QA and Regulatory team members are always confused or find it difficult in identifying the required number of medical device technical file for the products planned for European CE Marking. It is advised to remember that medical device technical file or documentation is all about your device to establish safety and performance. It means you cannot combine products with the different intended use, or different class, or different construction material, or even different design.
A group of professionals experienced in EU Medical Device CE Marking covering core technical areas such as risk analysis, validations, design, shelf-life, usability, biological evaluation, safety, chemical characteristics, and clinical evaluation is called experts and such a group of experts makes us a team called I3CGLOBAL.
You can directly contact us for technical file preparation. MDR has given specific requirements on what to include in your technical documentation. Audit the QM system. Authorized representative. Risk Management ISO Clinical Evaluation. Performance evaluation of IVDs. FDA relevant documents. Product test Human Factors Research. Safety and EMC test laboratory. Computer System Validation. Approval Regulatory Affairs. About us The Company Our Mission.
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Medical Devices as Disability Aids. In addition to the technical file, medical device manufacturers must establish, document and implement a proper quality management system and maintain its effectiveness throughout the lifecycle of the devices concerned.
The medical device technical file can be in both paper and electronic format since there are no legal requirements regarding its structure and format. However, the documentation must always be up to date, including the latest modifications to the medical device or amendments in the MDR and any other relevant regulations. Lastly, according to Articles 38 and 39 of the MDR, all documents part of the medical device technical file must be in a language determined by the Member State concerned.
Generally, an official Union language such as English is accepted. A flowchart would make sense. So I recommend you to use a third party to evaluate if this is understandable. The problem with a Notified Body question is not the question, it is the time that you will lose to finalize the review. More questions there is, less time the reviewer will have to finalize your dossier. Because while you will work on the answer to the question, he will start to work on another dossier.
So you are back in the queue. For example, you should mention the entity that performed the design in the case not done by you. Same if you are the legal manufacturer but not the manufacturer. I am thinking for example of companies that need the support of other entities to manufacture the product for them.
Additionally, you should also list your critical suppliers as the entities performing sterilization, cleaning, final inspection, assembly, packaging…. There are some differences in the wording and also some new requirements. This is a template that you should fill by providing a proof for all the 23 requirements listed.
Check my shop. This is section is important as this is to define the risks related to your products. For medical device companies, this is following ISO So you need to have a procedure for risk management and then issue some risk assessment for your products. This risk assessment can have multiple formats but the most known one is the FMEA format.
You will then identify the risk related to your products. But this may be the subject of another blog post as this can be complicated.
So this is important to include them in this section to be sure to be compliant to it. I think this section will be the most important one to prove the safety and performance of your product. So stay focused. This section is related to the product itself in terms of all the tests that you should do to provide evidence of:. So be patient when you are building this section of the technical documentation as you will have to review each of those elements and provide a piece of evidence that you comply with the requirements.
For example, there are some combination products or products that use animal tissue or products that contain CMRs. If this is applicable you should complete the related section on the Technical Documentation. All the clinical data are critical to proving the safety of your product. Without clinical data, you will not be able to get approval from your Notified Body. See below. This is specific to Post-market Surveillance. There is now an emphasis t to perform a proactive review of the performance of your product.
All this information should be available for review on your technical documentation. 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.
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