A Medical Device Regulation transition period extension request was submitted at the EPSCO Council on 9 December 2022, and a proposal was available by 6 January 2023. CLIN-r+ highlights the key elements of that proposal and the EU MDR deadlines.
How does your MDD submission translate to the MDR? Clin-r+ examines the main distinctions and what they imply for submissions made before the deadline.
What is a PRRC? The Person Responsible for Regulatory Compliance is a new EU MDR and IVDR requirement. This is to ensure that medical device manufacturers have a qualified regulatory expert. Clin-r+ explains how this works and what they need to do.
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.
The Clinical Development Plan (CDP) is a new document that you must complete for the EU MDR Technical Documentation. Clin-r+ explains how it’s an important strategic document that can help MedTech align development and regulatory requirements.
A Medical Device IFU is an essential part of your Technical Documentation. Clin-r+ provides insight and focuses on formulating an IFU to comply with EU MDR in this paper.
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.
A new feature introduced by the EU MDR is the Unique Identification Number or UDI (similar to the UIN used in the USA). A UDI is a code that identifies a certain product. It is made up of a series of numbers or letters and is made using a standard for identifying and coding devices used all over the world.
ISO 18562, has become the industry standard for testing the biocompatibility of breathing components. It has four parts: general principles, evaluation of particle emission, evaluation of volatile gas emission, and evaluation of liquid bourn leachables in condensate. Clin-r+ provides an in-depth breakdown of these four components of the standard.
The device’s design, intended use claims, composition, and clinical studies are all covered in great depth in the Technical Document. It serves as a device’s “everything you must know” manual, so CLIN-r+ looks at what it entails.
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