences
Clinical trial laws definition—life sciences
Derivatives definition—life sciences
EU Notified Body and UK Approved Body definition—life sciences
Exploit definition—life sciences
Good Clinical Practice (GCP) definition—life sciences
Good Laboratory Practice (GLP) definition—life sciences
Governmental Entity definition—life sciences
Industry Practice definition—life sciences
Material definition—life sciences
Principal investigator (PI) definition—life sciences
Product definition—life sciences
Progeny definition—life sciences
Regulatory Documentation definition—life sciences
Regulatory Approvals definition—life sciences
Regulatory Authority definition—life sciences
Intellectual
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