Legislators Diagnose Themselves with Loss of Control
In the United Kingdom, the MHRA's medical device regulations are being revised. As a first step, legislation for post-market surveillance (PMS) of medical devices placed on the market came into effect in revised form on 16 June 2025.
The head of the British Medicines and Healthcare products Regulatory Agency MHRA, Lawrence Tallon, speaks of ‘accelerating innovation in health technologies’ with which any serious regulation ‘must keep pace’.
And in order to keep pace with such rapid innovation, the MHRA's latest move focuses on manufacturers responsibilities.
Manufacturers under Vigilance Obligations
The changes in a nutshell: Manufacturers must now always be mentally logged into the document management system. This is because the MHRA has shortened some deadlines, requires more comprehensive and standardised reporting data, and places responsibility for data collection and provision, as well as risk assessment and mitigation, on the manufacturer.
We Have Summarised the Most Important New Obligations for Manufacturers
- (Serious) incidents must be reported more quickly (15 days instead of 30 days)
- Product safety data must be comitted to the MHRA before it is passed on to users/patients
- Submission of periodic PMS reports within 3 days of request by the MHRA
- Usage data must be collected in a standardised manner to improve comparability
- Serious incidents associated with side effects are now codified
- Faster reporting requirements for manufacturers following (serious) incidents
- Data harmonization on manufaturer side to enable faster discovery of trends and potential security vulnerabilites
- Clearer responsibilities for manufacturers in terms of risk identification and mitigation
Post-Market Surveillance is Just the Beginning
The MHRA is planning comprehensive reforms for the coming months and years. On the one hand, this is in response to what Lawrence Tallon refers to as ‘accelerated innovation’; on the other hand, it is intended to transform the British regulatory structure and further aims to address the consequences of BREXIT.
Manufacturers and importers can therefore assume that this first major update of legal standards in the UK is only the beginning of a longer and more extensive process. BEO BERLIN will keep you informed about relevant changes – stay tuned!
Smooth Sailing in Rough Times
New responsibilities for manufacturers and importers, shorter deadlines for reporting to the MHRA and rapidly changing regulatory frameworks – such hurdles all lie outside the core business of medical device manufacturers!
Fortunately, these bureaucratic intricacies are precisely the core business of BEO BERLIN! Our team is made up of a diverse combination of experts. This enables us to build a solid bridge between your company and the authorities, taking the pressure off you as a manufacturer so that you can focus on your core business: Tallon's ‘accelerating innovations’.
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