EU: Q&A on extended MDR transition
The European Commission has released a 10-page Q&A document on the practical aspects of the new transitional provisions for certain medical devices and iv-medical devices. These were laid down in the Regulation (EU) 2023/607, which was published on 15 March 2023 (we reported).
The pre-announced Q&A document was immediately released after the adoption of the revised timeline. It should support industry to facilitate the application of Regulation (EU) 2023/67. The focus is on making best use of the additional time provided by the extension of the MDR transitional period. Structured in four parts the document provides an overall of 18 answered questions:
- Part A: Scope of the extension of the MDR transitional period.
- Part B: Evidence of extended transitional period
- Part C: Conditions to be fulfilled to benefit from the extended MDR transition period
- Part D: Appropriate surveillance to be performed by notified bodies
- Part E: Deletion of the ‘sell-off’ date
If needed, this document will be updated to address additional questions that may arise.
Source:
EC: Q&A on the extension of the MDR transitional period and removal of the ‘sell-off’ periods
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
