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  • 1.  POST-MARKET SURVEILLANCE REQUIREMENTS UK MDR

    Posted 22-Apr-2022 10:38
    Dear all,

    does anyone exactely know which post-market surveillance requirements the new UK MDR 2022 AMD 2020 provides for a manufacturer established outside UK? If I am not wrong, it seems to me that the regulation refers only to reporting dispositions regarding serious events.

    Thank you in advance

    Best regards

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    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
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  • 2.  RE: POST-MARKET SURVEILLANCE REQUIREMENTS UK MDR

    Posted 24-Apr-2022 10:58
    Hello Valentina,

    Just to confirm there is not a "new" UK medical device regulations for 2022 - there is nothing published yet; still in the so-called "transition" period for leaving the EU - magic date is June 2023.  We are expecting there will be new regulations for the United Kingdom published this year, and many including myself are patiently waiting.  Currently, the UK regulations are similar to the EU MDD so there is requirements for serious incident reporting and Field Safety Corrective Actions.  Though just as a point, the UK has had the "Yellow Card" programme in place for many, many years https://yellowcard.mhra.gov.uk/.  Even when I worked in industry when our CE Marked products were reportable in UK we used the MIR Form for other countries, but reported in the Yellow Card system for UK, which is an electronic reporting system now (MORE).  In addition, for Field Safety Corrective Actions (FSCA) or what is referred to as Field Safety Notice https://www.gov.uk/drug-device-alerts we also reported these directly to MHRA.  I know many would not like this because it is not simple, but I always found creating separate procedures for different regions cleaner within the quality management system, e.g. having a post marketing reporting procedure specific to the US, UK, Canada, etc.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: POST-MARKET SURVEILLANCE REQUIREMENTS UK MDR

    Posted 26-Apr-2022 03:51
    Thank you very much for the replies. Really clear


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    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
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    Original Message


  • 4.  RE: POST-MARKET SURVEILLANCE REQUIREMENTS UK MDR

    Posted 25-Apr-2022 05:35
    Hi Valentina

    As Richard has said, the UK situation is mostly status quo. The UK Medical Device Regulations 2002 (as amended) are essentially: UK MDR = MDD + AIMDD + IVDD + some UK specific bits. In terms of vigilance, there is little change (for now). The existing manufacturer reporting forms are still to be used. You should be able to sign up for (if you don't currently have one) a MORE account (https://aic.mhra.gov.uk/MDA/system.nsf/Registration?Open) to allow online reporting of incidents and Field Safety Corrective Actions (FSCA).

    If you are a Legal Mfr based outside of the UK, your UK representative will need to either be included in any correspondence with the MHRA on adverse incident reports/follow up investigations or FSCA; or submit these to the MHRA on your behalf.

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    Edward Ball
    Manager, Intelligence & Innovation
    United Kingdom
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    Original Message


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