Eu medical device technical file

NBs will carefully review if the conditions for these exceptions are fulfilled. In addition, under the MDR, the NB of a class III device manufacturer, will send a clinical evaluation assessment report to an expert panel for an additional review. The document is reviewed by the NB and shall be publicly available. Medical device manufacturers have to compile various documents, which have not been provided for under the MDD e. PMS Plan. Manufacturers of high-risk devices must set up the reports on an annual basis and the documents are reviewed and evaluated by the NB.

Further above, we looked at the generation of clinical data for an appropriate set-up of the clinical evaluation under the MDR. These are now general provisions for all manufacturers and not necessarily new. Nonetheless, the MDR is much more explicit in this regard.

Same as what I advised previously, you can also list some documents and then attach them in the annex. This will be more convenient for the reading phase. PMS is really a big topic, so a set of procedures should also be created on your Quality Management System.

He introduces to us a new feature that will help you to perform your PMS in an easier way. So we arrived at the end. I can imagine that now you understand there is a lot of work to gather all this information. This will help you to have the right structure for your technical documentation and some guidance is provided to help you understand what is expected in each section.

You can get it here. I will be happy to discuss your project with you. Just click the Red Phone logo below to activate a messenger chat. Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. My objective is to share my knowledge and experience with the community of people working in the Medical Device field. He proposes his consulting services so don't hesitate to contact him at info easymedicaldevice.

I teach you on this article all that you need to follow to put it on the market. I developed a 3 step program to put any medical device on the market. The Route Plan. You need to plan all before to start your journey. I explain to you who can be PRRC and what are its responsibilities. Don't wait to nominate yours as there are also some changes to do with the quality documentation to be fully compliant. FDA rejects a majority of the k submissions due to Substantial Equivalence issues.

We propose you to learn how to master Substantial Equivalence and always succeed. Learn also what to do in case of rejection. This article is a Step by Step process to succeed on you Substantial Equivalence section for the process K. Table of Contents. Who will review your Technical Documentation? Learn more. Where can you find the Technical Documentation information? Download ISO What is the structure of a Technical Documentation? Device description. This will provide a high-level understanding of the full technical documentation as here you will provide some information as Intended use, product name, reference numbers, variants, product classification, conformity assessment … This is really an important section to have a broad understanding of your product and also to get the different references linked to it.

What is expected also if to provide a copy of the exact labels and IFUs with version numbers etc… I recommend you to create a table with different products and document references in this section and then place true documents as an annex. Check show notes on YouTube to get more information. Design and manufacturing information. More to read on GSPR. Read More. Take a deep dive into European Technical File requirements and download our 8-page white paper.

Emergo specializes in helping medical device and IVD companies achieve CE Marking certification , and we have done so for thousands of devices. Here's a checklist of the services we provide:. What is a Declaration of Conformity DoC? It is a legally binding document. The DoC is prepared and signed as the last step in the regulatory process. How is a Technical File formatted? Benefit-risk analysis and risk management:.

Clinical Evaluation. Product verification and validation:. Technical documentation on Post market surveillance. Post market surveillance plan Post market surveillance report or Periodic safety update report. Technical File - General Information. Identification of Equivalent Device. Overview of previous and similar generations of the device with respect to state of Art. Design History. Design and Development Formulation Manufacturing information. Risk Analysis.

EN ISO is the latest updated standard. Scientific validity report Analytical performance report Clinical performance report Clinical Performance Validation has to demonstrated via: Clinical performance studies Peer-reviewed published literature Experience gained through routine testing. Most Responsible Regulatory Consultants with economic pricing and best technical team.

Class I.