ISO 13485 & EU MDR - Expert Advice Community



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  • Clinical evaluation requirements for Class I self-certified devices

    If a class I self-certified medical devices manufacturer has minimal clinical evaluation data due to the fact that most of the devices have been designed and manufactured as equivalent to those from other manufacturers, which would be the best route to comply with clinical requirements according to the MDR? There are records regarding CAPAs, complaints and customer feedback available, but no data from clinical studies or PMCF. The company has been compliant with MDD from this point of view by stating that it was not necessary to conduct a clinical evaluation based on clinical data (literature route/ clinical investigation) caused by the use of an harmonised standard for the products.

    Thank you for your support. 

  • MDR Accessories

    Please could you provide advise on the following situation:

    If a part of a medical device is attached to the device, it becomes a component, but if the same part is provided separately to the user in order to fulfil the medical device`s intended purpose, it becomes an accessory. Is that correct?

    Considering the scope and requirements of the MDR, the components are a part of the medical device itself which goes through the certification process. If the components are manufactured in bulk, kept in stock, and attached to the final product to fulfil the orders requirements, is it required for them to have the date of manufacture on them, or would the date of manufacture provided on the medical device itself would suffice?

    How about the accessories? Do they need to go through the same process as the medical device itself (e.g. have clinical evaluation, technical documentation, DoC, UDI, labelling in compliance with the MDR, PMS, etc.)? If in order to fulfil an order they are supplied separately and additionally to the medical device itself - in a separate bag, would the accessories need to have their CE mark, date of manufacture, and/or serial number on their label in order to be compliant, or is this not a requirement?

  • Why ISO 13485 didn't implement changes and format of ISO 9001:2015 edition?

    Why did ISO 13485 not remain in line with the ISO 9001 standard and did not implement the changes and the format of the 9001:2015 edition?

  • Implementation questions

    1. How does one determine an organization has enough employees to do the work?
    What sort of things need to be looked at, to ensure a company is adequately staffed?

    2. What sort of things can we do to determine training effectiveness?  At the initial training we can have an on the job training or when someone observes you and signs you off on a particular task, but after
    What are some industry standard practices.

    3. Also if my company has an Asset Management, Gowning SOP, Environmental Monitoring and Pest Control procedure that cover the different points in your toolkit example for the infrastructure and work environment procedure will that be good enough or does the information need to live in one document titled “Infrastructure and Work Environment?”

  • Does Medicine Product Class 1 need Certificate from Notified bodies according to ISO 13485?

    I attended the Webinar “Overview of steps needed to comply with EU MDR”

    Who needs to get certified: included Manufacturer of Class 1 medical devices. What do you mean by certifying? Does it mean to get certified by ISO 13485:2016?

    To be honest I have studied the complete EU MDR. By attending your Seminars and Q/A sessions. I understand the Medicine Product Class 1 does not need the Certificate from Notified bodies according to ISO 13485.

    We just need to prepare our QMS according to ISO 13485 and EU MDR.

    If I am understanding it wrong please guide me accordingly.

  • Would medical face mask necessarily need UV radiation sterilization?

    Just curious would a medical face mask necessarily need UV radiation sterilization? Currently I am planning to certify under ISO 13485 in order to supply medical face mask to hospital and healthcare center. Thank you!

  • ISO 13485 requirements for virtual IVD manufacturer

    Hi there, I will like some advice on the ISO13485 requirements for a virtual IVD manufacturer which only designs the device?

  • Issues from MDD to MDR in terms of mainly clinical evaluation and investigation

    Issues from MDD to MDR in terms of mainly clinical evaluation and investigation, classification, etc.

  • How to effectively use CAPA to improve Quality Management Systems?

     I need to learn to how to effectively use CAPA to improve Quality Management Systems under ISO 13485

  • MDR Technical Documentation

    1. Is it acceptable under MDR to have Technical Documentation for medical device families rather than for every individual medical device?

    2. Is it acceptable under MDR to group medical device families based on the basic design and performance characteristics related to safety, intended use and function as defined in ISO 13485:2016?

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