2024-05-02

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Do you have a Class I device that will be up-classified under MDR EU 2017/745? 

Are you ready for 26th May 2024 deadline? 

The clock is ticking…. 

We have been advising that there is less than 1 month to go, until the first critical deadline (26th May 2024) for legal manufacturers of legacy devices who wish to take full advantage of the extension provision covered in EU 2023/607.  

If you are a legal manufacturer who has a Class I medical device (under previous Directives) that under MDR EU 2017/745 is up-classified, you can continue to place your device/s on the market until 31 December 2028, if certain criteria are met: 

    • Continue to comply with Directive
    • No significant changes
    • No unacceptable risk
    • MDR compliant QMS (EU MDR Article 10 part 9) in place by 26th May 2024 
    • MDR application by 26th May 2024 
    • Signed MDR Agreement by 26th Sep 2024 
    • Transfer appropriate surveillance to EU MDR Notified Body (if different from Directive Notified Body) 

    If you are a legacy device legal manufacturer of Class I medical devices (under previous Directives) that under MDR EU 2017/745 is up-classified, and who wishes to continue to place devices on either EU or UK (unless already certified under UK MDR2002) after 26th May 2024 it is essential that you have:

        1. Submitted an EU MDR application with an EU Notified Body (EUROPA – European Commission EU 2017/745 designated Notified Bodies)  

          1. Established a quality management system that meets the requirements of MDR (EU 2017/745) Article 10(9)  

        Once your application has been made then preparations should continue building your MDR compliant technical documentation. Advena can assist in conducting gap analyses, reviewing draft technical documentation and/or help you build your technical documentation, so it is ready for when called for review by your Notified Body. 

        If you either have a ISO 13485 compliant quality management system, no quality management system (QMS) or perhaps only ISO 9001 certification, you will need to ensure you have a QMS that includes all the MDR (EU 2017/745) Article 10(9) requirements.  

        If you have or intend to use a paper-based system or Windows based document storage system, have you considered moving to an electronic QMS (eQMS)?  Activ is a cost effective, easy-to-use option to manage your QMS, that frees up the time of the person responsible for your quality system. 

        Please review further information regarding Activ via our website https://advenamedical.com/activ-eqms-software/  

        Please feel free to reach out to Advena via either our website contact page, email (info@advena.com) or phone (01926 800153) to start a conversation today.