This EU MDR PREMIUM PACK contains most of the documents required by EU MDR. This means that you should purchase this pack if you need also all the additional templates. Otherwise, you need only to purchase the BUNDLE TECH FILE for MDR 2017/745
This PREMIM PACK contains the following documents
Documents presented individually
The documents presented below are independent of the product classification. But some of the documents are not necessary for example if your product is not a class III or Implantable like the SSCP.
We tried to give you as much guidance on the document as possible. But you may need the support of a consultant to fill up some of these documents.
Let us know if Easy Medical Device can help you.
Content of the pack
Below I provide you with a screenshot of each of the documents available. The principal document is the Technical File and for all the annexes I tried to place a document to help you.
These documents may not be specific to your product so you should adapt them. Some documents are specific to a class I like the PMS Report. For other classes this is called PSUR.
For Class III and Implantable you should normally have an SSCP. So if your product is within another class then this is not a document you should us.
So even if you have this pack, you still need to assess which elements are needed or not.
In the case this is too complex for you, Easy Medical Device can help you create your Technical File as we have done that successfully for multiple companies.
How to use this pack and create your technical file
Technical File template
Classification route
Clinical Development
Clinical Evaluation
Declaration of Conformity
Risk Management
GSPR
Master IFU
IFU Checklist
Label Checklist
UDI Checklist
PMCF Templates
PMS Templates
SSCP
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