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.
Medical Device Manufacturers should follow the EUDAMED implementation plan and make themselves familiar with the information stored in the database’s modules. This is crucial to gain compliance in the EU market. However, the development and deployment of EUDAMED has recently changed.
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.
Under MEDDEV 2.7/1 rev 4 regulations, literature reviews play an important role in several areas of the CER, including establishment of State of the Art (SOTA). The state of the art “describes what is currently and generally considered standard of care, or best practice, for the medical condition or treatment for which the device is used.”
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.
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