UKCA postponed for 1 year
December 15, 2022
Medical device and IVD manufacturers outside of the UK are relieved at the recent announcement that the UKCA deadline has been postponed. Clin-r+ looks at this opportunity for MedTech.
Category: Regulatory Strategy
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The Impact of “Intended Purpose”
September 2, 2022
Intended Purpose states what the device is, its use, and all of the requirements in the MDR underpinned by it. Clin-r+ explain how it’s crucial to get this right from a regulatory point of view.
Transitioning to the new EU MDR
May 25, 2022
There are many key requirements to highlight for transitioning to the EU MDR from MDD. The MDR transition is certainly challenging, and a good Technical Document framework is key to success. Clin-r+ reviews what is needed and makes recommendations for compiling documents.
Economic Operators
May 23, 2022
The requirements placed on Economic Operators have changed considerably under the EU MDR. Economic Operators must verify regulatory requirements, manage complaints, and cooperate with the Notified Bodies and Competent Authorities. Clin-r+ outlines exactly who the Economic Operators are and what their roles entail.
