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  • Implication of EU MDR Deadline on 26th May 2021

    You have to check that with Notify's body. Basically, certification under MDD is possible until May 2021, but Notify bodies to have their own dates until it is possible to certify the medical devices under the MDD.

    CE Certificate that will be issued before May 2021 under the MDD is valid until 26/05/2024. 

    However, be aware that periodic audits that will be performed after May 2021 – therefore period audits that will be performed under the MDR – will require certain documentation to be ready according to the MDR requirements. First of all, this refers to the Post-market surveillance system. This process needs to be in place in accordance with the MDR requirements on the first periodic audit. It means the following for example: if you receive an MDD audit in April 2021, your first-period audit will be in April 2022. On that periodic audit, your post-market surveillance system must be in place according to the MDR requirements.  

  • Required process documentation for certification

    What process documentation from across the company is required for certification?

  • Inventory management

    There is no direct requirement in the ISO 13485:2016 that cover inventory management. In requirement 5.1 Management commitment is stated that management must ensure the availability of resources. Furthermore, in 6.1 Provision of resources is stated that top management must determine and provide resources needed to implement the quality management system and to meet applicable regulatory and customer requirements.

    Inventory management usually considering to determine the vital stock levels. Following steps can be used to control your stock levels: establishing levels of operating stocks based on consumption/rate of usage; maintain periodically stock usage reports of each item kept in the store; establishing quantity, lead time, and availability of each item supplied on the market; keeping a record of all non-stock items received from suppliers, returned to suppliers and issued out to users.

    Of course, as inventory management important is to have under control shelf life of both raw and packaging material and final goods; to follow the FIFO (first in first out) or FEFO (first expire first out) principle, which you find most useful for your type of production. 

    The following article can be helpful:

    You can see how we describe this process in our procedure for warehousing in our ISO 13485:2016 documentation toolkit:

Page 259-vs-13485 of 1130 pages

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