MEDDEV 2.7/1 Rev 4 is a Clinical Evaluation guide for manufacturers and notified bodies and the MDR provides further information on the clinical data requirements. CLIN-r+ explains the key stages of clinical evaluation and what documentation you need.
Intended Purpose, Intended Use and Indications for Use are all terms that are often confused. Not only do they sound similar, but their definitions in relation to a device can be easy to mix up. Clin-r+ explains what they actually mean.
Intended Purpose, Intended Use, and Indications for Use Read More »
Starting an EU MDR gap analysis of your FDA 510K submission early on will speed up your progress in both the US and EU markets. FDA and MDR definitions differ. Clin-r+ advises on how they compare.
Translating your FDA 510K to an EU MDR submission Read More »
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.
Person Responsible for Regulatory Compliance (PRRC) Read More »
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.
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