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.
Composing the clinical evaluation report is one of the most difficult tasks when preparing a medical device submission under EU MDR. Clin-r+ has compiled a list of the top five most useful and reliable resources to consult when writing a CER for a medical device.
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.
Post Market Surveillance is a collection of processes and activities used to monitor the performance of a medical device. Clin-r+ identifies what your Notified Body wants to see in the Post Market Surveillance Plan and PSUR/PMSR.
The first step toward planning a route to EU MDR compliance is to be aware of any compliance gaps. Clin-r+ highlights some common gaps in clinical evaluation reports and technical documentation when transitioning from the MDD to the MDR.
Common Gaps in Clinical Evaluation Reports and Technical Documentation under the MDR Read More »
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